Classical Turkish Music for Pregnant Women With Preeclampsia

NCT06315985 | Not Yet Recruiting

• 1 other identifier: GAksoy
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Stress and Sleep of Classical Turkish Music in Pregnant Women Diagnosed with Preeclampsia in Clinics The study to be carried out to determine the effect on quality is a randomized controlled experimental research. All patients who comply with the limitations of the study and volunteer will be included in the study. When the studies in the literature are examined, there are a limited number of studies on the effects of music on pregnant women diagnosed with preeclampsia, and no studies have been found on the effects of music on stress and sleep quality in pregnant women with preeclampsia. This research aimed to determine the effect of Classical Turkish Music on stress and sleep quality in pregnant women diagnosed with Preeclampsia in clinics.

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia; Classical Turkish Music; Sleep Quality; Stress

Outcome Measures

Primary Outcomes (1)

• Perceived Stress

  It was developed by Cohen et al. in 1983, and Turkish validity and reliability studies were conducted by Erci in 2006. Perceived Stress Scale: 7 items containing positive statements (items 4-5-6-7-9-10 and 13) are scored in reverse and consists of 14 items in total. These items are scored by the individual on a 5-point Likert type scale (1=Never, 2=Almost never, 3=Sometimes, 4=Often, 5=Very often). The analysis of the scale is carried out on the total score. A high total score means a high Perceived Stress Level Scale. It can be said that participants whose score range is between 0-35 are at a positive stress level, can cope with stress effectively, and the coping mechanisms they use are functional. It can be said that the methods used by the participants with a score range between 36-56 are not functional and therefore they cannot cope with stress effectively.

  15-30 minutes

Secondary Outcomes (1)

• Sleep Quality

  15-30 minutes

Study Arms (2)

Experimental Group

EXPERIMENTAL

This was a parallel group, randomized controlled trial. Experimental Group will listen to the music for three days.

Other: Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia

Control Group

NO INTERVENTION

Control Group will take routine care

Interventions

Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia OTHER

The music to be used in the research will be applied together with midwifery practices and is not a treatment option, tool or treatment option for any disease. Although listening to Classical Turkish music has no effect on treatment and care, it does not have a harmful effect on pregnant women. The participant can withdraw from the study at any time without giving any reason. The Personal Information Form, Perceived Stress Scale, and Pittsburgh Sleep Quality Index (PSQI) will be administered to the pregnant women in both groups participating in the study by face-to-face interviews with the individuals on the first day of their admission to the clinic. At the end of the third day, the Perceived Stress Scale and Pittsburgh Sleep Quality Index (PSQI) scales will be re-administered to both groups.

Also known as: Experimental group:

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Pregnant women are hospitalized for three to five days with the diagnosis of Preeclampsia,
• No hearing problems (as music will be played),
• Having the appropriate level of consciousness,
• Must be at least literate (in order to obtain consent),
• Being over 18 years old (in order to obtain consent),
• No communication problems,
• Having a live fetus.
• Pregnant women who agree to participate in the research verbally and in writing will be included in the research.

You may not qualify if:

• Not agreeing to participate in the research verbally or in writing,
• Illiteracy,
• Not being under 18 years of age,
• Having a communication problem,
• Having a hearing problem,
• Being hospitalized for less than three days with a diagnosis of preeclampsia,
• Taking MgSO4
• Having previously been diagnosed with a sleep disorder
• Having a diagnosis of DM other than preeclampsia
• Being hospitalized for less than three days with a diagnosis of preeclampsia,
• The newborn is not healthy.

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Gülay Aksoy

Mersin, 33080, Turkey (Türkiye)

Location

Related Publications (11)

• Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.

  PMID: 32443079 BACKGROUND

• Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

  PMID: 24150027 BACKGROUND

• Chang SC, Chen CH. Effects of music therapy on women's physiologic measures, anxiety, and satisfaction during cesarean delivery. Res Nurs Health. 2005 Dec;28(6):453-61. doi: 10.1002/nur.20102.

