Clinical trial NCT05180266: Therapeutic Touch and Music in The Menopausal Period
Official title: The Effect of Therapeutic Touch and Music Listening on Sleep Quality, Menopausal Symptoms and Quality of Life in Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Menopause
Keywords: Menopausal Symptoms
Sleep Quality
Therapeutic Touch
Music listening
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 108
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: After the preliminary test is applied to the experimental groups, therapeutic touch will be applied to one group by the researcher and music listening will be applied to the other group.

Once a week for four weeks after the preliminary test data Therapeutic Touch Group; Therapeutic Touch application will be performed by the researcher at the appointed time. Each therapeutic touch will take 15 minutes, in accordance with the literature information. At the end of the fourth week, the final test data will be obtained.

Music Listening Group: After the preliminary test data, women will be asked to listen to relaxation music every day for four weeks for 30 minutes before bedtime in a comfortable environment at home. At the end of the fourth week, the final test data will be obtained.

To the Control Group; no intervention will be made to women after the preliminary test data.At the end of the fourth week, the final test data will be obtained.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Menopause is a natural phenomenon and physiological process in middle-aged women. It is noted that women most often complain of vasomotor symptoms and sleep disorders during the menopausal period, and therefore their quality of daily life is negatively affected. Reduce symptoms and improve quality of life for menopausal women they are applying for medical approaches due to the side effects of the method compared to music, yoga, aromatherapy, therapeutic massage, physical exercise, sleep hygiene education, therapeutic touch, acupressure, acupuncture and cognitive behavioral therapy as a non pharmacological methods, it is observed that they resort to such methods. Therefore, the aim of this study is to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women. Therefore, the aim of this study is to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.

Detailed description: Menopause is a long period of life characterized by the permanent termination of the menstrual cycle due to the cessation of ovarian functions. It is the most important midlife crisis in which special physical and psychological differences occur, often associated with a decrease in estrogen levels. Although the natural age of menopause varies, it usually ranges from 40 to 58 years, and the average age of menopause is accepted as 51. When the average life expectancy of women is accepted as 80 years, women spend about a third or more of their life in the postmenopausal period.

Along with the decrease in estrogen during menopause, symptoms related to hot flashes, night sweats, palpitations, irritability and sleep disorders are common. Especially sleep disorders are higher than in the premenopausal period. It has been reported that approximately 40-60% of menopausal women have sleep-related symptoms with night awakenings as the most common complaint. In the study of Lima et al. in which they included 819 climacteric women in Brazil; Deterioration in sleep quality was detected in 67% of the sample, more prominently in postmenopausal women. The most common complaints during menopause are deterioration of sleep quality and chronic insomnia. Untreated sleep disorders and menopausal symptoms adversely affect health and especially reduce quality of life. When the literature is examined, poor sleep quality and insufficient sleep duration; hormonal changes, poor physical health, obesity, cardiovascular disease, diabetes, irritability, physical and mental burnout, and poor quality of life, such as short-term and long-term outcomes. It is stated that the symptoms seen in the menopausal period negatively affect the quality of life of women.

Although the effective treatment to be used to solve the sleep problems experienced during the menopause period, reduce the menopausal symptoms and improve the quality of life is medication or hormonal therapy, the use of non-pharmacological methods is increasing due to the potential side effects of these treatments and the harm outweighing the benefit. Some of these methods are music, yoga, aromatherapy, therapeutic massage, physical exercise, sleep hygiene education, therapeutic touch, acupressure, acupuncture and cognitive behavioral therapy methods.

Therapeutic touch, which is among the non-pharmacological methods that have started to be preferred in recent years, is the interpretation of an ancient healing experience in the modern age. It is a non-invasive nursing intervention that channels energy using the hands. There are no known side effects associated with the use of therapeutic touch. Therapeutic touch is beneficial in reducing anxiety, pain and depression, and increasing relaxation and well-being.Therefore, this calming effect of therapeutic touch also facilitates falling asleep and can improve quality of life by easing menopausal symptoms. Another widely used non-pharmacological method is recital. Perceived calming music lowers catecholamine levels, respiratory rate, heart rate, and blood pressure. Therefore, by roviding physiological and psychological relaxation, music helps individuals to sleep better, reduce menopausal symptoms, and improve quality of life. In a meta analysis study, it was determined that listening to calming music effectively improved sleep quality.

When the literature was examined, no study was found that examined the effects of therapeutic touch and music listening on sleep quality, menopausal symptoms and menopausal quality of life in menopausal women. It is thought that the findings obtained from the research will contribute to the literature. Based on all these, the aim of this study is to examine the effects of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.

Purpose Of The Study The aim of the study was to investigate the effect of therapeutic touch and music listening on sleep quality, menopausal symptoms and quality of life in menopausal women.

Research Hypotheses H10: Therapeutic touch does not affect sleep quality in menopausal women H11: Therapeutic touch affects sleep quality in menopausal women H20: Therapeutic touch does not affect menopausal symptoms in menopausal women H21: Therapeutic touch affects menopausal symptoms in menopausal women H30: Therapeutic touch does not affect quality of life in menopausal women H31: Therapeutic touch affects quality of life in menopausal women H40: Music listening does not affect sleep quality in menopausal women H41: Listening to music affects sleep quality in menopausal women H50: Listening to music does not affect menopausal symptoms in menopausal women H51: Listening to music affects menopausal symptoms in menopausal women H60: Music listening does not affect quality of life in menopausal women H61: Music listening affects quality of life in menopausal women

Eligibility criteria: Inclusion Criteria:

* between the ages of 45-59
* Not taking Hormone Replacement Therapy,
* No psychiatric history,
* Women who do not use any other CAM methods will be included in the study.

Exclusion Criteria:

* Those who are in surgical menopause,
* Having auditory problems that prevent listening to music,
* Using any other TAT method,
* Women who use drugs that affect sleep (using antidepressant, antihistamine, benzodiazepan, hypnotic and narcotic drugs) will be excluded from the study.

Primary outcomes:
measure: The effect of therapeutic touch on sleep quality
timeFrame: eleven months
measure: The effect of therapeutic touch on menopausal symptoms
timeFrame: eleven months
measure: The effect of therapeutic touch on quality of life
timeFrame: eleven months
measure: The effect of listening to music on sleep quality
timeFrame: eleven months
measure: The effect of listening to music on menopausal symptoms
timeFrame: eleven months
measure: The effect of listening to music on quality of life
timeFrame: eleven months
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: FATMA KESKİN
role: PRINCIPAL_INVESTIGATOR
affiliation: Inonu University
name: YURDAGÜL YAĞMUR, Professor
role: STUDY_DIRECTOR
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