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CompletedNCT05316415Updated Apr 7, 2022

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

An interventional study of Acemaşiran Music Group in Pregnancy, High Risk, Anxiety State and Sleep Quality, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.

Sponsored by Cukurova University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled Sep 2017, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
Female
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Study 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 .

Read the 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.

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Conditions studied

  • Pregnancy, High Risk
  • Anxiety State
  • Sleep Quality

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Keywords

  • Anxiety
  • bed rest
  • high-risk pregnancy
  • music
  • sleep quality
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In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 80 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

  • Fetal congenital anomalies
  • Having a hearing impairment
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • 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

  • No intervention
    Control Group

    Routine clinical care

Interventions

  • OtherAcemaşiran 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

06

What researchers measure

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

    Time frame: 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

    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.

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Study locations

1 site
  • Cukurova University Balcalı Hospital
    Adana, Saricam 01330, Turkey
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05316415
Lead sponsor
Cukurova University
Responsible party
Cemile Onat Koroglu (Lecturer, Cukurova University) — Principal investigator
First posted
Apr 7, 2022
Start date
Sep 15, 2017
Primary completion
Sep 15, 2019
Completion
Nov 15, 2019
Last update
Apr 7, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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