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

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316415
• Other study ID #: 2017/65
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: November 15, 2019

Study information

• Verified date: March 2022
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Pregnancy, High Risk
• Sleep Quality

Intervention

Other:
• Acemasiran Music Group
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

Locations

Country	Name	City	State
Turkey	Cukurova University Balcali Hospital	Adana	Saricam

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-trait Anxiety Inventory	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	Two hours after the last listening session, the participants were administered the State-trait anxiety inventory to measure
Secondary	Pittsburgh Sleep Quality Index	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.	. Two hours after the last listening session, the participants were administered the Pittsburg Sleep Quality Index to measure their sleep quality.