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

Sponsor
Cukurova University (Other)
Overall Status
Completed
CT.gov ID
NCT05316415
Collaborator
(none)
80
1
2
26
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Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Other: Acemaşiran Music Group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy
Actual Study Start Date :
Sep 15, 2017
Actual Primary Completion Date :
Sep 15, 2019
Actual Study Completion Date :
Nov 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: Acemaşiran 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

No Intervention: Control Group

Routine clinical care

Outcome Measures

Primary Outcome Measures

  1. 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

  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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cukurova University Balcalı Hospital Adana Saricam Turkey 01330

Sponsors and Collaborators

  • Cukurova University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cemile Onat Koroglu, Lecturer, Cukurova University
ClinicalTrials.gov Identifier:
NCT05316415
Other Study ID Numbers:
  • 2017/65
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cemile Onat Koroglu, Lecturer, Cukurova University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022