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CompletedNCT05602883Updated Sep 4, 2026

Music Therapy in the Threat of Premature Birth

An interventional study of music therapy in Sleep Quality, Premature Labor and Risk-Taking, sponsored by Sakarya University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

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

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The scope of the study covers the effects of music therapy on risk perception levels and sleep quality in pregnant women hospitalized due to the diagnosis of premature birth threat.

Read the detailed description

Premature labor is an action accompanied by cervical effacement and dilatation with contractions that occur between the 20th and 37th weeks of pregnancy, occur 2 times in 10 minutes or 3-4 times in 30 minutes, and last at least 30 seconds. The threat of premature birth is 20-37. It is a condition in which uterine contractions are not accompanied by cervical effacement and dilatation between weeks of pregnancy. Premature birth is one of the main causes of perinatal mortality and morbidity.

Although the prevalence of threat of premature birth differs from society to society, it was determined as 17.3% in our country. There is no definitive cure for threat of premature birth. Measures and treatments are applied to reduce the risk of preterm birth. These are classified as bed rest, sedation, hydration and tocolytic agents. In addition, pregnant women should be kept under surveillance and followed in the hospital for the correct diagnosis and management of treatment. Being sick and being hospitalized affect the pregnant woman's life in various ways; It increases anxiety and can disrupt life balance. In high-risk pregnancies, the stress experienced due to maternal or fetal problems is higher than in normal pregnancies. Experiencing intense stress during pregnancy causes suppression of the immune system, decreased fetal birth weight and increased risk of preterm birth. Being aware of the stressors and using appropriate stress coping methods in high-risk pregnancy may provide better health outcomes for the mother and baby.

Relaxation exercises, breathing exercises, physical exercise, dreaming (catathymia), yoga, massage therapy, acupuncture, biological feedback, providing social support, music therapy, strengthening spirituality are effective coping methods in coping with the stress that occurs in high-risk pregnancy. Music, which is one of these methods, is frequently used by health professionals. Music therapy causes the release of endorphins and provides relaxation in the muscles, lowers blood pressure, decreases heart rate and respiratory rate, and positively affects the emotional state, improves maternal condition and creates a comfortable environment for the fetus. There are studies showing that music reduces anxiety, stress and pain during preterm labor, delivery and cesarean section. It is also an inexpensive, safe, and easy-to-learn method by health care professionals. In a study by Yang et al. (2009), the effect of music therapy in reducing anxiety for women on antepartum bed rest was investigated. It was determined that anxiety levels and physiological responses during bed rest in the intervention group were significantly reduced by music therapy. It was concluded that music can be a cheap and effective method to reduce anxiety in high-risk pregnancies. In the study of Liu et al. (2010) on music, it was determined that music can be used as a non-medical coping method in reducing labor pain and anxiety. Health professionals should encourage pregnant women to listen to relaxing music, determine the appropriate time for listening to music (while doing daily chores, listening to a relaxing and pleasant music while taking a warm shower, etc.), providing comfort and giving attention to music. One of the important factors in ensuring the comfort of pregnant women in the hospital is sleep. Sleep quality has been strongly associated with a person's quality of life. Sleep disturbance in pregnant women has also been associated with an increase in inflammatory and oxidative stress markers that indicate endothelial damage and metabolic status.

Changes in sleep quality are closely related to stress and anxiety. However, music therapy, which is one of the inexpensive, easily applicable and accessible, non-pharmacological coping methods, has not been studied in pregnant women diagnosed with premature birth threat. Therefore, the aim of this study is to determine the effect of music therapy on risk perception and sleep quality in pregnant women diagnosed with preterm birth threat.

02

Conditions studied

  • Sleep Quality
  • Premature Labor
  • Risk-Taking

Keywords

  • premature birth threat
  • sleep quality
  • risk perception
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's enrollment of 80 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being hospitalized with a diagnosis of premature birth threat,
  • be able to speak Turkish,
  • be able to communicate verbally and in writing,
  • volunteering to participate in research
  • single pregnancy,
  • be between 18-45 years old

Exclusion criteria

Exclusion Criteria:

  • be deaf,
  • using sleep-related medication
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Experimental group

    Experimental: Experimental group Pregnant women in this group will listen to a music of their choice for 20 minutes before going to bed at night.

