MenopauseNCT06175962
Perımenopausal Women's Attıtudes Towards Menopause and Spırıtual Well-Beıng
A study testing TRAINING AND EXERCISE in people with Menopause and Activity, Motor, run by Sinop University at 1 site in Turkey (Türkiye).
Trial summary
Menopause; cessation of menstruation due to cessation of follicular activity is the transition from the reproductive period to non-reproductive life. Considering that the average life expectancy is increasing, women spend most of their lives in the menopausal period. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Activity, Motor, Attitude
- What is being tested?
- TRAINING AND EXERCISE
- 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
- 20 Dec 2023to 30 Aug 2024
- 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 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being in the perimenopausal period
- Being between the ages of 40-55
- Having entered menopause naturally
- Volunteering to participate in research
Who cannot join
- Having a physical problem that prevents exercise
- Being on hormone therapy
- Not having a menstrual period for more than 8 months
- Not using a smartphone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of The Menopause Adaptatıon Program Developed Based on Meleıs' Transıtıon Theory, on The Attıtudes Towards Menopause And Spırıtual Well-Beıng of Perımenopusal Women
Menopause; cessation of menstruation due to cessation of follicular activity is the transition from the reproductive period to non-reproductive life. Considering that the average life expectancy is increasing, women spend most of their lives in the menopausal period. Women who have a positive attitude towards menopause have a positive body image, experience less depressive experiences, and the severity of menopause symptoms decreases. It has also been assumed that spiritual well-being is effective in reducing the severity of menopause symptoms and anxiety, supporting positive body image, and coping with losses.
Baduanjin exercise is a type of body mind exercise. It increases the production of life energy and distributes it to different aspects of the body.
It is thought that the baduanjin body-mind exercise to be applied to perimenopausal women will have positive effects on the spiritual well-being of menopausal women and their attitudes towards menopause. Thus, it is expected that women's transition and adaptation to the menopause process will be easier.
Read the detailed description
This study will be carried out as a pre-test - post-test randomized controlled experimental study. The population of the research consists of female patients between the ages of 45-55 who are registered to a family health center located in a provincial center in the north of Turkey. Women who are in the perimenopausal period and meet the inclusion criteria according to the Staging of Reproductive Aging in Women (STRAW) criteria will be included in the study. The random.org program will be used to unbiasedly assign 60 women who meet the research criteria to the experimental and control groups.
The menopause adaptation program will be applied to the intervention regimen. This program, which will be applied to the experimental group, was prepared based on the Meleisin Transition theory. Since women's menopause is a transition process, the transition theory was preferred. Within the scope of the program, the experimental group will be given online menopause health education for the first 6 weeks and baduanjin exercise will be taught. For the next 8 weeks, individuals will be asked to practice the baduanjin exercise 3 times a week. Online consultation will be provided during this period.
The study will be completed in 14 weeks in total. No intervention will be applied to the control group. The study will be terminated after the post-test data is collected. Data will be collected using the Introductory Information Form, the Attitudes Towards Menopause Scale (MITÖ, Spirituality Index of Well-Being Scale).
- Conditions
- Menopause, Activity, Motor, Attitude
- Being tested
- TRAINING AND EXERCISE
- Keywords
- Perimenopause, Baduanjin, Menopause attitude
- Medical subject headings
- Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAINING AND EXERCISEBehavioural
Menopause health training will take place in 2 sessions each week and will be completed in 4 sessions. Each session duration is 45 minutes. Baduanjin exercise training will take place in 2 sessions per week, each session lasting 30 minutes. It will be completed in 8 sessions in total. Relaxing music will be played during the Baduanjin exercise and relaxation will be encouraged. During the Baduanjin exercise, proper posture, conscious breathing and focus of the mind will be prioritized. While the movements are being implemented, their symbolic meanings will be explained to the participants. Women will be asked to perform baduanji 3 times a week for 8 weeks.
During this process, reminder messages will be sent to women via WhatsApp.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | At the beginning of the research, the Introductory Information Form, the Attitudes Towards Menopause Scale (MITÖ), and the Spirituality Index Well-Being Scale will be applied to the experimental group. Later, menopause health education will be given to women within the scope of the menopause adaptation program prepared based on Meleis's transition theory. Then, the women will be taught the baduanjin exercise for 4 weeks by the researcher who has a Qigong practitioner certificate. All training will be held online. After making sure that the women have learned the baduanjin exercise, they will be asked to do the baduanjin exercises at home 3 times a week for 8 weeks.
During this process, counseling services will be provided and women will be followed. The study will be completed in 14 weeks, after which posttest data will be collected. Receives: Behavioral: TRAINING AND EXERCISE |
| Control Group | No intervention | At the beginning of the research, the Introductory Information Form, Attitudes Towards Menopause Scale (MITÖ), and Spirituality Index Scale will be applied to the control group. No intervention will be made to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude Scale towards Menopause (MITÖ)
It was developed by Uçanok (1994) to measure the attitudes of women in different age groups towards menopause and its aftermath. There are a total of 20 statements in the scale, 2 positive and 18 negative. The scale is a four-point Likert type. For negative expressions, scoring is done in the opposite direction. The lowest score that can be obtained from the scale is 0 and the highest score is 80. It is accepted that the higher the scores above the average score of 40, the more positive the attitude.
