Music Therapy for Women, Delivered Via Cesarean Section

September 30, 2019 updated by: Eylem Toker, Kahramanmaras Sutcu Imam University

The Effect of Turkish Classical Music on Postpartum Pain and Anxiety in Women Who Delivered Via Cesarean Section

Musical therapy is a type of therapy which is performed under a regular method by adjusting the physiological and psychological effects of musical tones and melodies in accordance with various situations. Therefore, the study was carried out as a randomized controlled trial in order to evaluate the effect of music therapy on the level of pain and anxiety in the postpartum period in women who delivered via cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: The study was carried out in order to determine the effect of music therapy on the level of postpartum pain and anxiety in women who delivered via cesarean section.

Design, setting and subjects: The randomized controlled trial was conducted on 126 women who delivered via cesarean section in a tertiary hospital. The subjects were allocated to three groups (n=42 each) Interventions: In the experimental group 1 (once a day) and group 2 (twice a day) were made to listen to music for 30 minutes for two consecutive days. The control group routine care of 30 min a day in bed rest. The Personal Information Form, Visual Analog Scale, State-Trait Anxiety Inventory were administered to participants. In the analysis of the data, one-way ANOVA, paired t-test, Kruskal Wallis-H and Wilcoxon tests were used.

Main outcome measures: State anxiety level and pain level.

Study Type

Interventional

Enrollment (Actual)

126

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

  • Turkey
    • Dulkadiroglu
      • Kahramanmaraş, Dulkadiroglu, Turkey, 46100
        • Eylem TOKER

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

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • being at the age of 18 and above,
  • being healthy,
  • having given a live birth,
  • having no hearing impairment,
  • complication not having developed either in the mother or the baby

Exclusion Criteria:

  • being at the age of 17 and below,
  • being unhealthy,
  • having given a stillbirth,
  • having hearing impairment,
  • complication having developed either in the mother or the baby

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: music therapy group 1
The mothers in the experimental group 1 received music therapy for 30 minutes a day.They listened music for two consecutive days, considering the first day after the C-section as the beginning day.
Behavioral: Music Therapy
Music Therapy
Other Names:
  • musicotherapy
Experimental: music therapy group 2
The mothers in the experimental group 1 received music therapy for 30 minutes twice a day. They listened music for two consecutive days, considering the first day after the C-section as the beginning day.
Behavioral: Music Therapy
Music Therapy
Other Names:
  • musicotherapy
No Intervention: control group
the control group were made to rest in bed for 30 minutes a day for two consecutive days, considering the first day after the C-section as the beginning day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State-Trait Anxiety Inventory
Time Frame: On the first and second days after C-section, change from first anxiety level at 30 minutes.The inventory has a Likert type scale of 20 items which aim to measure the state anxiety level.Higher scores indicate greater anxiety
Anxiety level by State-Trait Anxiety Inventory
On the first and second days after C-section, change from first anxiety level at 30 minutes.The inventory has a Likert type scale of 20 items which aim to measure the state anxiety level.Higher scores indicate greater anxiety
Visual Analog Scale (VAS)
Time Frame: On the first and second days after C-section, change from first pain level at 30 minute.The patient marks the pain he/she feels on a scale of 10 cm (100 mm), pain point 1 means "no pain", pain point 10 means "worst pain possible."
Pain Level by Visual Analog Scale
On the first and second days after C-section, change from first pain level at 30 minute.The patient marks the pain he/she feels on a scale of 10 cm (100 mm), pain point 1 means "no pain", pain point 10 means "worst pain possible."

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

February 5, 2018

Primary Completion (Actual)

July 2, 2018

Study Completion (Actual)

October 26, 2018

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19.04.2017/No:7-35

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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