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The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development

Sponsor
Amasya University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05317052
Collaborator
(none)
105
Enrollment
1
Location
3
Arms
2.5
Anticipated Duration (Months)
41.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Birth pain is the most severe painful experience faced by primiparous people. Massage and music therapy reduce tension in the muscles and reduce the feeling of pain. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Massage group
 N/A

Detailed Description

Birth pain is one of the most severe and difficult to control pains known. Non-pharmacological methods used to cope with labor pain are cheap and reliable. Massage and music therapy in the first stage of labor are non-pharmacological methods used to reduce labor pain. The purpose of this research; non-pharmacological methods applied to primiparous in labor; The aim of this study is to examine the effects of massage and music therapy on labor pain, postpartum comfort and posttraumatic development. A total of 105 primiparous pregnant women who had a normal delivery expectation and were in the active phase of labor (4-5 cm dilatation) were planned to be included in the study. Massage and music therapy will be applied to pregnant women. No intervention will be made to a group of pregnant women. Numerical Pain Assessment, Post Traumatic Development Scale and Birth Comfort Scale will be used in the research.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
From Non-Pharmacologıcal Methods Applied to Primipars in Travay; The Effect of Massage And Music Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development: A Randomized Controlled Study
Anticipated Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Massage

Massage therapy

Behavioral: Massage group
Massage and music therapy
Other Names:
  • Music group

    		•
    Experimental: Music

    Music therapy

    Behavioral: Massage group
    Massage and music therapy
    Other Names:
  • Music group

    		•
    No Intervention: Control

    Control

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Scale (VAS) Score [In the labour (active and transition phase)]

      The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort

    Secondary Outcome Measures

    1. Postpartum Comfort Scale [At the enf of the delivery (In the 24 th hours)]

      It is possible to score between 9 and 45 on the scale. An increase in the scores obtained from the scale represents a high level of comfort.

    2. Posttraumatic Growth Inventory [At the enf of the delivery (In the 24 th hours)]

      A minimum of 0 and a maximum of 105 points can be obtained from the scale. As the score obtained from the scale increases, it is thought that the level of post-traumatic development is higher.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Expectation of normal vaginal delivery

    • Having a term pregnancy

    • Being primiparous - Being in the active phase of labor (Cervical dilatation 4 cm)

    • Single pregnancy

    • Being in vertex presentation

    • Uncomplicated prenatal process

    • Volunteering to participate in the study

    • Being pregnant without back pain

    Exclusion Criteria:

    • Pregnant women whose birth resulted in cesarean section due to failure of labor to progress during labor

    • Pregnant women who did not undergo induction

    • Pregnant women who underwent pharmacological intervention for labor pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Amasya University Amasya Turkey

    Sponsors and Collaborators

    • Amasya University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emine Akca, Clinical Researcher of the Amasya University Midwifery Department, Amasya University
    ClinicalTrials.gov Identifier:
    NCT05317052
    Other Study ID Numbers:
    • Amasya U
    First Posted:
    Apr 7, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Labor Pain

    Study Results

    No Results Posted as of Apr 7, 2022