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Menopause Symptom Management in Perimenopause and Postmenopausal Period (Menopause)

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ClinicalTrials.gov Identifier: NCT04140240
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Gülşen Ak Sözer, Akdeniz University

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.


Condition or disease Intervention/treatment Phase
Menopause Behavioral: intervention group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment a experimental design with pre test and post test
Masking: Single (Outcomes Assessor)
Masking Description: Parallel Assignment a experimental design with pre test and post test
Primary Purpose: Supportive Care
Official Title: Effect of Progressive Muscle Relaxation Training on Menopause Symptom Management and Quality of Life
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : February 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: İntervention group
Experimental: İntervention group
Behavioral: intervention group
Parallel Assignment a experimental design with pre test and post test

No Intervention: Control group
Control group: No intervention



Primary Outcome Measures :
  1. Menopause Rating Scale-MRS [ Time Frame: 11 weeks ]
    Menopause Rating Scale, was first developed by Schneider et al. in 1992 to measure the severity of menopausal symptoms and their impact on quality of life. The Turkish validity and reliability of the scale was made by Gürkan (Gürkan, 2005). The total score of the scale is calculated based on the scores given for each item. The minimum score that can be obtained from the scale is 0 and the maximum score is 44. The increase in the total score obtained from the scale indicates the increase in the severity of the complaints on the one hand and the negative effect on the quality of life on the other. The 11-week progressive muscle relaxation exercises program was applied only to the intervention group. The statistically significant decrease in the mean scores of menopause rating scale in the post test in the intervention group is the success criterion of the study. Significance level is determined at p <0.05 in the analyzes.


Secondary Outcome Measures :
  1. The Menopause Specific Quality of Life Questionnaire-MENQOL [ Time Frame: 11 weeks ]
    Hilditch et al. (1996) to assess the quality of life of women in menopausal period and was standardized. Its validity and reliability in Turkish was made by Kharbouch and Şahin (2007). The Menopausal Quality of Life Scale is a Likert-type scale with 29 questions. As the score increases, the severity of the complaint increases. The lowest score that can be obtained from the total of the scale is 0 and the highest score (29X6) is 154.. However, the total score is not evaluated. MENQOL consists of four sub-scale. The higher the scores, the lower the quality of life. At the end of 11 weeks of progressive muscle relaxation exercise, scores are expected to decrease significantly in the intervention group. The significant decrease in post test scores as a result of the intervention is the success criteria of the study. Significance level is set at p<0.05 in analyzes.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140240


Contacts
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Contact: Gülşen Ak Sözer, lecturer 05322088905 gulsenak@akdeniz.edu.tr
Contact: Emel Ege, Professor 0533 775 5519 emelege@hotmail.com

Locations
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Turkey
Gülşen Ak Sözer Recruiting
Antalya, Pınarbaşı Neighborhood, Turkey, 07058
Contact: Gülşen Ak Sözer, lecturer    05322088905    gulsenak@akdeniz.edu.tr   
Sponsors and Collaborators
Akdeniz University
Investigators
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Study Director: Emel Ege, professor Necmettin Erbakan University, Konya

Publications of Results:
Other Publications:
Can Gürkan Ö; Menopoz Semptomlarını Değerlendirme Ölçeğinin Türkçe Formunun Güvenirlik ve Geçerliliği, Hemşirelik Forumu, sf:30-35, Mayıs-Haziran 2005.
Kharbouch SB,Şahin Determination of the Quality of Life During Menopausal Stages. İ.Ü.F.N. Hem. Derg. 15 (59) : 82-90, 2007
Chaudhuri A, Ray M, Saldanha D, Sarkar SK. Effects of progressive muscle relaxation on postmenopausal stress. Journal of the Scientifi c Society 42 (2): 62-67, 2015
Kaur P, Kaur S, Shanmugam S, Kang M. Efficacy of Yoga versus Relaxation Techniques on Climacteric Symptoms of Perimenopausal women. IOSR Journal of Dental and Medical Sciences (IOSR-JDMS) 13( 7): 32-42, 2014. www.iosrjournals.org

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Responsible Party: Gülşen Ak Sözer, lecturer, Akdeniz University
ClinicalTrials.gov Identifier: NCT04140240    
Other Study ID Numbers: Akd04050
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gülşen Ak Sözer, Akdeniz University:
menopause management
progressive muscle relaxation
nursing