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/NCT06024811</url>
    </required_header>
    <id_info>
      <org_study_id>Balikesir</org_study_id>
      <nct_id>NCT06024811</nct_id>
    </id_info>
    <brief_title>Investigation of the Effect of Supporting Nursing Care Provided in Line With During Intrapartum Period</brief_title>
    <acronym>Support</acronym>
    <official_title>Investigation of the Effect of Supporting Nursing Care Provided in Line With Evidence-Based Practices During Intrapartum Period</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Balikesir University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Balikesir University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Aim: The aim of the research was to examine the effect of supportive nursing care provided in&#xD;
        line with evidence-based practices during the intrapartum period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Methods Design and Settings This study with intervention-control group, randomized and&#xD;
        intervention type was carried out in a hospital in Balikesir, located in the west of Turkiye.&#xD;
  &#xD;
        Hypotheses Hypothesis 1: Supportive nursing care provided in line with evidence-based&#xD;
        practices during the intrapartum period has an effect on the state anxiety level of women.&#xD;
  &#xD;
        Hypothesis 2: Supportive nursing care provided in line with evidence-based practices during&#xD;
        the intrapartum period has an effect on perceived labor pain.&#xD;
  &#xD;
        Hypothesis 3: Supportive nursing care provided in the intrapartum period in line with&#xD;
        evidence-based practices has an effect on the duration on birth.&#xD;
  &#xD;
        Hypothesis 4: Supportive nursing care provided in line with evidence-based practices in the&#xD;
        intrapartum period has an effect on maternal satisfaction.&#xD;
  &#xD;
        Universe and sample of the research&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 3, 2020</start_date>
    <completion_date type="Actual">February 15, 2021</completion_date>
    <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>positive birth</measure>
      <time_frame>2020-2021</time_frame>
      <description>The positive birth highlights the importance of woman-centred care to optimize the experience of labour and childbirth for women and their babies through a holistic, human rights-based approach.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">1</enrollment>
    <condition>Delivery;Breech;Stillbirth</condition>
    <arm_group>
      <arm_group_label>intervention</arm_group_label>
      <description>Pregnant women over 18 years of age, with cervical dilatation 3 cm or more, planned for spontaneous vaginal delivery, term and singleton pregnancy, who speak Turkish, who did not have language communication problems, and who voluntarily agreed to participate in the study were included.&#xD;
  Pregnant women in the intervention and control groups were randomized using the &quot;www.random.org website&quot; on the computer (intervention=56 control= 56).Intervention and control groups were randomized according to some basic variables (age group, education level, body mass index, number of births and pregnancies, participation in prenatal preparation classes) considering the literature .</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <description>Pregnant women over 18 years of age, with cervical dilatation 3 cm or more, planned for spontaneous vaginal delivery, term and singleton pregnancy, who speak Turkish, who did not have language communication problems, and who voluntarily agreed to participate in the study were included.&#xD;
  During the data collection period of the study, 313 women were evaluated according to the inclusion and exclusion criteria. Women who did not meet the inclusion criteria (n=198) and refused to participate in the study (n=3) were not included in the study sample. Pregnant women in the intervention and control groups were randomized using the &quot;www.random.org website&quot; on the computer (intervention=56 control= 56).Intervention and control groups were randomized according to some basic variables (age group, education level, body mass index, number of births and pregnancies, participation in prenatal preparation classes) considering the literature (Taghenijad et al. 2010; Erdogan et al. 2017).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>supporting nursing care</intervention_name>
      <description>Supportive nursing care was applied during the intrapartum period. Latent Active Transition phase,birt, postpartum period</description>
