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/NCT06035172</url>
    </required_header>
    <id_info>
      <org_study_id>2022/362</org_study_id>
      <nct_id>NCT06035172</nct_id>
    </id_info>
    <brief_title>The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience</brief_title>
    <official_title>The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul University - Cerrahpasa (IUC)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Purpose: The aim of this project is to examine the effects of guided imagery and music&#xD;
        performance during labor on labor pain, anxiety and birth experience.&#xD;
  &#xD;
        Methods: The research to be carried out within the scope of the project is randomized&#xD;
        controlled and has an experimental research design. The population of the research consists&#xD;
        of primiparous pregnant women who applied to the Istanbul Provincial Health Directorate,&#xD;
        Istanbul Training and Research Hospital, Suleymaniye Obstetrics and Pediatrics Additional&#xD;
        Service Building, Birth Unit. Eligible participants in the study sample will be randomly&#xD;
        selected at a 1:1:1 ratio. In the calculation of the sample size, using the G*Power (3.1.9.2)&#xD;
        program, 5% first type error, 0.30 standardized effect size, distribution ratio to 1 groups,&#xD;
        90% power considering data loss, and the minimum sample size required for 3 groups was 144&#xD;
        people in total. calculated as 48 cases for each group. The group of pregnant women who meet&#xD;
        the inclusion criteria will be determined by using the &quot;Randomizer.org&quot; program. In this&#xD;
        direction, 48 people (guided imagery) should be included in experiment 1, 48 people in&#xD;
        experiment 2 (musical concert) and 48 people in control group. &quot;Informed Consent Form&quot; and&#xD;
        &quot;Voluntary Consent Form&quot; will be presented to the pregnant women included in the study, by&#xD;
        giving information about the study.&quot;Personal Information Form&quot;, &quot;Visual Analogue Scale&#xD;
        (VAS)&quot;, &quot;State Trait Anxiety Scale (STAI Form TX-1)&quot; and &quot;Birth Expectations and Experiences&#xD;
        Scale-Part 1 (DBSS-1)&quot; will be applied to pregnant women assigned to the Guided Imagery&#xD;
        Group. . In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7&#xD;
        cm and 8-10 cm, a 15-minute guided imagery concert (of the scenario determined for the birth&#xD;
        process) prepared by the researchers within the scope of the literature, with the service of&#xD;
        a ney artist and a psychological counselor, is played by bluetooth from an MP3 player. The&#xD;
        pregnant woman will be listened to by the researcher through headphones. &quot;VAS&quot; will be&#xD;
        applied after each attempt. 1 hour after the birth of the baby and placenta, data will be&#xD;
        collected by applying &quot;VAS&quot;, &quot;STAI Form TX-1&quot; and &quot;Birth Expectations and Experiences&#xD;
        Scale-Part 2 (DBSS-2)&quot;.&#xD;
  &#xD;
        &quot;Personal Information Form&quot;, &quot;VAS&quot;, &quot;STAI Form TX-1&quot; and &quot;DBSS-1&quot; will be applied to pregnant&#xD;
        women assigned to the music concert group. In the active phase of labor, when the cervical&#xD;
        opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, the 15-minute ney concert in the&#xD;
        acemasiran tune (instrumental music), which was prepared by the researchers with the service&#xD;
        of the ney artist within the scope of the literature (the scenario determined for the birth&#xD;
        process), was played from the MP3 player via bluetooth headphones. The pregnant woman will be&#xD;
        listened to by the researcher. &quot;VAS&quot; will be applied after each attempt. Data will be&#xD;
        collected by applying &quot;VAS&quot;, &quot;STAI Form TX-1&quot; and &quot;DBSS-2&quot; 1 hour after the birth of the baby&#xD;
        and placenta.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction of labor pain</measure>
      <time_frame>15 minutes</time_frame>
      <description>labor pain assessed by VAS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reduction of Anxiety</measure>
