<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03755284</url>
  </required_header>
  <id_info>
    <org_study_id>Sacral Massage</org_study_id>
    <nct_id>NCT03755284</nct_id>
  </id_info>
  <brief_title>The Effect of Sacral Massage on Labor</brief_title>
  <official_title>The Effect Of Sacral Massage On Labour Pain and Anxiety: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semra Çevik, phD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Gaziantep</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nonpharmacologic pain control methods, which are increasingly becoming widespread in coping&#xD;
      with the labour pain, are the methods that allow women to completely relax without using any&#xD;
      medication and direct them to perceive the pain at the lowest level. This study was conducted&#xD;
      to determine the effect of sacral massage, on labour pain and anxiety. This study was&#xD;
      conducted as a randomized controlled experimental study at Bağcılar Training and Research&#xD;
      Hospital, Obstetrics and Gynecology Clinic between March and October 2016.&#xD;
&#xD;
      Hypotheses of the Study&#xD;
&#xD;
        1. Massage applied to the sacral region decreases the perception of a woman's labour pain.&#xD;
&#xD;
        2. Massage applied to the sacral region decreases the woman's levels of concern and anxiety&#xD;
           about labour.&#xD;
&#xD;
        3. Massage applied to the sacral region increases the woman's satisfaction with the labour&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design&#xD;
&#xD;
      This was a randomized and controlled experimental study aimed to determine the effects of&#xD;
      sacral massage on labour pain and anxiety.&#xD;
&#xD;
      Setting and samples&#xD;
&#xD;
      The study was performed in volunteer pregnant women who applied to xxx Training and Research&#xD;
      Hospital, Delivery Unit, to undergo their first labour between January 25 and October 25,&#xD;
      2016. This unit contains 1 delivery room (with 2 tables), 2 labour follow-up rooms (with 5&#xD;
      beds), 1 postpartum room (with 5 beds) and 1 nursing room.&#xD;
&#xD;
      According to hospital records, in all, 342 pregnant women who applied to xxx Training and&#xD;
      Research Hospital, Delivery Unit to undergo their first labour between January 25 and October&#xD;
      25, 2016, constituted the population of the study. The following inclusion criteria were used&#xD;
      to determine participation in the study: (1) 19-40-year-old primiparous pregnant women;(2)&#xD;
      Singleton pregnancies between 38-42 weeks; (3) Pregnant women whose labour began&#xD;
      spontaneously; (4) Pregnant women with a healthy foetus; (5) Pregnant women without any&#xD;
      complications that may cause dystocia during labour; (6) Pregnant women for whom analgesia&#xD;
      and anaesthesia were not used during the first phase of labour; (7) Pregnant women who&#xD;
      volunteered to participate in the research and who could establish verbal communication. In&#xD;
      addition, Pregnant women with high-risk pregnancies, with caesarean section indication, and&#xD;
      Pregnant women with a chronic illness were excluded.&#xD;
&#xD;
      The sample size was calculated by Medical Faculty Biostatistics Department using Minitab&#xD;
      Program. The sample volume to represent the population was determined as minimum 30 people&#xD;
      for each group when considering comparison results of mean scores in the study of Field.,&#xD;
      with a risk of α= 0.05, an accuracy rate of 1-α =0.95 and a power ratio of B= 0.20, 1-B=&#xD;
      0.80.&#xD;
&#xD;
      The study was conducted with two groups, namely Massage Group (experimental), and Control&#xD;
      Group. 30 pregnant women were included in each group; therefore, the study was conducted with&#xD;
      a total of 60 pregnant women. The women who participated in the study were randomized&#xD;
      randomly as control (double) and experimental (single) groups according to the single or&#xD;
      double patient admission numbers. The women who participated in the study were randomized&#xD;
      into either the control (double) or the experimental (single) group according to single or&#xD;
      double patient admission numbers.&#xD;
&#xD;
      Measurements&#xD;
&#xD;
      In this study, the Questionnaire form, Birth action follow-up form, postpartum interview form&#xD;
      ,Visual analogue scale (VAS) and State-trait anxiety inventory (STAI FORM TX-I) were used to&#xD;
      collect the data.&#xD;
&#xD;
        1. Questionnaire Form: Questions that reflect the sociodemographic characteristics of the&#xD;
           patients (age, educational status, social security, marital status), information about&#xD;
           pregnancy (drugs used, status of their willingness to become pregnant, gestational week,&#xD;
           status of attending examinations, status of collecting information about labour), the&#xD;
           methods used to cope with the pain, and open-ended questions that evaluate the previous&#xD;
           use of massage.&#xD;
&#xD;
        2. Birth Action Follow-Up Form: The questions that indicate the length of the first phase,&#xD;
           the interventions performed to shorten the first phase of labour, the methods used by&#xD;
           the patient to cope with the labour pain, the emotional behaviours of the pregnant women&#xD;
           during labour, the length of the second phase, adjustment of the pregnant women, the&#xD;
           presence of intervention in labour, the status of episiotomy, the total duration of&#xD;
           labour and the baby's health.&#xD;