      <arm_group_label>intervention</arm_group_label>
      <other_name>Supportive nursing care practices in the latent phase Types of supportive care Physical Emotional Informational Advocacy Partner</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The universe of the research consisted of pregnant women who applied to the delivery unit&#xD;
          of a hospital to give birth in Balıkesir, Turkiye. A total of 4634 deliveries took place in&#xD;
          this hospital in 2019, of which 2315 were normal deliveries.&#xD;
          (https://balikesirism.saglik.gov.tr/ accessed on 2021 Aug 18). The sample size in the study&#xD;
          was calculated with the G*power 3.1.9.2 program. Since the scores will be compared in the&#xD;
          two dependent groups before and after the intervention, the minimum sample size was&#xD;
          calculated as 54, 27 people in each group, based on the two-way hypothesis, 5% type I&#xD;
          error, 0.50 Cohen's effect size, and 95% power&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women over 18 years of age,&#xD;
  &#xD;
            -  with cervical dilatation 3 cm or more,&#xD;
  &#xD;
            -  Planned for spontaneous vaginal delivery,&#xD;
  &#xD;
            -  Term and singleton pregnancy,&#xD;
  &#xD;
            -  Who speak Turkish, who did not have language communication problems,&#xD;
  &#xD;
            -  Who voluntarily agreed to participate in the study were included&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women with head-pelvis incompatibility&#xD;
  &#xD;
            -  Those who gave birth by cesarean section before&#xD;
  &#xD;
            -  Pregnant women planned for cesarean delivery&#xD;
  &#xD;
            -  Pregnant women with any systemic disease (Diabetes mellitus, hypertension, etc.)&#xD;
  &#xD;
            -  Pregnant women who develop fetal distress or hypoxia during labor)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Pregnant women over 18 years of age.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ESRA ÇEVİK</last_name>
      <role>Principal Investigator</role>
      <affiliation>https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Balıkesir University</name>
        <address>
          <city>Balıkesir</city>
          <state>Altıeylül</state>
          <zip>10100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Barrett SJ, Stark MA. Factors associated with labor support behaviors of nurses. J Perinat Educ. 2010 Winter;19(1):12-8. doi: 10.1624/105812410X481528.</citation>
      <PMID>21197128</PMID>
    </reference>
    <reference>
      <citation>Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.</citation>
      <PMID>28681500</PMID>
    </reference>
    <reference>
      <citation>Cicek S, Basar F. The effects of breathing techniques training on the duration of labor and anxiety levels of pregnant women. Complement Ther Clin Pract. 2017 Nov;29:213-219. doi: 10.1016/j.ctcp.2017.10.006. Epub 2017 Oct 18.</citation>
      <PMID>29122264</PMID>
    </reference>
    <reference>
      <citation>Debeb Sendekie A, Belay MA, Ayalew Yimer S, Degu Ayele A. Evidence-Based Intrapartum Practice and Associated Factors Among Obstetric Care Providers Working in Public Hospitals of South Wollo Zone North-Central Ethiopia: An Institutional-Based Cross-Sectional Study. Int J Womens Health. 2022 May 19;14:719-730. doi: 10.2147/IJWH.S351795. eCollection 2022.</citation>
      <PMID>35615384</PMID>
    </reference>
    <reference>
      <citation>Gams B, Neerland C, Kennedy S. Reducing Primary Cesareans: An Innovative Multipronged Approach to Supporting Physiologic Labor and Vaginal Birth. J Perinat Neonatal Nurs. 2019 Jan/Mar;33(1):52-60. doi: 10.1097/JPN.0000000000000378.</citation>
      <PMID>30676462</PMID>
    </reference>
    <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>
    </reference>
    <reference>
      <citation>Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003766. doi: 10.1002/14651858.CD003766.pub2.</citation>
      <PMID>17636733</PMID>
    </reference>
    <reference>
      <citation>Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003766. doi: 10.1002/14651858.CD003766.pub4.</citation>
      <PMID>23076901</PMID>
    </reference>
    <reference>
      <citation>Kobayashi S, Hanada N, Matsuzaki M, Takehara K, Ota E, Sasaki H, Nagata C, Mori R. Assessment and support during early labour for improving birth outcomes. Cochrane Database Syst Rev. 2017 Apr 20;4(4):CD011516. doi: 10.1002/14651858.CD011516.pub2.</citation>
      <PMID>28426160</PMID>
