The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy

Not Applicable

Completed

• Conditions: Sleep Quality; Pregnancy, High Risk; Anxiety State
• Interventions: Other: Acemaşiran Music Group

• Registration Number: NCT05316415
• Lead Sponsor: Cukurova University

Brief Summary

The purpose of this study is to identify the effects of music on the anxiety and sleep quality of women with high-risk pregnancy having bed rest in the hospital in Turkey.

This randomized-controlled study involved 80 control and 80 experimental group with a high-risk pregnant woman .

Detailed Description

The literature review indicates a limited number of studies on the effects of music in eliminating the anxiety and sleep problems in women with a high-risk pregnancy having bed rest in the hospital; the existing studies were found to be mainly about anxiety. The purpose of this study is to identify the effects of music on the anxiety and sleep quality of women with a high-risk pregnancy having bed rest in the hospital.

This study adopted a pretest-posttest randomized controlled study involved 80 control and 80 experimental group with a high-risk pregnant woman . The women in the experimental group listened to Acemaşiran music for 40 minutes in successive three days and two times a day.

Study Timeline

• Study Start: 2017-09-15
• Primary Completion: 2019-09-15
• Study Completion: 2019-11-15
• Study First Submitted: 2022-02-14
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Agreeing to participate in the study
• Knowing Turkish and being literate
• Having been hospitalized for bed rest for at least 5 days.
• Having a gestational age of 28 to 36 weeks
• Being hospitalized due to at least one of the diagnoses including hypertensive diseases, diabetes mellitus, preterm labor, placenta previa, cervical insufficiency, or premature rupture of the membrane

Exclusion Criteria

• Fetal congenital anomalies
• Having a hearing impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acemaşiran Music Group	Acemaşiran Music Group	Listening to Acemaşiran music for 40 minutes in successive three days and two times a day (noon and evening) Routine clinical care

Primary Outcome Measures

Name	Time	Method
State-trait Anxiety Inventory	Two hours after the last listening session, the participants were administered the State-trait anxiety inventory to measure	The inventory developed by Spielberger et al. in 1970 consists of two parts that measure two different aspects of anxiety, which are state and trait anxiety. Two inventories are printed on separate pages, and each inventory has 20 questions

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index	. Two hours after the last listening session, the participants were administered the Pittsburg Sleep Quality Index to measure their sleep quality.	The PSQI consists of 19 self-rated questions, and 5 questions rated by the bedpartner or roommate. The 19 self-rated questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep-related problems. Each subscale is scored between 0 and 3, and the total score to be obtained from the scale ranges between 0 and 21.

Trial Locations

Locations (1)

Cukurova University Balcalı Hospital; 🇹🇷 Adana, Saricam, Turkey