&#xD;
        3. Postpartum Interview Form: Open and closed questions that indicate the pregnant women's&#xD;
           thoughts about labour, the status of overall satisfaction with labour and how the women&#xD;
           feel were included in this form, which was prepared by a researcher in accordance with&#xD;
           the relevant literature.&#xD;
&#xD;
        4. Visual Analogue Scale (VAS): The Visual Analogue Scale (VAS) was used to measure the&#xD;
           severity of labour pain. On this scale, numbers from 0 to 10 appear on a horizontal line&#xD;
           of 100 mm. The pain level is expressed in figures that range from 0 to 10, as follows:&#xD;
           the absence of pain is indicated by &quot;0&quot;, while the most severe pain is indicated by&#xD;
           &quot;10&quot;. In this method, it is explained to the individual that there are two endpoints and&#xD;
           that he/she is free to mark any point that defines his/her pain.&#xD;
&#xD;
           The VAS was applied to the participants in the control group three times in the latent&#xD;
           (3-4 cm), active (5-7 cm) and transition phases (8-10 cm) of labour. The VAS was also&#xD;
           applied to those in the experimental group two times before and after the massage in&#xD;
           each phase. The diagnosis was made in accordance with the subjective data including the&#xD;
           patient's verbal expression.&#xD;
&#xD;
        5. State-Trait Anxiety Inventory (STAI FORM TX-I): To determine state and trait anxiety&#xD;
           levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was&#xD;
           used. The individual is required to indicate the feelings or behaviours that he/she has&#xD;
           experienced in a specific situation according to the degree of severity by marking one&#xD;
           of the options such as (1) Never, (2) Little, (3) Very and (4) Completely. The&#xD;
           state-trait anxiety inventory requires the individual to describe how he/she feels at a&#xD;
           certain moment and under certain conditions by considering his/her feelings about a&#xD;
           specific situation. While high scores indicate high anxiety levels, low scores indicate&#xD;
           low anxiety levels. The state-trait anxiety inventory consists of 20 statements. The&#xD;
           score obtained from the scale may vary between 20 and 80. While a high score represents&#xD;
           a high anxiety level, a low score represents a low anxiety level. In the scoring&#xD;
           performed in accordance with the criteria directive, 0-19 points are regarded as &quot;none&quot;,&#xD;
           20-39 points are regarded as &quot;mild anxiety&quot;, 40-59 points are regarded as &quot;moderate&#xD;
           anxiety&quot;, 60-79 points are regarded as &quot;heavy anxiety&quot; and 80 points are regarded as&#xD;
           &quot;severe anxiety&quot;. In our study, the STAI FORM TX-I was used in the active (5-7 cm) phase&#xD;
           in the control group and in the active (5-7 cm) phase after the massage in the&#xD;
           experimental group to evaluate the anxiety experienced by women during labour.&#xD;
&#xD;
      Data Collection&#xD;
&#xD;
      After approval and permission to conduct the study were obtained from the ethics committee,&#xD;
      the hospital's head nurse, delivery room charge nurse/midwife and other midwives and nurses&#xD;
      were interviewed and informed about the purpose and scope of the study. Data were collected&#xD;
      by one of the researchers. The researcher was aware of which patients were assigned to each&#xD;
      group. However, the researchers did not interfere in any way with the study results. When&#xD;
      they encountered women who met the inclusion criteria of the study, the purpose of the study&#xD;
      was explained, and written consents were received from those who agreed to participate in the&#xD;
      study. For the women who satisfied the criteria, participation in the study was voluntary.&#xD;
      Additionally, during the study, no women requested to withdraw and no women were excluded&#xD;
      from the study. Routine care and treatments for the women continued during data collection.&#xD;
&#xD;
      Procedure&#xD;
&#xD;
      Before the research data were collected, an informative meeting regarding the purpose and&#xD;
      scope of the study was held for the members of the healthcare team who worked in the&#xD;
      obstetrics and gynaecology clinic of the Turkish Republic Ministry of Health Public Hospitals&#xD;
      Administration of Turkey, at the Istanbul Province xxx Training and Research Hospital, where&#xD;
      the study would be conducted. In addition, cooperation was provided by the members of the&#xD;
      healthcare team. For the correct application of the massage, the researcher was trained by&#xD;
      the physical therapist who work at hospital. The massage was applied only to the pregnant&#xD;
      women in the intervention group at every phase of labour. There was no intervention in the&#xD;
      control group except for routine hospital applications. The steps taken in this study are&#xD;
      discussed below.&#xD;
&#xD;
      For the pregnant women included in the experimental group:&#xD;
&#xD;
        -  One-on-one interviews were conducted with the pregnant women, and the voluntary&#xD;
           disclosure forms, which explained the purpose of the study, were completed.&#xD;
&#xD;
        -  The prepared questionnaire form was applied.&#xD;
&#xD;
        -  In addition to providing them with routine nursing/midwifery care, the women in the&#xD;