    </reference>
    <reference>
      <citation>Nikula P, Laukkala H, Polkki T. Mothers' Perceptions of Labor Support. MCN Am J Matern Child Nurs. 2015 Nov-Dec;40(6):373-80. doi: 10.1097/NMC.0000000000000190.</citation>
      <PMID>26275315</PMID>
    </reference>
    <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>
    <reference>
      <citation>Smith CA, Levett KM, Collins CT, Dahlen HG, Ee CC, Suganuma M. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009290. doi: 10.1002/14651858.CD009290.pub3.</citation>
      <PMID>29589380</PMID>
    </reference>
    <reference>
      <citation>Weeks F, Pantoja L, Ortiz J, Foster J, Cavada G, Binfa L. Labor and Birth Care Satisfaction Associated With Medical Interventions and Accompaniment During Labor Among Chilean Women. J Midwifery Womens Health. 2017 Mar;62(2):196-203. doi: 10.1111/jmwh.12499. Epub 2016 Aug 20.</citation>
      <PMID>27543442</PMID>
    </reference>
    <reference>
      <citation>Wanyenze EW, Nalwadda GK, Byamugisha JK, Muwanguzi PA, Tumwesigye NM. Effect of Midwife-Provided Orientation of Birth Companions on Maternal Anxiety and Coping during Labor: A Stepped Wedge Cluster Randomized Control Trial in Eastern Uganda. Int J Environ Res Public Health. 2023 Jan 14;20(2):1549. doi: 10.3390/ijerph20021549.</citation>
      <PMID>36674304</PMID>
    </reference>
    <results_reference>
      <citation>Dai XW. [Scanning electron microscopy of gallstone matrix]. Zhonghua Wai Ke Za Zhi. 1983 Jun;21(6):326-7. No abstract available. Chinese.</citation>
      <PMID>6641424</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Balikesir University</investigator_affiliation>
      <investigator_full_name>Esra Cevik</investigator_full_name>
      <investigator_title>Assist Prof.</investigator_title>
    </responsible_party>
    <keyword>supportive nursing care</keyword>
    <keyword>state anxiety.</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stillbirth</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/NCT06024811
  org study id: Balikesir
  nct id: NCT06024811
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Aim: The aim of the research was to examine the effect of supportive nursing care provided in
        line with evidence-based practices during the intrapartum period.
  Methods Design and Settings This study with intervention-control group, randomized and
        intervention type was carried out in a hospital in Balikesir, located in the west of Turkiye.
  
        Hypotheses Hypothesis 1: Supportive nursing care provided in line with evidence-based
        practices during the intrapartum period has an effect on the state anxiety level of women.
  
        Hypothesis 2: Supportive nursing care provided in line with evidence-based practices during
        the intrapartum period has an effect on perceived labor pain.
  
        Hypothesis 3: Supportive nursing care provided in the intrapartum period in line with
        evidence-based practices has an effect on the duration on birth.
  
        Hypothesis 4: Supportive nursing care provided in line with evidence-based practices in the
        intrapartum period has an effect on maternal satisfaction.
  
        Universe and sample of the research
  observational model: Case-Control
  time perspective: Prospective
  measure: positive birth
  time frame: 2020-2021
  description: The positive birth highlights the importance of woman-centred care to optimize the experience of labour and childbirth for women and their babies through a holistic, human rights-based approach.
  arm group label: intervention
  description: Pregnant women over 18 years of age, with cervical dilatation 3 cm or more, planned for spontaneous vaginal delivery, term and singleton pregnancy, who speak Turkish, who did not have language communication problems, and who voluntarily agreed to participate in the study were included.
  Pregnant women in the intervention and control groups were randomized using the "www.random.org website" on the computer (intervention=56 control= 56).Intervention and control groups were randomized according to some basic variables (age group, education level, body mass index, number of births and pregnancies, participation in prenatal preparation classes) considering the literature .
  arm group label: control
  description: Pregnant women over 18 years of age, with cervical dilatation 3 cm or more, planned for spontaneous vaginal delivery, term and singleton pregnancy, who speak Turkish, who did not have language communication problems, and who voluntarily agreed to participate in the study were included.
