Pre-EclampsiaNCT06315985
Classical Turkish Music for Pregnant Women With Preeclampsia
A study testing Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia in people with Pre-Eclampsia, run by Tarsus University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Eylem Toker contact
Turkey (Türkiye)1 site
Gülay Aksoy
Mersin, 33080
Gülay Aksoy, +905518627438, 220931003@tarsus.edu.tr
Eylem Toker, eylemtoker@tarsus.edu.tr
About this study
Official title: The Effect of Classical Turkish Music on Stress and Sleep Quality in Pregnant Women Diagnosed With Preeclampsia in the Clinic
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.
Read the detailed 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.
- Conditions
- Pre-Eclampsia
- Being tested
- Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia
- Keywords
- Pre-Eclampsia, Classical Turkish Music, Sleep Quality, Stress
- Medical subject headings
- Pre-Eclampsia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsiaOther
Also called Experimental group:
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This was a parallel group, randomized controlled trial. Experimental Group will listen to the music for three days. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15-30 minutes
Secondary outcomes (1)
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 Ağargün 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.
Measured: 15-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start20 Mar 2024 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay Aksoy, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315985
- Sponsor's protocol ID
- GAksoy
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
PubMed 32443079Hypertension 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.
PubMed 24150027Chang 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.
PubMed 16287051Dag 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.
PubMed 25995814Hansson 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.
PubMed 25628568Jung 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.
PubMed 35177222Reutrakul 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.
PubMed 29510179Spehar 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.
PubMed 29983417Thilaganathan B, Kalafat E. Cardiovascular System in Preeclampsia and Beyond. Hypertension. 2019 Mar;73(3):522-531. doi: 10.1161/HYPERTENSIONAHA.118.11191.
PubMed 30712425Yang 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 19713801Akolekar 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.
PubMed 22906914
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Classical Turkish Music on Stress and Sleep Quality in Pregnant Women Diagnosed With Preeclampsia in the Clinic
- ClinicalTrials.gov ID
- NCT06315985
- Acronym / sponsor ID
- GAksoy
- Conditions
- Pre-Eclampsia
- Keywords
- Pre-Eclampsia, Classical Turkish Music, Sleep Quality, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsiaThis was a parallel group, randomized controlled trial. Experimental Group will listen to the music for three days. |
| Control Group | No intervention | –Control Group will take routine care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsiaAlso: Experimental group: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. | Other | Experimental Group |
Primary outcome
Perceived Stress
Time frame: 15-30 minutes
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.
1 secondary outcome
Sleep Quality
Time frame: 15-30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 32443079Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.
- Background: PubMed 24150027Hypertension 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.
- Background: PubMed 16287051Chang 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.
- Background: PubMed 25995814Dag 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.
- Background: PubMed 25628568Hansson 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.
- Background: PubMed 35177222Jung 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.
- Background: PubMed 29510179Reutrakul 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.
- Background: PubMed 29983417Spehar 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.
- Background: PubMed 30712425Thilaganathan B, Kalafat E. Cardiovascular System in Preeclampsia and Beyond. Hypertension. 2019 Mar;73(3):522-531. doi: 10.1161/HYPERTENSIONAHA.118.11191.
- Background: PubMed 19713801Yang 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.
- Background: PubMed 22906914Akolekar 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.
- Gourounti C, Karpathiotaki N, Vaslamatzis G. Psychosocial stress in high risk pregnancy. Int Arch Med. 2015;8:1-9.Link provided by the sponsor.
- United Nations Population Fund, 2023, Trends in Maternal Mortality 2000-2020, Estşmates by WHO, UNİCEF, UNFPA, World Bank Group and UNDESA/ Population DivisionLink provided by the sponsor.
- WHO, 2020Link provided by the sponsor.
- World Health Organization, 2023, Trends in maternal mortality 2000 to 2020: estimates by WHO, UNICEF, UNFPA, World Bank Group and UNDESA/Population DivisionLink provided by the sponsor.
- World Health Organization, UNICEF, United Nations Population Fund and The World Bank, Trends in Maternal Mortality: 2000 to 2020 WHO, Geneva, 2023.Link provided by the sponsor.
- Yüksekol, Ö. D., \& Başer, M. (2020). Preeklampsili Gebelerde Tamamlayıcı Ve Bütünleşik Terapilerin Kullanımı. Turkish Journal of Science and Health, 1(2), 79-83Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eylem Toker contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia in people with Pre-Eclampsia, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülay Aksoy (+905518627438, 220931003@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress (time frame: 15-30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315985, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.