Menopause Symptom Management in Perimenopause and Postmenopausal Period

NCT04140240 | Completed

• 1 other identifier: Akd04050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

menopause management; progressive muscle relaxation; nursing

Outcome Measures

Primary Outcomes (1)

• Menopause Rating Scale-MRS

  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.

  11 weeks

Secondary Outcomes (1)

• The Menopause Specific Quality of Life Questionnaire-MENQOL

  11 weeks

Study Arms (2)

İntervention group

EXPERIMENTAL

Experimental: İntervention group

Behavioral: intervention group

Control group

NO INTERVENTION

Control group: No intervention

Interventions

intervention group BEHAVIORAL

Parallel Assignment a experimental design with pre test and post test

İntervention group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Gülşen Ak Sözer

Antalya, Pınarbaşı Neighborhood, 07058, Turkey (Türkiye)

Location

Related Publications (10)

• Can Gürkan Ö; Menopoz Semptomlarını Değerlendirme Ölçeğinin Türkçe Formunun Güvenirlik ve Geçerliliği, Hemşirelik Forumu, sf:30-35, Mayıs-Haziran 2005.

  BACKGROUND

• Kharbouch SB,Şahin Determination of the Quality of Life During Menopausal Stages. İ.Ü.F.N. Hem. Derg. 15 (59) : 82-90, 2007

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.

  PMID: 30868921 RESULT

• Schneider HP, Heinemann LA, Rosemeier HP, Potthoff P, Behre HM. The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints. Climacteric. 2000 Mar;3(1):59-64. doi: 10.3109/13697130009167600.

  PMID: 11910611 RESULT

• Heinemann LA, Potthoff P, Schneider HP. International versions of the Menopause Rating Scale (MRS). Health Qual Life Outcomes. 2003 Jul 30;1:28. doi: 10.1186/1477-7525-1-28.

  PMID: 12914663 RESULT

• Tao M, Shao H, Li C, Teng Y. Correlation between the modified Kupperman Index and the Menopause Rating Scale in Chinese women. Patient Prefer Adherence. 2013;7:223-9. doi: 10.2147/PPA.S42852. Epub 2013 Mar 20.

  PMID: 23569361 RESULT

• Saensak S, Vutyavanich T, Somboonporn W, Srisurapanont M. Modified relaxation technique for treating hypertension in Thai postmenopausal women. J Multidiscip Healthc. 2013 Oct 3;6:373-8. doi: 10.2147/JMDH.S51580. eCollection 2013.

  PMID: 24124377 RESULT

• Hilditch JR, Lewis J, Peter A, van Maris B, Ross A, Franssen E, Guyatt GH, Norton PG, Dunn E. A menopause-specific quality of life questionnaire: development and psychometric properties. Maturitas. 1996 Jul;24(3):161-75. doi: 10.1016/s0378-5122(96)82006-8.

  PMID: 8844630 RESULT

Study Officials

• Emel Ege, professor

  Necmettin Erbakan University, Konya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Parallel Assignment a experimental design with pre test and post test
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Parallel Assignment a experimental design with pre test and post test

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 25, 2019
• Study Start: January 1, 2019
• Primary Completion: February 20, 2020
• Study Completion: March 18, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)