The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development
Primary Purpose
Labor Pain, Posttraumatic Growth
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage group
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain
Eligibility Criteria
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
Sites / Locations
- Amasya University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Massage
Music
Control
Arm Description
Massage therapy
Music therapy
Control
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) Score
The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort
Secondary Outcome Measures
Postpartum Comfort Scale
It is possible to score between 34 and 170 on the scale. An increase in the scores obtained from the scale represents a high level of comfort.
Posttraumatic Growth Inventory
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05317052
Brief Title
The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amasya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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 114 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Posttraumatic Growth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage
Arm Type
Experimental
Arm Description
Massage therapy
Arm Title
Music
Arm Type
Experimental
Arm Description
Music therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Massage group
Other Intervention Name(s)
Music group
Intervention Description
Massage and music therapy
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Score
Description
The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort
Time Frame
In the labour (active and transition phase)
Secondary Outcome Measure Information:
Title
Postpartum Comfort Scale
Description
It is possible to score between 34 and 170 on the scale. An increase in the scores obtained from the scale represents a high level of comfort.
Time Frame
At the enf of the delivery (In the 24 th hours)
Title
Posttraumatic Growth Inventory
Description
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.
Time Frame
At the enf of the delivery (In the 24 th hours)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Primiparous pregnant women
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Amasya University
City
Amasya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development
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