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Completed

NCT Number: NCT05316415

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

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 .

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University Balcalı Hospital

Adana, Saricam, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. State-trait Anxiety Inventory

    Time frame: 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 outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: . 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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