Music Therapy for Women, Delivered Via Cesarean Section

NCT ID: NCT04111575

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2018-10-26

Brief Summary

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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

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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.

Conditions

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Cesarean Section Postpartum Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type BEHAVIORAL

Music Therapy

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.

Group Type EXPERIMENTAL

Music Therapy

Intervention Type BEHAVIORAL

Music Therapy

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Therapy

Music Therapy

Intervention Type BEHAVIORAL

Other Intervention Names

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musicotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Eylem Toker

Assistant Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eylem TOKER

Kahramanmaraş, Dulkadiroglu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Related Links

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http://apps.who.int/iris/bitstream/10665/112738/1/9789240692671_eng.pdf?ua=1.

The World Health Statistics 2014. Accessed from: 2018

Other Identifiers

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19.04.2017/No:7-35

Identifier Type: -

Identifier Source: org_study_id

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