      <time_frame>15 minutes</time_frame>
      <description>anxieties of vaginal birth assessed by STAI Form TX-1</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Labor Pain</condition>
    <arm_group>
      <arm_group_label>guided imagery group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>music group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>guided imagery</intervention_name>
      <description>The guided imagery technique, which is one of these methods, is used in the method of pain by establishing a connection between mind and body. In the technique, a peaceful scene is depicted in which positive energy is reflected in the person to ensure complete relaxation and relaxation.</description>
      <arm_group_label>guided imagery group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>music recital</intervention_name>
      <description>It is stated that the acemasiran tune (instrumental music) has a reducing effect on the duration of labor, as well as having labor pain and muscle relaxant properties.</description>
      <arm_group_label>music group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 18-35,&#xD;
  &#xD;
            -  Primiparous and singleton pregnancy,&#xD;
  &#xD;
            -  No risky pregnancy,&#xD;
  &#xD;
            -  At 38 to 42 weeks of pregnancy,&#xD;
  &#xD;
            -  Being literate and able to speak and understand Turkish,&#xD;
  &#xD;
            -  Pregnant women with a cervical dilation of 4 to 5 cm.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being under the age of 18,&#xD;
  &#xD;
            -  Presence of chronic disease,&#xD;
  &#xD;
            -  Women who became pregnant as a result of the application of assisted reproductive&#xD;
               techniques,&#xD;
  &#xD;
            -  Hearing problem,&#xD;
  &#xD;
            -  Having a known diagnosis of serious psychiatric illness.&#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>Betül Uncu</name>
        <address>
          <city>Istanbul</city>
          <zip>34320</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Biana CB, Cecagno D, Porto AR, Cecagno S, Marques VA, Soares MC. Non-pharmacological therapies applied in pregnancy and labor: an integrative review. Rev Esc Enferm USP. 2021 Apr 16;55:e03681. doi: 10.1590/S1980-220X2019019703681. eCollection 2021. English, Portuguese.</citation>
      <PMID>33886910</PMID>
    </reference>
    <reference>
      <citation>Rantala A, Hakala M, Polkki T. Women's perceptions of the pain assessment and non-pharmacological pain relief methods used during labor: A cross-sectional survey. Eur J Midwifery. 2022 Apr 13;6:21. doi: 10.18332/ejm/146136. eCollection 2022.</citation>
      <PMID>35515089</PMID>
    </reference>
    <reference>
      <citation>Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.</citation>
      <PMID>29589650</PMID>
    </reference>
    <reference>
      <citation>Mirghafourvand M, Mohammad Alizadeh Charandabi S, Ghanbari-Homayi S, Jahangiry L, Nahaee J, Hadian T. Effect of birth plans on childbirth experience: A systematic review. Int J Nurs Pract. 2019 Aug;25(4):e12722. doi: 10.1111/ijn.12722. Epub 2019 Jan 24.</citation>
      <PMID>30675962</PMID>
    </reference>
    <reference>
      <citation>Kacar N, Ozcan Keser N. Comparison of the effect of mechanical massage and warm mechanical massage application on perceived labor pain and childbirth experience: A randomized clinical trial. Eur J Midwifery. 2021 Feb 27;5:5. doi: 10.18332/ejm/132883. eCollection 2021.</citation>
      <PMID>33655203</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Betul Uncu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Birth pain</keyword>
    <keyword>music listening</keyword>
    <keyword>positive birth</keyword>
    <keyword>guided imagery</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>
    <!-- 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/NCT06035172
  org study id: 2022/362
  nct id: NCT06035172
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Purpose: The aim of this project is to examine the effects of guided imagery and music
        performance during labor on labor pain, anxiety and birth experience.