  PMID: 16287051 BACKGROUND

• Dag ZO, Isik Y, Turkel Y, Alpua M, Simsek Y. Atypical eclampsia and postpartum status epilepticus. Pan Afr Med J. 2015 Jan 7;20:17. doi: 10.11604/pamj.2015.20.17.5831. eCollection 2015.

  PMID: 25995814 BACKGROUND

• Hansson SR, Naav A, Erlandsson L. Oxidative stress in preeclampsia and the role of free fetal hemoglobin. Front Physiol. 2015 Jan 13;5:516. doi: 10.3389/fphys.2014.00516. eCollection 2014.

  PMID: 25628568 BACKGROUND

• Jung E, Romero R, Yeo L, Gomez-Lopez N, Chaemsaithong P, Jaovisidha A, Gotsch F, Erez O. The etiology of preeclampsia. Am J Obstet Gynecol. 2022 Feb;226(2S):S844-S866. doi: 10.1016/j.ajog.2021.11.1356.

  PMID: 35177222 BACKGROUND

• Reutrakul S, Van Cauter E. Sleep influences on obesity, insulin resistance, and risk of type 2 diabetes. Metabolism. 2018 Jul;84:56-66. doi: 10.1016/j.metabol.2018.02.010. Epub 2018 Mar 3.

  PMID: 29510179 BACKGROUND

• Spehar SM, Mission JF, Amanda Shupe, Facco FL. Prolonged antepartum hospitalization: no time for rest. J Perinatol. 2018 Sep;38(9):1151-1156. doi: 10.1038/s41372-018-0155-2. Epub 2018 Jul 9.

  PMID: 29983417 BACKGROUND

• Thilaganathan B, Kalafat E. Cardiovascular System in Preeclampsia and Beyond. Hypertension. 2019 Mar;73(3):522-531. doi: 10.1161/HYPERTENSIONAHA.118.11191.

  PMID: 30712425 BACKGROUND

• 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 BACKGROUND

• Akolekar R, Syngelaki A, Poon L, Wright D, Nicolaides KH. Competing risks model in early screening for preeclampsia by biophysical and biochemical markers. Fetal Diagn Ther. 2013;33(1):8-15. doi: 10.1159/000341264. Epub 2012 Aug 16.

  PMID: 22906914 BACKGROUND

Related Links

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• WHO, 2020
• World Health Organization, 2023, Trends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population Division
• World Health Organization, UNICEF, United Nations Population Fund and The World Bank, Trends in Maternal Mortality: 2000 to 2020 WHO, Geneva, 2023.
• Yüksekol, Ö. D., \& Başer, M. (2020). Preeklampsili Gebelerde Tamamlayıcı Ve Bütünleşik Terapilerin Kullanımı. Turkish Journal of Science and Health, 1(2), 79-83
• Yousefzadeh, 2022; Covıd-19 Pandemisinin Gebelikte Stres Ve Yaşam Kalitesi Üzerine Etkisi, Yükseklisans Tezi
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MeSH Terms

Conditions

Pre-Eclampsia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Gülay Aksoy

CONTACT

+905518627438; 220931003@tarsus.edu.tr

Eylem Toker

CONTACT

eylemtoker@tarsus.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife, Student on master degree program at Tarsus University Midwifery Department

Model Details: This was a parallel group, randomized controlled trial conducted in a tertiary hospital in Mersin city center, Turkey. In parallel with the purpose of the study, participants were selected from the pregnant women diagnosed with preeclampsia who were hospitalized at Mersin City Training and Research Hospital.The population of the research is the G\* Power 3.1.9.4 was determined by analysis using. In the analysis, the sample size was taken as a sample size of at least 80%, a medium effect size (0.5) and a two-way type 1 error value of 0.05, since no study similar to the study could be found, and a total of 128 pregnant women were included in the two groups (in each group) to determine the difference between the averages of two independent groups. It was calculated as 64 pregnant women). Considering the drop out rate of 10% during the research, the total number of samples was found to be 142 (experimental group: n=71, control group: n=71) pregnant women.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: March 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: March 20, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)