Clinical trial NCT05602883: Music Therapy in the Threat of Premature Birth
Official title: The Effect of Music Therapy on Risk Perception and Sleep Quality in Preterm Birth Threat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Premature Labor
Risk-Taking
Keywords: premature birth threat
sleep quality
risk perception
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: While the experimental group will listen to music at night, Routine midwifery care will be applied to the control group.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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:

* be deaf,
* using sleep-related medication

Primary outcomes:
measure: Richard Campbell Sleep Quality Scale
timeFrame: 4 days
measure: Risk Perception Scale in Pregnancy
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Gynecology and Pediatrics Hospital
Study officials:
affiliation: Sakarya University
name: Yasemin Hamlacı Baskaya
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Nour NM. Premature delivery and the millennium development goal. Rev Obstet Gynecol. 2012;5(2):100-5.
citation: 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.
citation: 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.
citation: 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.