  
        Methods: The research to be carried out within the scope of the project is randomized
        controlled and has an experimental research design. The population of the research consists
        of primiparous pregnant women who applied to the Istanbul Provincial Health Directorate,
        Istanbul Training and Research Hospital, Suleymaniye Obstetrics and Pediatrics Additional
        Service Building, Birth Unit. Eligible participants in the study sample will be randomly
        selected at a 1:1:1 ratio. In the calculation of the sample size, using the G*Power (3.1.9.2)
        program, 5% first type error, 0.30 standardized effect size, distribution ratio to 1 groups,
        90% power considering data loss, and the minimum sample size required for 3 groups was 144
        people in total. calculated as 48 cases for each group. The group of pregnant women who meet
        the inclusion criteria will be determined by using the "Randomizer.org" program. In this
        direction, 48 people (guided imagery) should be included in experiment 1, 48 people in
        experiment 2 (musical concert) and 48 people in control group. "Informed Consent Form" and
        "Voluntary Consent Form" will be presented to the pregnant women included in the study, by
        giving information about the study."Personal Information Form", "Visual Analogue Scale
        (VAS)", "State Trait Anxiety Scale (STAI Form TX-1)" and "Birth Expectations and Experiences
        Scale-Part 1 (DBSS-1)" will be applied to pregnant women assigned to the Guided Imagery
        Group. . In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7
        cm and 8-10 cm, a 15-minute guided imagery concert (of the scenario determined for the birth
        process) prepared by the researchers within the scope of the literature, with the service of
        a ney artist and a psychological counselor, is played by bluetooth from an MP3 player. The
        pregnant woman will be listened to by the researcher through headphones. "VAS" will be
        applied after each attempt. 1 hour after the birth of the baby and placenta, data will be
        collected by applying "VAS", "STAI Form TX-1" and "Birth Expectations and Experiences
        Scale-Part 2 (DBSS-2)".
  
        "Personal Information Form", "VAS", "STAI Form TX-1" and "DBSS-1" will be applied to pregnant
        women assigned to the music concert group. In the active phase of labor, when the cervical
        opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, the 15-minute ney concert in the
        acemasiran tune (instrumental music), which was prepared by the researchers with the service
        of the ney artist within the scope of the literature (the scenario determined for the birth
        process), was played from the MP3 player via bluetooth headphones. The pregnant woman will be
        listened to by the researcher. "VAS" will be applied after each attempt. Data will be
        collected by applying "VAS", "STAI Form TX-1" and "DBSS-2" 1 hour after the birth of the baby
        and placenta.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Reduction of labor pain
  time frame: 15 minutes
  description: labor pain assessed by VAS
  measure: Reduction of Anxiety
  time frame: 15 minutes
  description: anxieties of vaginal birth assessed by STAI Form TX-1
  arm group label: guided imagery group
  arm group type: Experimental
  arm group label: music group
  arm group type: Experimental
  arm group label: Control group
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: guided imagery
  description: The guided imagery technique, which is one of these methods, is used in the method of pain by establishing a connection between mind and body. In the technique, a peaceful scene is depicted in which positive energy is reflected in the person to ensure complete relaxation and relaxation.
  arm group label: guided imagery group
  intervention type: Behavioral
  intervention name: music recital
  description: It is stated that the acemasiran tune (instrumental music) has a reducing effect on the duration of labor, as well as having labor pain and muscle relaxant properties.
  arm group label: music group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  citation: Biana CB, Cecagno D, Porto AR, Cecagno S, Marques VA, Soares MC. Non-pharmacological therapies applied in pregnancy and labor: an integrative review. Rev Esc Enferm USP. 2021 Apr 16;55:e03681. doi: 10.1590/S1980-220X2019019703681. eCollection 2021. English, Portuguese.
  PMID: 33886910
  citation: Rantala A, Hakala M, Polkki T. Women's perceptions of the pain assessment and non-pharmacological pain relief methods used during labor: A cross-sectional survey. Eur J Midwifery. 2022 Apr 13;6:21. doi: 10.18332/ejm/146136. eCollection 2022.
  PMID: 35515089
  citation: Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.
  PMID: 29589650
  citation: Mirghafourvand M, Mohammad Alizadeh Charandabi S, Ghanbari-Homayi S, Jahangiry L, Nahaee J, Hadian T. Effect of birth plans on childbirth experience: A systematic review. Int J Nurs Pract. 2019 Aug;25(4):e12722. doi: 10.1111/ijn.12722. Epub 2019 Jan 24.
  PMID: 30675962
  citation: Kacar N, Ozcan Keser N. Comparison of the effect of mechanical massage and warm mechanical massage application on perceived labor pain and childbirth experience: A randomized clinical trial. Eur J Midwifery. 2021 Feb 27;5:5. doi: 10.18332/ejm/132883. eCollection 2021.
  PMID: 33655203
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Betul Uncu
  investigator title: Principal Investigator
  mesh term: Labor Pain
  sharing ipd: No