Clinical trial NCT04111575: Music Therapy for Women, Delivered Via Cesarean Section
Official title: The Effect of Turkish Classical Music on Postpartum Pain and Anxiety in Women Who Delivered Via Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Postpartum Period
Keywords: cesarean section
Music therapy
Anxiety
Pain
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: 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
measure: Visual Analog Scale (VAS)
timeFrame: 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."
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Eylem TOKER
state: Dulkadiroglu
Study officials:
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