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

Primary Purpose

Pregnancy, High Risk, Anxiety State, Sleep Quality

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acemaşiran Music Group
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy, High Risk focused on measuring Anxiety, bed rest, high-risk pregnancy, music, sleep quality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cukurova University Balcalı Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acemaşiran Music Group

Control Group

Arm Description

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

Routine clinical care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2022
Last Updated
March 30, 2022
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05316415
Brief Title
The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy
Official Title
The Effects of Music on the Anxiety and Sleep Quality of Pregnant Women on Bed Rest for a High-risk Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
September 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, High Risk, Anxiety State, Sleep Quality
Keywords
Anxiety, bed rest, high-risk pregnancy, music, sleep quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acemaşiran Music Group
Arm Type
Experimental
Arm Description
Listening to Acemaşiran music for 40 minutes in successive three days and two times a day (noon and evening) Routine clinical care
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine clinical care
Intervention Type
Other
Intervention Name(s)
Acemaşiran Music Group
Intervention Description
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
Primary Outcome Measure Information:
Title
State-trait Anxiety Inventory
Description
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
Time Frame
Two hours after the last listening session, the participants were administered the State-trait anxiety inventory to measure
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
. Two hours after the last listening session, the participants were administered the Pittsburg Sleep Quality Index to measure their sleep quality.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cukurova University Balcalı Hospital
City
Adana
State/Province
Saricam
ZIP/Postal Code
01330
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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