           experimental group were administered a massage to the sacral region under the&#xD;
           supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and&#xD;
           vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition&#xD;
           (8-10 cm) phases of labour. To achieve this, the patients were placed in the left&#xD;
           lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases&#xD;
           of labour.&#xD;
&#xD;
        -  The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated after the&#xD;
           massage in the active (5-7 cm) phase.&#xD;
&#xD;
        -  The Visual Analogue Scale (VAS) was evaluated once after the massage in the latent (3-4&#xD;
           cm), active (5-7 cm) and transition (8-10 cm) phases.&#xD;
&#xD;
        -  Birth action follow-up form and postpartum interview forms were applied.&#xD;
&#xD;
      For the pregnant women included in the control group:&#xD;
&#xD;
        -  One-on-one interviews were conducted with the pregnant women, and the voluntary&#xD;
           disclosure forms, which explained the purpose of the study, were completed.&#xD;
&#xD;
        -  The prepared questionnaire form was applied.&#xD;
&#xD;
        -  Routine nursing/midwifery care was applied.&#xD;
&#xD;
        -  The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated in the&#xD;
           active (5-7 cm) phase.&#xD;
&#xD;
        -  The Visual Analogue Scale (VAS) was evaluated once in the latent (3-4 cm), active (5-7&#xD;
           cm) and transition (8-10 cm) phases.&#xD;
&#xD;
        -  Birth action follow-up form and postpartum interview forms were applied One-on-one&#xD;
           interviews were conducted with the women in both groups, and the voluntary disclosure&#xD;
           forms, which explained the purpose of the study, were completed. After the prepared&#xD;
           questionnaire form was applied to the women in the experimental group, routine&#xD;
           nursing/midwifery care was provided.&#xD;
&#xD;
      Data analysis&#xD;
&#xD;
      In the evaluation of the data, in addition to descriptive statistical methods (e.g.,&#xD;
      percentage, frequency, mean, and standard deviation), the chi-square test and Student's&#xD;
      t-test were used in the comparison of the qualitative data. The results were evaluated at a&#xD;
      significance level of p &lt;0.05.&#xD;
&#xD;
      The dependent variables of the study are the pain score averages of the pregnant women, the&#xD;
      duration of the latent, active and transition phases of labour, and the anxiety level score.&#xD;
      The independent variables of the study are the pregnant women's age, educational status,&#xD;
      working status, and prenatal educational status, as well as the educational status of the&#xD;
      husbands of the pregnant women, their willingness to become pregnant and the willingness to&#xD;
      serve as controls before labour.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2016</start_date>
  <completion_date type="Actual">October 25, 2016</completion_date>
  <primary_completion_date type="Actual">October 25, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomized and controlled experimental study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The state-trait anxiety inventory (STAI FORM TX-I) evaluated</measure>
    <time_frame>6 hours</time_frame>
    <description>The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated after the massage in the active (5-7 cm) phase.To determine state and trait anxiety levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was used. The individual is required to indicate the feelings or behaviours that he/she has experienced in a specific situation according to the degree of severity by marking one of the options such as (1) Never, (2) Little, (3) Very and (4) Completely.the STAI FORM TX-I was used in the active (5-7 cm) phase in the control group and in the active (5-7 cm) phase after the massage in the experimental group to evaluate the anxiety experienced by women during labour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Visual Analogue Scale (VAS) evaluated</measure>
    <time_frame>6 hours</time_frame>
    <description>The Visual Analogue Scale (VAS) was used to measure the severity of labour pain. On this scale, numbers from 0 to 10 appear on a horizontal line of 100 mm. The pain level is expressed in figures that range from 0 to 10, as follows: the absence of pain is indicated by &quot;0&quot;, while the most severe pain is indicated by &quot;10&quot;. In this method, it is explained to the individual that there are two endpoints and that he/she is free to mark any point that defines his/her pain.The VAS was applied to the participants in the control group once in the latent (3-4 cm), active (5-7 cm) and transition phases (8-10 cm) of labour. The VAS was also applied to those in the experimental group once after the massage in each phase.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>sacral Massage Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The massage was applied only to the pregnant women in the intervention group at every phase of labour. There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below.&#xD;
For the pregnant women included in the experimental group:&#xD;
In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below.&#xD;
One-on-one interviews were conducted with the pregnant women, and the voluntary disclosure forms, which explained the purpose of the study, were completed.&#xD;
The prepared questionnaire form was applied. Routine nursing/midwifery care was applied. The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated in the active (5-7 cm) phase.&#xD;
