Music Therapy in the Threat of Premature Birth

NCT05602883 | Completed

• 1 other identifier: 29092022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Quality; Premature Labor; Risk-Taking

Keywords

premature birth threat; sleep quality; risk perception

Outcome Measures

Primary Outcomes (2)

• 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.

  4 days

• 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.

  4 days

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental: Experimental group Pregnant women in this group will listen to a music of their choice for 30 minutes before going to bed at night.

Behavioral: music therapy

Control group

NO INTERVENTION

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

music therapy BEHAVIORAL

Music is played for 30 minutes to the pregnant woman who is hospitalized due to the threat of premature birth.

Experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• be deaf,
• using sleep-related medication

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Zeynep Kamil Gynecology and Pediatrics Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 26361642 RESULT

• 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.

  PMID: 19606451 RESULT

• 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.

  PMID: 29159864 RESULT

• Nour NM. Premature delivery and the millennium development goal. Rev Obstet Gynecol. 2012;5(2):100-5.

  PMID: 22866189 RESULT

• 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.

  PMID: 25029946 RESULT

• 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.

  PMID: 19713801 RESULT

• 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.

  PMID: 20492051 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Obstetric Labor, Premature; Risk-Taking

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yasemin Hamlacı Baskaya

  Sakarya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since there is no placebo group, masking will not be done.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Midwifery Depatment

Model Details: While the experimental group will listen to music at night, Routine midwifery care will be applied to the control group.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: November 2, 2022
• Study Start: November 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: May 15, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)