  During the data collection period of the study, 313 women were evaluated according to the inclusion and exclusion criteria. Women who did not meet the inclusion criteria (n=198) and refused to participate in the study (n=3) were not included in the study sample. Pregnant women in the intervention and control groups were randomized using the "www.random.org website" on the computer (intervention=56 control= 56).Intervention and control groups were randomized according to some basic variables (age group, education level, body mass index, number of births and pregnancies, participation in prenatal preparation classes) considering the literature (Taghenijad et al. 2010; Erdogan et al. 2017).
  intervention type: Behavioral
  intervention name: supporting nursing care
  description: Supportive nursing care was applied during the intrapartum period. Latent Active Transition phase,birt, postpartum period
  arm group label: intervention
  other name: Supportive nursing care practices in the latent phase Types of supportive care Physical Emotional Informational Advocacy Partner
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Pregnant women over 18 years of age.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: ESRA ÇEVİK
  role: Principal Investigator
  affiliation: https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
  facility: 
  country: Turkey
  citation: Barrett SJ, Stark MA. Factors associated with labor support behaviors of nurses. J Perinat Educ. 2010 Winter;19(1):12-8. doi: 10.1624/105812410X481528.
  PMID: 21197128
  citation: Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.
  PMID: 28681500
  citation: Cicek S, Basar F. The effects of breathing techniques training on the duration of labor and anxiety levels of pregnant women. Complement Ther Clin Pract. 2017 Nov;29:213-219. doi: 10.1016/j.ctcp.2017.10.006. Epub 2017 Oct 18.
  PMID: 29122264
  citation: Debeb Sendekie A, Belay MA, Ayalew Yimer S, Degu Ayele A. Evidence-Based Intrapartum Practice and Associated Factors Among Obstetric Care Providers Working in Public Hospitals of South Wollo Zone North-Central Ethiopia: An Institutional-Based Cross-Sectional Study. Int J Womens Health. 2022 May 19;14:719-730. doi: 10.2147/IJWH.S351795. eCollection 2022.
  PMID: 35615384
  citation: Gams B, Neerland C, Kennedy S. Reducing Primary Cesareans: An Innovative Multipronged Approach to Supporting Physiologic Labor and Vaginal Birth. J Perinat Neonatal Nurs. 2019 Jan/Mar;33(1):52-60. doi: 10.1097/JPN.0000000000000378.
  PMID: 30676462
  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: Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003766. doi: 10.1002/14651858.CD003766.pub2.
  PMID: 17636733
  citation: Hodnett ED, Gates S, Hofmeyr GJ, Sakala C. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003766. doi: 10.1002/14651858.CD003766.pub4.
  PMID: 23076901
  citation: Kobayashi S, Hanada N, Matsuzaki M, Takehara K, Ota E, Sasaki H, Nagata C, Mori R. Assessment and support during early labour for improving birth outcomes. Cochrane Database Syst Rev. 2017 Apr 20;4(4):CD011516. doi: 10.1002/14651858.CD011516.pub2.
  PMID: 28426160
  citation: Nikula P, Laukkala H, Polkki T. Mothers' Perceptions of Labor Support. MCN Am J Matern Child Nurs. 2015 Nov-Dec;40(6):373-80. doi: 10.1097/NMC.0000000000000190.
  PMID: 26275315
  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: Smith CA, Levett KM, Collins CT, Dahlen HG, Ee CC, Suganuma M. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009290. doi: 10.1002/14651858.CD009290.pub3.
  PMID: 29589380
  citation: Weeks F, Pantoja L, Ortiz J, Foster J, Cavada G, Binfa L. Labor and Birth Care Satisfaction Associated With Medical Interventions and Accompaniment During Labor Among Chilean Women. J Midwifery Womens Health. 2017 Mar;62(2):196-203. doi: 10.1111/jmwh.12499. Epub 2016 Aug 20.
  PMID: 27543442
  citation: Wanyenze EW, Nalwadda GK, Byamugisha JK, Muwanguzi PA, Tumwesigye NM. Effect of Midwife-Provided Orientation of Birth Companions on Maternal Anxiety and Coping during Labor: A Stepped Wedge Cluster Randomized Control Trial in Eastern Uganda. Int J Environ Res Public Health. 2023 Jan 14;20(2):1549. doi: 10.3390/ijerph20021549.
  PMID: 36674304
  citation: Dai XW. [Scanning electron microscopy of gallstone matrix]. Zhonghua Wai Ke Za Zhi. 1983 Jun;21(6):326-7. No abstract available. Chinese.
  PMID: 6641424
  responsible party type: Principal Investigator
  investigator affiliation: Balikesir University
  investigator full name: Esra Cevik
  investigator title: Assist Prof.
  mesh term: Stillbirth
  sharing ipd: No