The Visual Analogue Scale (VAS) was evaluated once in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases.&#xD;
Birth action follow-up form and postpartum interview forms were applied</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sacral Massage</intervention_name>
    <description>● In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.</description>
    <arm_group_label>sacral Massage Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 19-40-year-old primiparous pregnant women;&#xD;
&#xD;
          2. Singleton pregnancies between 38-42 weeks;&#xD;
&#xD;
          3. Pregnant women whose labour began spontaneously;&#xD;
&#xD;
          4. Pregnant women with a healthy foetus;&#xD;
&#xD;
          5. Pregnant women without any complications that may cause dystocia during labour;&#xD;
&#xD;
          6. Pregnant women for whom analgesia and anaesthesia were not used during the first phase&#xD;
             of labour;&#xD;
&#xD;
          7. Pregnant women who volunteered to participate in the research and who could establish&#xD;
             verbal communication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women with high-risk pregnancies, with caesarean section indication, and&#xD;
&#xD;
          2. Pregnant women with a chronic illness were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant woman</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Semra Çevik, phD</last_name>
    <role>Study Director</role>
    <affiliation>University of Gaziantep</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gaziantep University</name>
      <address>
        <city>Gaziantep</city>
        <state>Şahinbey</state>
        <zip>27000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Mortazavi SH, Khaki S, Moradi R, Heidari K, Vasegh Rahimparvar SF. Effects of massage therapy and presence of attendant on pain, anxiety and satisfaction during labor. Arch Gynecol Obstet. 2012 Jul;286(1):19-23. doi: 10.1007/s00404-012-2227-4. Epub 2012 Jan 21.</citation>
    <PMID>22271239</PMID>
  </reference>
  <results_reference>
    <citation>Abbaspoor, Z., Mohammadkhani, S.L. (2013). Lavender aromatherapy massages in reducing labor pain and duration of labor: A randomized controlled trial. African Journal of Pharmacy and Pharmacology, 7(8): 426-430. DOI: 10.5897/AJPP12.391.</citation>
  </results_reference>
  <results_reference>
    <citation>Fenwick J, Staff L, Gamble J, Creedy DK, Bayes S. Why do women request caesarean section in a normal, healthy first pregnancy? Midwifery. 2010 Aug;26(4):394-400. doi: 10.1016/j.midw.2008.10.011. Epub 2008 Dec 30.</citation>
    <PMID>19117644</PMID>
  </results_reference>
  <results_reference>
    <citation>Field T. Pregnancy and labor massage. Expert Rev Obstet Gynecol. 2010 Mar;5(2):177-181. doi: 10.1586/eog.10.12.</citation>
    <PMID>20479957</PMID>
  </results_reference>
  <results_reference>
    <citation>Silva Gallo RB, Santana LS, Jorge Ferreira CH, Marcolin AC, Polineto OB, Duarte G, Quintana SM. Massage reduced severity of pain during labour: a randomised trial. J Physiother. 2013 Jun;59(2):109-16. doi: 10.1016/S1836-9553(13)70163-2.</citation>
    <PMID>23663796</PMID>
  </results_reference>
  <results_reference>
    <citation>Bolbol-Haghighi N, Masoumi SZ, Kazemi F. Effect of Massage Therapy on Duration of Labour: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Apr;10(4):QC12-5. doi: 10.7860/JCDR/2016/17447.7688. Epub 2016 Apr 1.</citation>
    <PMID>27190898</PMID>
  </results_reference>
  <results_reference>
    <citation>Hosseini SE, Bagheri M, Honarparvaran N. Investigating the effect of music on labor pain and progress in the active stage of first labor. Eur Rev Med Pharmacol Sci. 2013 Jun;17(11):1479-87.</citation>
    <PMID>23894767</PMID>
  </results_reference>
  <results_reference>
    <citation>Janssen P, Shroff F, Jaspar P. Massage therapy and labor outcomes: a randomized controlled trial. Int J Ther Massage Bodywork. 2012;5(4):15-20. doi: 10.3822/ijtmb.v5i4.164. Epub 2012 Dec 19. Erratum In: Int J Ther Massage Bodywork. 2013;6(1):25.</citation>
    <PMID>23429706</PMID>
  </results_reference>
  <results_reference>
    <citation>Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.</citation>
    <PMID>22419342</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Gaziantep</investigator_affiliation>
    <investigator_full_name>Semra Çevik, phD</investigator_full_name>
    <investigator_title>Assiatant Professor</investigator_title>
  </responsible_party>
  <keyword>anxiety</keyword>
  <keyword>labor pain</keyword>
  <keyword>massage</keyword>
  <keyword>surveys and questionnaires</keyword>
  <keyword>visual analog scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan: statistical analysis</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03755284/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03755284/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT03755284/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03755284
org study id: Sacral Massage
nct id: NCT03755284
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nonpharmacologic pain control methods, which are increasingly becoming widespread in coping
      with the labour pain, are the methods that allow women to completely relax without using any
      medication and direct them to perceive the pain at the lowest level. This study was conducted
      to determine the effect of sacral massage, on labour pain and anxiety. This study was
      conducted as a randomized controlled experimental study at Bağcılar Training and Research
      Hospital, Obstetrics and Gynecology Clinic between March and October 2016.

