Clinical trial NCT04140240: Menopause Symptom Management in Perimenopause and Postmenopausal Period
Official title: Effect of Progressive Muscle Relaxation Training on Menopause Symptom Management and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: menopause management
progressive muscle relaxation
nursing
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment a experimental design with pre test and post test
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim:The aim of this study is to relieve menopause symptoms and improve quality of life by applying progressive muscle relaxation exercises to women in perimenopause and postmenopausal period.

Method: This study was planned as a pre-test, post-test, semi-interventional and control group study in order to relieve menopausal symptoms and to evaluate the effect on improving quality of life by applying progressive muscle relaxation exercises to women in perimenopause and postmenopausal period.

In the study, Individual Information Form, Menopause Symptom Rating Scale, Menopause Specific Quality of Life Scale were used to collect data.

The intervention group consisted of female students enrolled in GeroAtlas60 + Refresher University, which is a project of the Department of Gerontology, Faculty of Health Sciences, Akdeniz University. The Control group consisted of female students enrolled in the Mediterranean Family Health and Education Association. All female students who accepted to participate in the study and who met the inclusion criteria were included in the study. At the beginning of the study, pre-tests were applied to all participants. After 11 weeks of progressive muscle relaxation exercises, final tests were applied to the intervention group. The control group also underwent post-tests 11 weeks after any intervention. Progressive muscle relaxation exercises were then performed. After the researcher's explanation, the participants filled in the data collection forms themselves.

The post test data was collected in Jun 2019. The data will be entered in the SPSS file and the analysis of the data will be performed in the next stage.

Detailed description: This study was conducted as a pre-test, post-test, semi-interventional and control group study to evaluate the effect of progressive muscle relaxation exercises on perimenopausal and postmenopausal women to relieve menopause symptoms and improve quality of life.

According to the World Health Organization, menopause is defined as a permanent termination of menstruation due to loss of ovarian activity . Menopause is a period of life from which the reproductive ability is lost, due to the decline in ovarian function of women. If menstruation is not observed for one year at the end of the reproductive period, menopause is considered to have started. Menopausal symptoms begin to appear in the premenopausal period and the effects continue in the postmenopausal period.

It is stated that symptoms seen in perimenopausal and post menopausal period adversely affect the quality of life of women. According to the results of the study, progressive relaxation exercises in perimenopause and postmenopausal women alleviate and relieve stress, anxiety and depression, pain, hot flash, and regulate blood pressure and pulse sleep.

Ethics committee approval and institutional permissions were obtained before starting the study. Written and verbal consent was obtained from all participants. In the study, Individual Information form, Menopause Symptom Rating Scale, Menopause Specific Quality of Life Scale were used to collect data. These data collection tools were used in the pre-test and post-test.

Women students who were registered to GeroAtlas60 + Refresher University of Akdeniz University Faculty of Health Sciences Department of Gerontology were appointed as an intervention group by lot method. Female students who accepted to participate in the study were divided into five groups and pre-tests were performed. The intervention group received 45 minutes of menopause symptom management training twice a week for two weeks. Then, 45 minutes of progressive muscle relaxation exercises were performed. In the first session, the participants were given a booklet of menopause management and progressive muscle relaxation exercises prepared by the researchers. At the end of the two-week learning process, the participants were given Progressive Muscle Relaxation Exercise Guide and Progressive Muscle Relaxation Exercise Calendar. At the same time, audio recording including Menopause Management and Progressive Muscle Relaxation Exercise application, which the researcher recorded by himself, was sent via wat's up. Reminder messages were sent to the participants via wta's up to remind them to come on the application days, the application to be held in the evening and do it themselves at home.Participants performed Progressive Muscle Relaxation Exercise two days a week in the presence of researchers. They recorded the voice of the researcher at home every other day. They marked their practice on the Progressive Muscle Relaxation Exercise Calendar for 11 weeks. This marked calendar was withdrawn from the participants at the end of the 11-week practice. After 11 weeks of progressive muscle relaxation exercises, post tests were applied to the intervention group. The control group also underwent post-tests 11 weeks after any intervention. Progressive muscle relaxation exercises were then performed. After the researcher's explanation, the participants filled in the data collection forms themselves.

The post test data was collected in Jun 2019. The data will be entered in the SPSS file and the analysis of the data will be performed in the next stage.

Eligibility criteria: Inclusion Criteria:

* Being between 40-65 years
* Not having menstruated during the last year
* To be at least primary school graduate
* To have a smart mobile phone
* Menopause symptom rating scale score of 15 and above

Exclusion Criteria:

* Being under 40,
* Being over 65 years of age,
* To use hormone replacement therapy for menopause symptoms in the last six months and during the study period,
* Use complementary therapy or progressive muscle relaxation exercises in the last two months for menopausal symptoms.
* No hearing impairment
* Being diagnosed with psychiatric illness

Primary outcomes:
measure: Menopause Rating Scale-MRS
timeFrame: 11 weeks
Secondary outcomes:
measure: The Menopause Specific Quality of Life Questionnaire-MENQOL
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Gülşen Ak Sözer
state: Pınarbaşı Neighborhood
Study officials:
affiliation: Necmettin Erbakan University, Konya
name: Emel Ege, professor
role: STUDY_DIRECTOR
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