Classical Turkish Music for Pregnant Women With Preeclampsia

Pre-Eclampsia Clinical Trial

Official title:

The Effect of Classical Turkish Music on Stress and Sleep Quality in Pregnant Women Diagnosed With Preeclampsia in the Clinic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315985
• Other study ID #: GAksoy
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2024
• Source: Tarsus University
• Contact: Gülay Aksoy
• Phone: +905518627438
• Email: 220931003[@]tarsus.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pregnancy is a natural process that has physiological, psychological and sociological effects on women's lives and is special and important for every woman, affecting both the person and her family (Koyucu et al., 2020; Toker, 2018; Coşkun, 2016). Maternal age, number of pregnancies and births, adverse environmental conditions such as alcohol and cigarette use, radiation, malnutrition, diseases the woman has during the pre-pregnancy period or diseases that occur during pregnancy all negatively affect the health of the mother and the fetus, leading to a risky pregnancy. (Taşkın, 2016; Toker, 2018). According to Turkey Demographic and Health Survey 2018 (TNSA, 2018) data, when births occurring in Turkey are examined, it is seen that 65.7% are in any high risk category and 35% are in at least one inevitable high risk category (TNSA , 2018). According to the report titled "Trends in Maternal Mortality" prepared by the World Health Organization (WHO), UNICEF, UNFPA, World Bank Group and UNDESA/Population Division; In 2020, an estimated 287,000 women per year worldwide died from preventable causes related to pregnancy and childbirth, approximately 800 every day; This means that one woman dies every two minutes (UNFPA, 2023; WHO, 2023; UNICEF, 2023; WHO, 2023). According to the 2020 data of the Ministry of Health, maternal mortality rates in our country decreased to 13.1 per hundred thousand as of 2019 (Ministry of Health, 2020). 10-15% of direct maternal deaths worldwide are related to preeclampsia and eclampsia, ranking 3rd among major complications (Akolekar et al., 2013; Demirci, 2022; WHO, 2020). According to 2019 data in our country, the first four most common causes of maternal deaths are; cardiovascular diseases (29%), embolism (16.1%), hypertension (14.2%) and bleeding (10.3%) (Maternal deaths study report, 2021; Republic of Turkey Ministry of Health Health Statistics Yearbook, 2021) . According to 2022 data of the Turkish Gynecology and Obstetrics Association, it is estimated that at least 42,000 maternal deaths annually are caused by preeclampsia (Turkish Gynecology and Obstetrics Association, 2022). Preeclampsia; It is a pregnancy-specific disease and is a symptom characterized by hypertension (systolic blood pressure 140 mmHg and above and/or diastolic blood pressure 90 mmHg and above) and end organ dysfunction with or without proteinuria after the 20th week of pregnancy (Jung and al., 2022). Preeclampsia is a disease whose physiopathology is still not fully known. The decline in prognosis with the disappearance of the placenta after birth indicates that preeclampsia may be of placental origin (Thilaganathan & Kalafat., 2019). Preeclampsia causes dysfunction in the liver, kidney, uterus, respiratory, cerebrovascular and cardiovascular systems. If it is not diagnosed at an early stage and appropriate treatment is not provided, it may become severe in a short time and turn into eclampsia. Eclampsia is a condition that occurs with the addition of convulsions in a pregnant woman with preeclampsia symptoms, without any neurological or metabolic disease (Hansson et al., 2015; Dag et al., 2015; Günkur, 2019; Akalın & Şahin, 2018). Since preeclampsia is in the risk category during pregnancy, it may cause increased anxiety in pregnant women regarding birth and motherhood, as well as conditions such as stress and sleep disorders. In this context, the physiological health of the pregnant woman also negatively affects her psychosocial state. Hospitalization experience and bed rest in pregnant women with a risky pregnancy diagnosis such as preeclampsia; Reasons such as being away from family and home, activity limitation, uncertainty, being in an unknown environment, not being able to fulfill their roles, anxiety about the fetus and their own health, repeated laboratory and screening tests can cause stressful results (Gourounti et al., 2015; Özçetin & Erkan). , 2019). In the studies carried out; It has been determined that the risk of IUGR increases in women with high stress levels during pregnancy, there is an increase in cortisol and adrenaline levels, there is a decrease in dopamine and serotonin levels, the fetus is more active, and mood and irregular sleep changes are experienced more frequently in the pregnant woman (Yousefzadeh, 2022; Spehar et al. ., 2018; Şen, 2020; Karadeniz et al., 2023). Again in the literature; It has been stated that in pregnant women hospitalized in clinics, insomnia complaints are common during hospitalization due to the treatment regimen and hospital conditions, and there is dissatisfaction with sleep quality (Spehar et al., 2018; Şen, 2020; Karadeniz et al., 2023). However, approximately 1/3 of human life is spent sleeping. Restricting sleep or reducing its quality are factors that can cause detrimental effects on life expectancy and quality (Ulusoy, 2020; Reutrakul & Van, 2018). With sleep problems during pregnancy; adverse perinatal outcomes such as increases in blood pressure, Type of Research: It was planned as a randomized controlled experimental study to determine the effect of Classical Turkish Music on Stress and Sleep Quality in Pregnant Women Diagnosed with Preeclampsia. All patients who comply with the limitations of the study and volunteer will be included in the study. The research is a cross-sectional study, and quantitative data will be collected using the online survey technique, one of the data collection methods.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 142
• Est. completion date: March 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
Turkey	Gülay Aksoy	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. Erratum In: Fetal Diagn Ther. 2013;34(1):43. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sleep Quality	It was developed by Buyssee et al. in 1989 to evaluate sleep quality in clinical research and psychiatric practices, and its Turkish validity and reliability was confirmed by Agargün et al. in 1996. PSQI is a 24-question index consisting of 20 questions valued from 0 to 3 and 4 open-ended questions. The patient answers 19 questions himself, while the patient's roommate or bedmate answers 5 questions. The 19 questions answered by the patient are evaluated in 7 categories and combined to obtain the PSQI global score, which ranges between 0 and 21. A total score from the scale greater than 5 is evidence of poor sleep quality.	15-30 minutes

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