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

NCT05316415 | Completed

• 1 other identifier: 2017/65
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 .

Conditions

Pregnancy, High Risk; Anxiety State; Sleep Quality

Keywords

Anxiety; bed rest; high-risk pregnancy; music; sleep quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Acemaşiran Music Group

EXPERIMENTAL

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

Other: Acemaşiran Music Group

Control Group

NO INTERVENTION

Routine clinical care

Interventions

Acemaşiran Music Group OTHER

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

Acemaşiran Music Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Fetal congenital anomalies
• Having a hearing impairment

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Balcalı Hospital

Adana, Saricam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: April 7, 2022
• Study Start: September 15, 2017
• Primary Completion: September 15, 2019
• Study Completion: November 15, 2019
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)