      Hypotheses of the Study

        1. Massage applied to the sacral region decreases the perception of a woman's labour pain.

        2. Massage applied to the sacral region decreases the woman's levels of concern and anxiety
           about labour.

        3. Massage applied to the sacral region increases the woman's satisfaction with the labour
Study design

      This was a randomized and controlled experimental study aimed to determine the effects of
      sacral massage on labour pain and anxiety.

      Setting and samples

      The study was performed in volunteer pregnant women who applied to xxx Training and Research
      Hospital, Delivery Unit, to undergo their first labour between January 25 and October 25,
      2016. This unit contains 1 delivery room (with 2 tables), 2 labour follow-up rooms (with 5
      beds), 1 postpartum room (with 5 beds) and 1 nursing room.

      According to hospital records, in all, 342 pregnant women who applied to xxx Training and
      Research Hospital, Delivery Unit to undergo their first labour between January 25 and October
      25, 2016, constituted the population of the study. The following inclusion criteria were used
      to determine participation in the study: (1) 19-40-year-old primiparous pregnant women;(2)
      Singleton pregnancies between 38-42 weeks; (3) Pregnant women whose labour began
      spontaneously; (4) Pregnant women with a healthy foetus; (5) Pregnant women without any
      complications that may cause dystocia during labour; (6) Pregnant women for whom analgesia
      and anaesthesia were not used during the first phase of labour; (7) Pregnant women who
      volunteered to participate in the research and who could establish verbal communication. In
      addition, Pregnant women with high-risk pregnancies, with caesarean section indication, and
      Pregnant women with a chronic illness were excluded.

