Music Therapy for Women, Delivered Via Cesarean Section

Not Applicable

Completed

• Conditions: Postpartum Period; Cesarean Section
• Interventions: Behavioral: Music Therapy

• Registration Number: NCT04111575
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief Summary

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.

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 Timeline

• Study Start: 2018-02-05
• Primary Completion: 2018-07-02
• Study Completion: 2018-10-26
• Status Verified: 2019-09
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-30
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
music therapy group 1	Music Therapy	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.
music therapy group 2	Music Therapy	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.

Primary Outcome Measures

Name	Time	Method
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	Anxiety level by State-Trait Anxiety Inventory
Visual Analog Scale (VAS)	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

Trial Locations

Locations (1)

Eylem TOKER; 🇹🇷 Kahramanmaraş, Dulkadiroglu, Turkey