MenopauseMenopauseNCT04140240
Menopause Symptom Management in Perimenopause and Postmenopausal Period
A study testing intervention group in people with Menopause, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 18 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gülşen Ak Sözer
Antalya, Pınarbaşı Neighborhood, 07058
About this study
Official title: Effect of Progressive Muscle Relaxation Training on Menopause Symptom Management and Quality of Life
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.
Read more
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.
Read the 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.
- Conditions
- Menopause
- Being tested
- intervention group
- Keywords
- menopause management, progressive muscle relaxation, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupBehavioural
Parallel Assignment a experimental design with pre test and post test
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | Experimental: İntervention group Receives: Behavioral: intervention group |
| Control group | No intervention | Control group: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11 weeks
Secondary outcomes (1)
The Menopause Specific Quality of Life Questionnaire-MENQOL
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.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Jan 2019
- Primary completion20 Feb 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment a experimental design with pre test and post test
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülşen Ak Sözer, Akdeniz University
- Investigators
- Emel Ege, professor, Study director, Necmettin Erbakan University, Konya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140240
- Sponsor's protocol ID
- Akd04050
- Acronym
- Menopause
- Status last verified
- Jun 2020
- First submitted
- 24 Oct 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
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.
PubMed 30868921Schneider 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.
PubMed 11910611Heinemann 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.
PubMed 12914663Tao 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.
PubMed 23569361Saensak 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.
PubMed 24124377Hilditch 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.
PubMed 8844630
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Muscle Relaxation Training on Menopause Symptom Management and Quality of Life
- ClinicalTrials.gov ID
- NCT04140240
- Acronym / sponsor ID
- Menopause / Akd04050
- Conditions
- Menopause
- Keywords
- menopause management, progressive muscle relaxation, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment a experimental design with pre test and post test
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Behavioral: intervention groupExperimental: İntervention group |
| Control group | No intervention | –Control group: No intervention |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention groupParallel Assignment a experimental design with pre test and post test | Behavioural | İntervention group |
Primary outcome
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.
1 secondary outcome
The Menopause Specific Quality of Life Questionnaire-MENQOL
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- BackgroundCan Gürkan Ö; Menopoz Semptomlarını Değerlendirme Ölçeğinin Türkçe Formunun Güvenirlik ve Geçerliliği, Hemşirelik Forumu, sf:30-35, Mayıs-Haziran 2005.
- BackgroundKharbouch SB,Şahin Determination of the Quality of Life During Menopausal Stages. İ.Ü.F.N. Hem. Derg. 15 (59) : 82-90, 2007
- BackgroundChaudhuri 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
- BackgroundKaur 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
- Results publication: PubMed 30868921Johnson 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.
- Results publication: PubMed 11910611Schneider 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.
- Results publication: PubMed 12914663Heinemann 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.
- Results publication: PubMed 23569361Tao 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.
- Results publication: PubMed 24124377Saensak 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.
- Results publication: PubMed 8844630Hilditch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emel Ege, professor study director
Necmettin Erbakan University, Konya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Menopause, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale-MRS (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140240, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.