      The sample size was calculated by Medical Faculty Biostatistics Department using Minitab
      Program. The sample volume to represent the population was determined as minimum 30 people
      for each group when considering comparison results of mean scores in the study of Field.,
      with a risk of α= 0.05, an accuracy rate of 1-α =0.95 and a power ratio of B= 0.20, 1-B=
      0.80.

      The study was conducted with two groups, namely Massage Group (experimental), and Control
      Group. 30 pregnant women were included in each group; therefore, the study was conducted with
      a total of 60 pregnant women. The women who participated in the study were randomized
      randomly as control (double) and experimental (single) groups according to the single or
      double patient admission numbers. The women who participated in the study were randomized
      into either the control (double) or the experimental (single) group according to single or
      double patient admission numbers.

      Measurements

      In this study, the Questionnaire form, Birth action follow-up form, postpartum interview form
      ,Visual analogue scale (VAS) and State-trait anxiety inventory (STAI FORM TX-I) were used to
      collect the data.

        1. Questionnaire Form: Questions that reflect the sociodemographic characteristics of the
           patients (age, educational status, social security, marital status), information about
           pregnancy (drugs used, status of their willingness to become pregnant, gestational week,
           status of attending examinations, status of collecting information about labour), the
           methods used to cope with the pain, and open-ended questions that evaluate the previous
           use of massage.

        2. Birth Action Follow-Up Form: The questions that indicate the length of the first phase,
           the interventions performed to shorten the first phase of labour, the methods used by
           the patient to cope with the labour pain, the emotional behaviours of the pregnant women
           during labour, the length of the second phase, adjustment of the pregnant women, the
           presence of intervention in labour, the status of episiotomy, the total duration of
           labour and the baby's health.

        3. Postpartum Interview Form: Open and closed questions that indicate the pregnant women's
           thoughts about labour, the status of overall satisfaction with labour and how the women
           feel were included in this form, which was prepared by a researcher in accordance with
           the relevant literature.

        4. Visual Analogue Scale (VAS): The Visual Analogue Scale (VAS) was used to measure the
           severity of labour pain. On this scale, numbers from 0 to 10 appear on a horizontal line
           of 100 mm. The pain level is expressed in figures that range from 0 to 10, as follows:
           the absence of pain is indicated by "0", while the most severe pain is indicated by
           "10". In this method, it is explained to the individual that there are two endpoints and
           that he/she is free to mark any point that defines his/her pain.

           The VAS was applied to the participants in the control group three times in the latent
           (3-4 cm), active (5-7 cm) and transition phases (8-10 cm) of labour. The VAS was also
           applied to those in the experimental group two times before and after the massage in
           each phase. The diagnosis was made in accordance with the subjective data including the
           patient's verbal expression.

        5. State-Trait Anxiety Inventory (STAI FORM TX-I): To determine state and trait anxiety
           levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was
           used. The individual is required to indicate the feelings or behaviours that he/she has
           experienced in a specific situation according to the degree of severity by marking one
           of the options such as (1) Never, (2) Little, (3) Very and (4) Completely. The
           state-trait anxiety inventory requires the individual to describe how he/she feels at a
           certain moment and under certain conditions by considering his/her feelings about a
           specific situation. While high scores indicate high anxiety levels, low scores indicate
           low anxiety levels. The state-trait anxiety inventory consists of 20 statements. The
           score obtained from the scale may vary between 20 and 80. While a high score represents
           a high anxiety level, a low score represents a low anxiety level. In the scoring
           performed in accordance with the criteria directive, 0-19 points are regarded as "none",
           20-39 points are regarded as "mild anxiety", 40-59 points are regarded as "moderate
           anxiety", 60-79 points are regarded as "heavy anxiety" and 80 points are regarded as
           "severe anxiety". In our study, the STAI FORM TX-I was used in the active (5-7 cm) phase
           in the control group and in the active (5-7 cm) phase after the massage in the
           experimental group to evaluate the anxiety experienced by women during labour.

