Music Therapy for Women, Delivered Via Cesarean Section

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04111575
• Other study ID #: 19.04.2017/No:7-35
• Status: Completed
• Phase: N/A
• Start date: February 5, 2018
• Est. completion date: October 26, 2018

Study information

• Verified date: September 2019
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 26, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Postpartum Period

Intervention

Behavioral:
• Music Therapy
Music Therapy

Locations

Country	Name	City	State
Turkey	Eylem TOKER	Kahramanmaras	Dulkadiroglu

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Inventory	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
Primary	Visual Analog Scale (VAS)	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."

External Links

•   The World Health Statistics 2014. Accessed from: 2018
•   Turkey Demographic and Health Survey 2013. Hacettepe University Institute of Population Studies; 2014; Ankara, Turkey. Accessed from: 2018