Clinical trial NCT05545761: The Effect of Music Therapy on Sleep Quality and Depression in Menopausal Women
Official title: The Effect of Music Therapy on Sleep Quality and Depression in Menopausal Women: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: music therapy
depression
sleep quality
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: About one-third of women experience no or mild symptoms during their menopausal life, while another third experience moderate symptoms, while the remaining one-third may experience severe symptoms.

It is stated that hormone therapy, one of the pharmacological methods, is accepted as an effective and standard method in the management of menopausal symptoms, including sleep disorders and depression, despite its side effects. However, due to the health risks associated with hormone therapy, it is stated that many women do not want to use this treatment option and turn to complementary and alternative medicine to alleviate menopausal symptoms. It is stated that physical, mental and psychological problems of women can be treated with non-pharmacological methods such as relaxation, breathing exercises, touch therapy, and music therapy as a complementary and alternative medicine approach in the world and in Turkey.

It is stated that the healing effect of music has been known among societies since ancient times. Today, with technological developments, it is stated that music does not only rest the soul, but also has a cognitively stimulating effect and a motivating effect in cases where verbal communication cannot be performed. When the national and international literature is examined, there are many studies on non-pharmacological methods for menopausal symptoms, while the effect of music therapy on depression in menopausal women was examined in only one study in Turkey. However, no study was found in which the music therapy method was used for both depression and sleep quality in menopausal women.

For this reason, the aim of the study was to determine the effect of music therapy, which is a non-pharmacological method, on sleep quality and depression in menopausal women.

Detailed description: According to WHO, the menopausal period is not a pathological process, but is expressed as one of the biological stages of a woman's life. The menopausal period is defined as the transition to old age, which begins with regression in ovarian functions and decreased reproductive capacity, and in time, reproductive ability ends.

Approximately one-third of women experience no symptoms or mild symptoms during the menopausal period, while the other third experience moderate symptoms, while the remaining one-third may experience severe symptoms. The symptomatology experienced in this period is characterized by a hypoestrogenic state that occurs due to regression in ovarian function in 60% to 80% of women . In addition to symptoms such as insomnia, vaginal dryness, irregular menstrual bleeding, depressed mood, irritability, headache, forgetfulness, and dizziness, vasomotor symptoms such as changes in body thermoregulation and night sweats can be observed in menopausal women as a result of insufficient secretion of sex hormones.

Sleep problems are defined as one of the important problems seen in menopausal women It is stated that hot flashes and especially night sweats seen in the menopausal period may cause sleep disorders with the slowdown in serotonin metabolism due to hypoestrogen. While sleep problems can negatively affect mood and activities of daily living in women, it has been reported that they have a wide-ranging negative impact on quality of life, mood, productivity and physical health, especially in women with severe sleep problems. It is stated that sleep disorders do not only affect the quality of life in women in the menopausal period, but may cause social burdens by jeopardizing their lives and health in the long run.

It is stated that depression affects approximately 350 million people worldwide and is a global burden. It is stated that depression is seen twice as often in women as in men, and that the risk of depression may increase during periods when women experience hormonal changes such as puberty, pregnancy, and transition to menopause.It is stated that the menopausal period, in which hormonal changes are experienced intensively, is not associated with psychiatric diseases alone, but the risk of its occurrence increases, especially in women in the perimenopausal period, even if there is no previous history of depressive disorder.

It is stated that hormone therapy, one of the pharmacological methods, is accepted as an effective and standard method in the management of menopausal symptoms, including sleep disorders and depression, despite its side effects. However, due to the health risks associated with hormone therapy, it is stated that many women do not want to use this treatment option and turn to complementary and alternative medicine to alleviate menopausal symptoms. It is stated that physical, mental and psychological problems of women can be treated with non-pharmacological methods such as relaxation, breathing exercises, touch therapy, and music therapy as a complementary and alternative medicine approach in the world and in Turkey.

It is stated that the healing effect of music has been known among societies since ancient times. Today, with technological developments, it is stated that music does not only rest the soul, but also has a cognitively stimulating effect and a motivating effect in cases where verbal communication cannot be performed. The importance of music therapy and its relationship with treatment was emphasized by Florence Nightingale in the early 1800s, and it was used as a therapeutic approach, accepted the power of the use of appropriate music in the healing of patients and defined music therapy as a part of the healing process Lafcı in 2018 found that music therapy had positive effects on sleep and anxiety in women with breast cancer. Kavurmacı in 2019 found that music therapy positively affects sleep quality in their study with students. It is stated that music has a therapeutic effect on mental illnesses such as depression by regulating the stress response of the hypothalamus-pituitary-adrenal axis. According to the meta-analysis results in which music therapy studies applied to patients with digestive tumors were examined, it was determined that the sleep quality could be improved and the level of depression could be reduced in those who received music therapy. It was found that music therapy had a significant effect on sleep quality and depression in patients who applied to the psychiatry outpatient clinic due to insomnia in Iran. Koçak in 2022 found that music therapy positively affects depression in menopausal women.

When the national and international literature is examined, there are many studies on non-pharmacological methods for menopausal symptoms, while the effect of music therapy on depression in menopausal women was examined in only one study in Turkey. However, no study was found in which the music therapy method was used for both depression and sleep quality in menopausal women.

