xml: <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/NCT05962918</url>
    </required_header>
    <id_info>
      <org_study_id>habibe4721</org_study_id>
      <nct_id>NCT05962918</nct_id>
    </id_info>
    <brief_title>Perineal Massage Performed During the Labour</brief_title>
    <official_title>The Effects of Perineal Massage Performed During Labor on Childbirth Comfort, Perineal Pain and Trauma in Nulliparous Women: A Quasi Experimental Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Munzur University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Munzur University</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>
        In this study, perineal massage was applied to primiparous women who did not give birth&#xD;
        before, as a quasi-experimental control group to determine the effects of massage on birth&#xD;
        comfort, perineal trauma and perineal pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, perineal massage was applied to primiparous women who did not give birth&#xD;
        before, as a quasi-experimental control group to determine the effects of massage on birth&#xD;
        comfort, perineal trauma and perineal pain. Perineal massage was administered to all pregnant&#xD;
        women in the experimental group during both the labor and resting phases between&#xD;
        contractions. The participants received an average of 5-10 minutes of perineal massage two,&#xD;
        four and four to six times at the latent (0-3-cm cervical dilation), active (4-7-cm cervical&#xD;
        dilation) and transition (8-10-cm cervical dilation) phases of labor, respectively. These&#xD;
        women continued to receive perineal massage at every push throughout the second stage of&#xD;
        labor. Before perineal massage, the researcher wore sterile gloves, placed two fingers into&#xD;
        the 3-4-cm wide-open vagina and applied Vaseline routinely to lubricate the vagina in the&#xD;
        delivery room. . Perineal massage was applied using all three of the &quot;from one edge to the&#xD;
        other&quot;, &quot;U shape&quot; and &quot;pressure&quot; massage techniques. The researcher gently applied a rhythmic&#xD;
        &quot;U&quot; pressure with both fingers, moving them on the vagina downwards about 3 to 9 o'clock.&#xD;
        Each pressure movement was maintained laterally for 1-2 minutes towards the rectum.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2018</start_date>
    <completion_date type="Actual">April 1, 2019</completion_date>
    <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Paralel designed non randomized two armed study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Since the researcher did the intervention and analysis, only the participants did not know which group they were in, so single blinding was done.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in perineal pain scores</measure>
      <time_frame>4-6 hours after the childbirth</time_frame>
      <description>The mean visual analog scale (VAS) scores of the pregnant women in the experimental and control groups were compared to determine the level of perineal pain. Women were asked to rate pain from zero to 10. A score of zero means no pain, while 10 = indicates the most severe pain experienced.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in childbirth comfort scores</measure>
      <time_frame>4-6 hours after coming to labor</time_frame>
      <description>The &quot;Childbirth Comfort Questionnaire (CCQ)&quot; score averages were compared to determine the birth comfort levels of the pregnant women in the experimental and control groups. As the score increases, high-level comfort is mentioned, as the score decreases, low-level comfort is mentioned. The lowest and highest possible total scale scores are 9 and 45.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in perineal trauma scores</measure>
      <time_frame>4-6 hours after the childbirth.</time_frame>
      <description>The REEDA scale mean scores were compared to determine the perineal trauma levels of the women in the experimental and control groups. The REEDA scale, consists of five variables of wound healing. These variables are redness, edema, ecchymosis, discharge and approximation of the wound edges. The scale items are scored between 0 and 3 points. The lowest and highest possible total scale scores are 0 and 15. A higher score indicates a greater level of perineal trauma.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">182</enrollment>
    <condition>Delivery Problem</condition>
    <condition>Childrearing</condition>
    <condition>Satisfaction, Patient</condition>
    <condition>Perineum; Injury</condition>
    <condition>Perineal Tear</condition>
    <condition>Pain, Labor</condition>
    <arm_group>
      <arm_group_label>perineal massage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>intervention group with perineal massage</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The group that received routine hospital protocol and was not massaged.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Perinal massage</intervention_name>
      <description>Perineal massage was administered to all pregnant women in the experimental group during both the labor and resting phases between contractions. The participants received an average of 5-10 minutes of perineal massage two, four and four to six times at the latent (0-3-cm cervical dilation), active (4-7-cm cervical dilation) and transition (8-10-cm cervical dilation) phases of labor, respectively. These women continued to receive perineal massage at every push throughout the second stage of labor. The researcher midwife gently widened the perineal muscles by making stretching movements with her fingers. Perineal massage was applied using all three of the &quot;from one edge to the other&quot;, &quot;U shape&quot; and &quot;pressure&quot; massage techniques. The researcher gently applied a rhythmic &quot;U&quot; pressure with both fingers, moving them on the vagina downwards about 3 to 9 o'clock. Each pressure movement was maintained laterally for 1-2 minutes towards the rectum.</description>