    Behavioral: music therapy

  • No intervention
    Control group

    Women in the control group will not be interfered with and will be followed in line with the routine follow-up protocol of the clinic.

Interventions

  • Behavioralmusic therapy

    Music is played for 20 minutes to the pregnant woman who is hospitalized due to the threat of premature birth.

06

What researchers measure

Primary outcomes

  1. Richard Campbell Sleep Quality Scale

    The Richard Campbell Sleep Quality Scale is a 6-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart between 0 and 100 using the visual analog scale technique. A score of "0-25" from the scale indicates very bad sleep, and a score of "76-100" indicates very good sleep. The total score of the scale is evaluated over 5 items, and the 6th item, which evaluates the noise level in the environment, is excluded from the total score evaluation. As the score of the scale increases, the sleep quality of the patients also increases.

    Time frame: 4 days

  2. Risk Perception Scale in Pregnancy

    The scale is a visual analog measuring tool. Just below each item on the scale is a 0-100 mm linear line with the words "no risk" and "extremely high risk". The total score of the scale; It is calculated by adding the scores for each of the nine items and dividing the obtained score by 9. The scale has no breakpoints. An increase in the score obtained from the scale is interpreted as an increase in the risk perception of the pregnant woman and her baby.

    Time frame: 4 days

07

Study locations

1 site
  • Zeynep Kamil Gynecology and Pediatrics Hospital
    Istanbul, Istanbul 34200, Turkey (Türkiye)
08

References and documents

Publications

  • Liu YH, Lee CS, Yu CH, Chen CH. Effects of music listening on stress, anxiety, and sleep quality for sleep-disturbed pregnant women. Women Health. 2016;56(3):296-311. doi: 10.1080/03630242.2015.1088116. Epub 2015 Sep 11. PubMed 26361642 ↗
  • Heaman MI, Gupton AL. Psychometric testing of the Perception of Pregnancy Risk Questionnaire. Res Nurs Health. 2009 Oct;32(5):493-503. doi: 10.1002/nur.20342. PubMed 19606451 ↗
  • Hansen IP, Langhorn L, Dreyer P. Effects of music during daytime rest in the intensive care unit. Nurs Crit Care. 2018 Jul;23(4):207-213. doi: 10.1111/nicc.12324. Epub 2017 Nov 20. PubMed 29159864 ↗
  • Nour NM. Premature delivery and the millennium development goal. Rev Obstet Gynecol. 2012;5(2):100-5. PubMed 22866189 ↗
  • Shin HS, Kim JH. Music Therapy on Anxiety, Stress and Maternal-fetal Attachment in Pregnant Women During Transvaginal Ultrasound. Asian Nurs Res (Korean Soc Nurs Sci). 2011 Mar;5(1):19-27. doi: 10.1016/S1976-1317(11)60010-8. Epub 2011 Apr 5. PubMed 25029946 ↗
  • Yang M, Li L, Zhu H, Alexander IM, Liu S, Zhou W, Ren X. Music therapy to relieve anxiety in pregnant women on bedrest: a randomized, controlled trial. MCN Am J Matern Child Nurs. 2009 Sep-Oct;34(5):316-23. doi: 10.1097/01.NMC.0000360425.52228.95. PubMed 19713801 ↗
  • Liu YH, Chang MY, Chen CH. Effects of music therapy on labour pain and anxiety in Taiwanese first-time mothers. J Clin Nurs. 2010 Apr;19(7-8):1065-72. doi: 10.1111/j.1365-2702.2009.03028.x. PubMed 20492051 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2022 to primary completion in Nov 2023, 12 months.

Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 12 months is below that.

Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2022
First posted
Nov 2, 2022
StartActual
Nov 1, 2022
Primary completionActual
Nov 30, 2023
CompletionActual
May 15, 2024
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05602883
Lead sponsor
Sakarya University
Responsible party
yasemin hamlacı başkaya (Head of Midwifery Depatment, Sakarya University) — Principal investigator
First posted
Nov 2, 2022
Start date
Nov 1, 2022
Primary completion
Nov 30, 2023
Completion
May 15, 2024
Last update
Sep 4, 2026

Study contacts

Yasemin Hamlacı Baskaya
study director · Sakarya University

Oversight

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

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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