      Data Collection

      After approval and permission to conduct the study were obtained from the ethics committee,
      the hospital's head nurse, delivery room charge nurse/midwife and other midwives and nurses
      were interviewed and informed about the purpose and scope of the study. Data were collected
      by one of the researchers. The researcher was aware of which patients were assigned to each
      group. However, the researchers did not interfere in any way with the study results. When
      they encountered women who met the inclusion criteria of the study, the purpose of the study
      was explained, and written consents were received from those who agreed to participate in the
      study. For the women who satisfied the criteria, participation in the study was voluntary.
      Additionally, during the study, no women requested to withdraw and no women were excluded
      from the study. Routine care and treatments for the women continued during data collection.

      Procedure

      Before the research data were collected, an informative meeting regarding the purpose and
      scope of the study was held for the members of the healthcare team who worked in the
      obstetrics and gynaecology clinic of the Turkish Republic Ministry of Health Public Hospitals
      Administration of Turkey, at the Istanbul Province xxx Training and Research Hospital, where
      the study would be conducted. In addition, cooperation was provided by the members of the
      healthcare team. For the correct application of the massage, the researcher was trained by
      the physical therapist who work at hospital. The massage was applied only to the pregnant
      women in the intervention group at every phase of labour. There was no intervention in the
      control group except for routine hospital applications. The steps taken in this study are
      discussed below.

      For the pregnant women included in the experimental group:

        -  One-on-one interviews were conducted with the pregnant women, and the voluntary
           disclosure forms, which explained the purpose of the study, were completed.

        -  The prepared questionnaire form was applied.

        -  In addition to providing them with routine nursing/midwifery care, the women in the
           experimental group were administered a massage to the sacral region under the
           supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and
           vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition
           (8-10 cm) phases of labour. To achieve this, the patients were placed in the left
           lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases
           of labour.

        -  The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated after the
           massage in the active (5-7 cm) phase.

        -  The Visual Analogue Scale (VAS) was evaluated once after the massage in the latent (3-4
           cm), active (5-7 cm) and transition (8-10 cm) phases.

        -  Birth action follow-up form and postpartum interview forms were applied.

      For the pregnant women included in the control group:

        -  One-on-one interviews were conducted with the pregnant women, and the voluntary
           disclosure forms, which explained the purpose of the study, were completed.

        -  The prepared questionnaire form was applied.

        -  Routine nursing/midwifery care was applied.

        -  The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated in the
           active (5-7 cm) phase.

        -  The Visual Analogue Scale (VAS) was evaluated once in the latent (3-4 cm), active (5-7
           cm) and transition (8-10 cm) phases.

        -  Birth action follow-up form and postpartum interview forms were applied One-on-one
           interviews were conducted with the women in both groups, and the voluntary disclosure
           forms, which explained the purpose of the study, were completed. After the prepared
           questionnaire form was applied to the women in the experimental group, routine
           nursing/midwifery care was provided.

      Data analysis

      In the evaluation of the data, in addition to descriptive statistical methods (e.g.,
      percentage, frequency, mean, and standard deviation), the chi-square test and Student's
      t-test were used in the comparison of the qualitative data. The results were evaluated at a
      significance level of p <0.05.