      <arm_group_label>perineal massage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having no complications for vaginal delivery&#xD;
  &#xD;
            -  Having no dystocia affecting the birth process (e.g., prolonged labor, precipitate&#xD;
               labor, shoulder dystocia)&#xD;
  &#xD;
            -  Having a singleton pregnancy,&#xD;
  &#xD;
            -  Having a fetal head with an anterior cephalic position,&#xD;
  &#xD;
            -  Being at the latent phase of labor,&#xD;
  &#xD;
            -  Having no perineal scar tissue,&#xD;
  &#xD;
            -  Having no diagnosis of vaginal fungus or infection,&#xD;
  &#xD;
            -  Having a fetus with a birth weight between 2500 and 4000 g,&#xD;
  &#xD;
            -  Having no communication problems.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -All pregnant women who developed fetal distress during labor or had to undergo cesarean&#xD;
          delivery were excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Munzur University</name>
        <address>
          <city>Tunceli</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/29238501/</url>
      <description>Related Info</description>
    </link>
    <reference>
      <citation>Labrecque M, Eason E, Marcoux S, Lemieux F, Pinault JJ, Feldman P, Laperriere L. Randomized controlled trial of prevention of perineal trauma by perineal massage during pregnancy. Am J Obstet Gynecol. 1999 Mar;180(3 Pt 1):593-600. doi: 10.1016/s0002-9378(99)70260-7.</citation>
      <PMID>10076134</PMID>
    </reference>
    <reference>
      <citation>Aquino CI, Guida M, Saccone G, Cruz Y, Vitagliano A, Zullo F, Berghella V. Perineal massage during labor: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2020 Mar;33(6):1051-1063. doi: 10.1080/14767058.2018.1512574. Epub 2018 Sep 19.</citation>
      <PMID>30107756</PMID>
    </reference>
    <reference>
      <citation>Karacam Z, Ekmen H, Calisir H. The use of perineal massage in the second stage of labor and follow-up of postpartum perineal outcomes. Health Care Women Int. 2012;33(8):697-718. doi: 10.1080/07399332.2012.655385.</citation>
      <PMID>22827728</PMID>
    </reference>
    <reference>
      <citation>Williams A, Herron-Marx S, Knibb R. The prevalence of enduring postnatal perineal morbidity and its relationship to type of birth and birth risk factors. J Clin Nurs. 2007 Mar;16(3):549-61. doi: 10.1111/j.1365-2702.2006.01593.x.</citation>
      <PMID>17335531</PMID>
    </reference>
    <reference>
      <citation>Kalichman L. Perineal massage to prevent perineal trauma in childbirth. Isr Med Assoc J. 2008 Jul;10(7):531-3. No abstract available.</citation>
      <PMID>18751635</PMID>
    </reference>
    <reference>
      <citation>Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.</citation>
      <PMID>21614497</PMID>
    </reference>
    <results_reference>
      <citation>Akhlaghi F, Sabeti Baygi Z, Miri M, Najaf Najafi M. Effect of Perineal Massage on the Rate of Episiotomy. J Family Reprod Health. 2019 Sep;13(3):160-166.</citation>
      <PMID>32201491</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Munzur University</investigator_affiliation>
      <investigator_full_name>Habibe YAŞAR YETİŞMİŞ</investigator_full_name>
      <investigator_title>Research assistant, Phd Student</investigator_title>
    </responsible_party>
    <keyword>Childbirth comfort</keyword>
    <keyword>Perineal massage</keyword>
    <keyword>Perineal tear</keyword>
    <keyword>Perineal pain</keyword>
    <keyword>midwifery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dystocia</mesh_term>
      <mesh_term>Labor Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962918
  org study id: habibe4721
  nct id: NCT05962918
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, perineal massage was applied to primiparous women who did not give birth
        before, as a quasi-experimental control group to determine the effects of massage on birth
        comfort, perineal trauma and perineal pain.
  In this study, perineal massage was applied to primiparous women who did not give birth
        before, as a quasi-experimental control group to determine the effects of massage on birth
        comfort, perineal trauma and perineal pain. Perineal massage was administered to all pregnant
        women in the experimental group during both the labor and resting phases between
        contractions. The participants received an average of 5-10 minutes of perineal massage two,
        four and four to six times at the latent (0-3-cm cervical dilation), active (4-7-cm cervical
        dilation) and transition (8-10-cm cervical dilation) phases of labor, respectively. These
        women continued to receive perineal massage at every push throughout the second stage of
        labor. Before perineal massage, the researcher wore sterile gloves, placed two fingers into
        the 3-4-cm wide-open vagina and applied Vaseline routinely to lubricate the vagina in the
        delivery room. . Perineal massage was applied using all three of the "from one edge to the
        other", "U shape" and "pressure" massage techniques. The researcher gently applied a rhythmic
        "U" pressure with both fingers, moving them on the vagina downwards about 3 to 9 o'clock.
