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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05317052
Other study ID # Amasya U
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2022
Est. completion date July 1, 2022

Study information

Verified date February 2023
Source Amasya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date July 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Massage group
Massage and music therapy

Locations

Country Name City State
Turkey Amasya University Amasya

Sponsors (1)

Lead Sponsor Collaborator
Amasya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) Score The score ranges from 1 to 10 peints, with increasing score reflecting more discomfort In the labour (active and transition phase)
Secondary 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. At the enf of the delivery (In the 24 th hours)
Secondary 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. At the enf of the delivery (In the 24 th hours)
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