      The dependent variables of the study are the pain score averages of the pregnant women, the
      duration of the latent, active and transition phases of labour, and the anxiety level score.
      The independent variables of the study are the pregnant women's age, educational status,
      working status, and prenatal educational status, as well as the educational status of the
      husbands of the pregnant women, their willingness to become pregnant and the willingness to
      serve as controls before labour.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized and controlled experimental study
primary purpose: Treatment
masking: None (Open Label)
measure: The state-trait anxiety inventory (STAI FORM TX-I) evaluated
time frame: 6 hours
description: The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated after the massage in the active (5-7 cm) phase.To determine state and trait anxiety levels of the participants, the state-trait anxiety inventory (STAI FORM TX -I) was used. The individual is required to indicate the feelings or behaviours that he/she has experienced in a specific situation according to the degree of severity by marking one of the options such as (1) Never, (2) Little, (3) Very and (4) Completely.the STAI FORM TX-I was used in the active (5-7 cm) phase in the control group and in the active (5-7 cm) phase after the massage in the experimental group to evaluate the anxiety experienced by women during labour.
measure: The Visual Analogue Scale (VAS) evaluated
time frame: 6 hours
description: The Visual Analogue Scale (VAS) was used to measure the severity of labour pain. On this scale, numbers from 0 to 10 appear on a horizontal line of 100 mm. The pain level is expressed in figures that range from 0 to 10, as follows: the absence of pain is indicated by "0", while the most severe pain is indicated by "10". In this method, it is explained to the individual that there are two endpoints and that he/she is free to mark any point that defines his/her pain.The VAS was applied to the participants in the control group once in the latent (3-4 cm), active (5-7 cm) and transition phases (8-10 cm) of labour. The VAS was also applied to those in the experimental group once after the massage in each phase.
arm group label: sacral Massage Group
arm group type: Experimental
description: The massage was applied only to the pregnant women in the intervention group at every phase of labour. There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below.
For the pregnant women included in the experimental group:
In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.
arm group label: Control Group
arm group type: No Intervention
description: There was no intervention in the control group except for routine hospital applications. The steps taken in this study are discussed below.
One-on-one interviews were conducted with the pregnant women, and the voluntary disclosure forms, which explained the purpose of the study, were completed.
The prepared questionnaire form was applied. Routine nursing/midwifery care was applied. The state-trait anxiety inventory (STAI FORM TX-I) was applied and evaluated in the active (5-7 cm) phase.
The Visual Analogue Scale (VAS) was evaluated once in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases.
Birth action follow-up form and postpartum interview forms were applied
intervention type: Other
intervention name: Sacral Massage
description: ● In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.
arm group label: sacral Massage Group
criteria: 
gender: Female
gender based: Yes
gender description: pregnant woman
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Semra Çevik, phD
role: Study Director
affiliation: University of Gaziantep
facility: 
country: Turkey
citation: Mortazavi SH, Khaki S, Moradi R, Heidari K, Vasegh Rahimparvar SF. Effects of massage therapy and presence of attendant on pain, anxiety and satisfaction during labor. Arch Gynecol Obstet. 2012 Jul;286(1):19-23. doi: 10.1007/s00404-012-2227-4. Epub 2012 Jan 21.
PMID: 22271239
citation: Abbaspoor, Z., Mohammadkhani, S.L. (2013). Lavender aromatherapy massages in reducing labor pain and duration of labor: A randomized controlled trial. African Journal of Pharmacy and Pharmacology, 7(8): 426-430. DOI: 10.5897/AJPP12.391.
citation: Fenwick J, Staff L, Gamble J, Creedy DK, Bayes S. Why do women request caesarean section in a normal, healthy first pregnancy? Midwifery. 2010 Aug;26(4):394-400. doi: 10.1016/j.midw.2008.10.011. Epub 2008 Dec 30.
PMID: 19117644
citation: Field T. Pregnancy and labor massage. Expert Rev Obstet Gynecol. 2010 Mar;5(2):177-181. doi: 10.1586/eog.10.12.
PMID: 20479957
citation: Silva Gallo RB, Santana LS, Jorge Ferreira CH, Marcolin AC, Polineto OB, Duarte G, Quintana SM. Massage reduced severity of pain during labour: a randomised trial. J Physiother. 2013 Jun;59(2):109-16. doi: 10.1016/S1836-9553(13)70163-2.
PMID: 23663796
citation: Bolbol-Haghighi N, Masoumi SZ, Kazemi F. Effect of Massage Therapy on Duration of Labour: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Apr;10(4):QC12-5. doi: 10.7860/JCDR/2016/17447.7688. Epub 2016 Apr 1.
PMID: 27190898
citation: Hosseini SE, Bagheri M, Honarparvaran N. Investigating the effect of music on labor pain and progress in the active stage of first labor. Eur Rev Med Pharmacol Sci. 2013 Jun;17(11):1479-87.
PMID: 23894767
citation: Janssen P, Shroff F, Jaspar P. Massage therapy and labor outcomes: a randomized controlled trial. Int J Ther Massage Bodywork. 2012;5(4):15-20. doi: 10.3822/ijtmb.v5i4.164. Epub 2012 Dec 19. Erratum In: Int J Ther Massage Bodywork. 2013;6(1):25.
PMID: 23429706
citation: Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
PMID: 22419342
responsible party type: Sponsor-Investigator
investigator affiliation: University of Gaziantep
investigator full name: Semra Çevik, phD
investigator title: Assiatant Professor
mesh term: Labor Pain
sharing ipd: No
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