        Each pressure movement was maintained laterally for 1-2 minutes towards the rectum.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Paralel designed non randomized two armed study
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: Since the researcher did the intervention and analysis, only the participants did not know which group they were in, so single blinding was done.
  measure: Change in perineal pain scores
  time frame: 4-6 hours after the childbirth
  description: The mean visual analog scale (VAS) scores of the pregnant women in the experimental and control groups were compared to determine the level of perineal pain. Women were asked to rate pain from zero to 10. A score of zero means no pain, while 10 = indicates the most severe pain experienced.
  measure: Change in childbirth comfort scores
  time frame: 4-6 hours after coming to labor
  description: The "Childbirth Comfort Questionnaire (CCQ)" score averages were compared to determine the birth comfort levels of the pregnant women in the experimental and control groups. As the score increases, high-level comfort is mentioned, as the score decreases, low-level comfort is mentioned. The lowest and highest possible total scale scores are 9 and 45.
  measure: Change in perineal trauma scores
  time frame: 4-6 hours after the childbirth.
  description: The REEDA scale mean scores were compared to determine the perineal trauma levels of the women in the experimental and control groups. The REEDA scale, consists of five variables of wound healing. These variables are redness, edema, ecchymosis, discharge and approximation of the wound edges. The scale items are scored between 0 and 3 points. The lowest and highest possible total scale scores are 0 and 15. A higher score indicates a greater level of perineal trauma.
  arm group label: perineal massage
  arm group type: Experimental
  description: intervention group with perineal massage
  arm group label: control group
  arm group type: No Intervention
  description: The group that received routine hospital protocol and was not massaged.
  intervention type: Other
  intervention name: Perinal massage
  description: Perineal massage was administered to all pregnant women in the experimental group during both the labor and resting phases between contractions. The participants received an average of 5-10 minutes of perineal massage two, four and four to six times at the latent (0-3-cm cervical dilation), active (4-7-cm cervical dilation) and transition (8-10-cm cervical dilation) phases of labor, respectively. These women continued to receive perineal massage at every push throughout the second stage of labor. The researcher midwife gently widened the perineal muscles by making stretching movements with her fingers. Perineal massage was applied using all three of the "from one edge to the other", "U shape" and "pressure" massage techniques. The researcher gently applied a rhythmic "U" pressure with both fingers, moving them on the vagina downwards about 3 to 9 o'clock. Each pressure movement was maintained laterally for 1-2 minutes towards the rectum.
  arm group label: perineal massage
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  url: https://pubmed.ncbi.nlm.nih.gov/29238501/
  description: Related Info
  citation: Labrecque M, Eason E, Marcoux S, Lemieux F, Pinault JJ, Feldman P, Laperriere L. Randomized controlled trial of prevention of perineal trauma by perineal massage during pregnancy. Am J Obstet Gynecol. 1999 Mar;180(3 Pt 1):593-600. doi: 10.1016/s0002-9378(99)70260-7.
  PMID: 10076134
  citation: Aquino CI, Guida M, Saccone G, Cruz Y, Vitagliano A, Zullo F, Berghella V. Perineal massage during labor: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2020 Mar;33(6):1051-1063. doi: 10.1080/14767058.2018.1512574. Epub 2018 Sep 19.
  PMID: 30107756
  citation: Karacam Z, Ekmen H, Calisir H. The use of perineal massage in the second stage of labor and follow-up of postpartum perineal outcomes. Health Care Women Int. 2012;33(8):697-718. doi: 10.1080/07399332.2012.655385.
  PMID: 22827728
  citation: Williams A, Herron-Marx S, Knibb R. The prevalence of enduring postnatal perineal morbidity and its relationship to type of birth and birth risk factors. J Clin Nurs. 2007 Mar;16(3):549-61. doi: 10.1111/j.1365-2702.2006.01593.x.
  PMID: 17335531
  citation: Kalichman L. Perineal massage to prevent perineal trauma in childbirth. Isr Med Assoc J. 2008 Jul;10(7):531-3. No abstract available.
  PMID: 18751635
  citation: Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.
  PMID: 21614497
  citation: Akhlaghi F, Sabeti Baygi Z, Miri M, Najaf Najafi M. Effect of Perineal Massage on the Rate of Episiotomy. J Family Reprod Health. 2019 Sep;13(3):160-166.
  PMID: 32201491
  responsible party type: Principal Investigator
  investigator affiliation: Munzur University
  investigator full name: Habibe YAŞAR YETİŞMİŞ
  investigator title: Research assistant, Phd Student
  mesh term: Dystocia
  mesh term: Labor Pain
  sharing ipd: No