Based on this argument, a study was planned to examine the effect of music therapy on sleep quality and depression in menopausal women.

Material and Method The research will be carried out with menopausal women who applied to Çayyolu No. 1 FHC between August 2022 and December 2022. The research was designed as a randomized controlled experimental study. The sample of the study was G-Power 3.1.7; By comparing the sleep quality scores between the groups, it was planned to have 35 cases in the experimental and control groups.Sampling will be done by dividing the menopausal women who apply to the FHC, who meet the inclusion criteria, into the experimental and control groups at a rate of 1/1. Considering the risk of data loss in both groups, 20% more cases will be taken.

Since the variables to be examined in our study are depression and sleep quality, the type of music to be used will be zirgüle makam and Hüseyni makam. When the effects of authorities on the human spirit are examined; It is stated that while the zirgüle maqam gives people sleep, the huseyni maqam gives people comfort . A WhatsApp group will be created with the experimental group. The links of the authority that will be played via Whatsapp will be sent.They will be asked to listen to the Hüseyni makam for at least 15 minutes at 11.00 in the morning, 5 times a week for 5 weeks, and to listen to the Zirgüle makam for at least 15 minutes at 20.00 on the same day. Feedback will be received via WhatsApp that the participants have listened to the maqam conveyed to them.Before applying music therapy in the experimental group, they will be asked to fill out the questionnaires.At the end of the music therapy application, the questionnaires made at the beginning will be applied to the experimental group again.No application will be made to the control group, and data collection forms will be applied twice with an interval of 4 weeks.

Data Collection Tools

1. Sociodemographic Information Form The first 9 questions question the participant's sociodemographic characteristics such as age, weight, height, occupation, educational status, and the next 10 questions consist of questions prepared to determine the obstetrical characteristics.While the next question was asked to detect the presence of chronic disease in the person, the last two questions were asked to detect the presence of cancer and depression.The sociodemographic information form consists of 21 questions in total.
2. Beck Depression Inventory In the study, Beck Depression Inventory will be used to evaluate the presence and severity of depression symptoms.The inventory was developed by Beck (1961) in order to express the degree of depression objectively through numbers.The Turkish adaptation of the inventory was made by Hisli (1988).For each of the 21 items that make up the inventory, there are four self-evaluation statements rated from zero to three, ranking the severity of the symptom from least to greatest.The lowest score that can be obtained from the inventory is 0 and the highest score is 63.The high total score indicates the high level of depression or its severity.In addition, a cut-off point of 17 is recommended for catching clinical depression.
3. Menopause Symptoms Rating Scale The scale was developed by the Berlin Center for Epidemiology and Health Research The validity and reliability study in Turkey was conducted by Metintaş in 2009.The 11-item Likert-type scale including menopausal complaints consists of 3 sub-dimensions.Somatic complaints sub-dimension; Items 1, 2, 3, 11, psychological complaints sub-dimension; 4th, 5th, 6th, 7th items and urogenital complaints sub-dimension; It includes items 8, 9, 10. For each item; 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe and the minimum score that can be taken from the scale is 0, and the maximum score is 44.An increase in the total score obtained from the scale indicates that both the severity of the complaints experienced and the quality of life are negatively affected.
4. Pittsburg Sleep Quality Scale (PUKÖ) It was developed by Buysse in 1989, and its validity and reliability study in Turkey was performed by Ağargün in 1996. PUKÖ consists of a total of 24 questions. 19 of the questions are self-evaluation questions, 5 of them are answered by the spouse or relative.Question 19 is not taken into account in scoring. PUKO; It consists of seven items evaluating subjective sleep quality, sleep delay, sleep duration, sleep efficiency, sleep disturbance, use of sleeping pills, and impairment in daytime work. Each component is evaluated with a score between 0-3.The scale total score is between 0-21. A PUKÖ total score of 5 and above indicates poor sleep quality.Its diagnostic sensitivity is 89.6% and its specificity is 86.5%. It takes 5-10 minutes to complete the scale

Evaluation of Data The data will be analyzed in SPSS program. Student's t test will be used for two independent group variables with normal distribution, Mann Whitney U test for data that is not normally distributed, and chi-square test for categorical variables

Eligibility criteria: Inclusion Criteria:

* Menopausal
* PSQI average score of 5 and above
* No hearing problem
* Not taking HRT at the time of the study or in the past year
* There was no diagnosis of a psychiatric disease during the study.

Exclusion Criteria:

Having communication problems, Receiving HRT treatment during the study or in the last year, Not attending music therapy sessions,

Primary outcomes:
measure: Pittsburgh sleep quality index (PUKI)
timeFrame: 5 weeks after the start of music therapy
measure: Beck Depression Scale
timeFrame: 5 weeks after the start of music therapy
measure: Menopausal Symptoms Evaluation Scale
timeFrame: 5 weeks after the start of music therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Gülhane Faculty of Health Sciences
city: Ankara
country: Turkey
facility: Meryem VURAL ŞAHİN
state: Çankaya
Study officials:
References:
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