- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317052
The Effect of Massage and Musıc Therapy on Birth Pain, Posttravmatic Comfort and Posttraumatic Development
February 23, 2023 updated by: Emine Akca, Amasya University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amasya, Turkey
- Amasya University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Massage
Massage therapy
|
Massage and music therapy
Other Names:
|
Experimental: Music
Music therapy
|
Massage and music therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) Score
Time Frame: In the labour (active and transition phase)
|
The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort
|
In the labour (active and transition phase)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posttraumatic Growth Inventory
Time Frame: 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.
|
At the enf of the delivery (In the 24 th hours)
|
Postpartum Comfort Scale
Time Frame: At the enf of the delivery (In the 24 th hours)
|
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.
|
At the enf of the delivery (In the 24 th hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
March 30, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
April 7, 2022
Study Record Updates
Last Update Posted (Actual)
February 24, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Amasya U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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