Measured: 14 WEEKS
Secondary outcomes (1)
Spirituality Index of Well-Being Scale
Keskinoğlu et al. (2019) conducted the Turkish validity and reliability study of the scale developed by Daaleman and Frey (2004). The scale is a 5-point Likert type consisting of 2 sub-dimensions and 12 items. All items of the scale, which have sub-dimensions of self-efficacy 1, 2, 3, 4, 5, 6 (6 items) and Life schema 7, 8, 9, 10, 11, 12 (6 items), were prepared in reverse and scored in reverse. A high score from each sub-dimension of the scale shows that the individual has the characteristic evaluated by the relevant sub-dimension. The scale also gives a total well-being score. An increase in the scale score indicates an increase in spiritual well-being. When scoring the scale, the average of the sub-dimensions and the total score is taken.
Measured: 14 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start20 Dec 2023
- Primary completion15 Feb 2024
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aynur ATAMAN KUFACI, Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175962
- Sponsor's protocol ID
- SINOPUakufaci
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Menopause Adaptatıon Program Developed Based on Meleıs' Transıtıon Theory, on The Attıtudes Towards Menopause And Spırıtual Well-Beıng of Perımenopusal Women
- ClinicalTrials.gov ID
- NCT06175962
- Acronym / sponsor ID
- SINOPUakufaci
- Conditions
- Menopause, Activity, Motor, Attitude
- Keywords
- Perimenopause, Baduanjin, Menopause attitude
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 19 Dec 2023 (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.
Menopause; cessation of menstruation due to cessation of follicular activity is the transition from the reproductive period to non-reproductive life. Considering that the average life expectancy is increasing, women spend most of their lives in the menopausal period. Women who have a positive attitude towards menopause have a positive body image, experience less depressive experiences, and the severity of menopause symptoms decreases. It has also been assumed that spiritual well-being is effective in reducing the severity of menopause symptoms and anxiety, supporting positive body image, and coping with losses.
Baduanjin exercise is a type of body mind exercise. It increases the production of life energy and distributes it to different aspects of the body.
It is thought that the baduanjin body-mind exercise to be applied to perimenopausal women will have positive effects on the spiritual well-being of menopausal women and their attitudes towards menopause. Thus, it is expected that women's transition and adaptation to the menopause process will be easier.
Detailed description
This study will be carried out as a pre-test - post-test randomized controlled experimental study. The population of the research consists of female patients between the ages of 45-55 who are registered to a family health center located in a provincial center in the north of Turkey. Women who are in the perimenopausal period and meet the inclusion criteria according to the Staging of Reproductive Aging in Women (STRAW) criteria will be included in the study. The random.org program will be used to unbiasedly assign 60 women who meet the research criteria to the experimental and control groups.
The menopause adaptation program will be applied to the intervention regimen. This program, which will be applied to the experimental group, was prepared based on the Meleisin Transition theory. Since women's menopause is a transition process, the transition theory was preferred. Within the scope of the program, the experimental group will be given online menopause health education for the first 6 weeks and baduanjin exercise will be taught. For the next 8 weeks, individuals will be asked to practice the baduanjin exercise 3 times a week. Online consultation will be provided during this period.
The study will be completed in 14 weeks in total. No intervention will be applied to the control group. The study will be terminated after the post-test data is collected. Data will be collected using the Introductory Information Form, the Attitudes Towards Menopause Scale (MITÖ, Spirituality Index of Well-Being Scale).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: TRAINING AND EXERCISEAt the beginning of the research, the Introductory Information Form, the Attitudes Towards Menopause Scale (MITÖ), and the Spirituality Index Well-Being Scale will be applied to the experimental group. Later, menopause health education will be given to women within the scope of the menopause adaptation program prepared based on Meleis's transition theory. Then, the women will be taught the baduanjin exercise for 4 weeks by the researcher who has a Qigong practitioner certificate. All training will be held online. After making sure that the women have learned the baduanjin exercise, they will be asked to do the baduanjin exercises at home 3 times a week for 8 weeks. During this process, counseling services will be provided and women will be followed. The study will be completed in 14 weeks, after which posttest data will be collected. |
| Control Group | No intervention | –At the beginning of the research, the Introductory Information Form, Attitudes Towards Menopause Scale (MITÖ), and Spirituality Index Scale will be applied to the control group. No intervention will be made to the control group. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being in the perimenopausal period
- Being between the ages of 40-55
- Having entered menopause naturally
- Volunteering to participate in research
Key exclusion criteria (4 listed)
- Having a physical problem that prevents exercise
- Being on hormone therapy
- Not having a menstrual period for more than 8 months
- Not using a smartphone
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 |
|---|---|---|
| TRAINING AND EXERCISEMenopause health training will take place in 2 sessions each week and will be completed in 4 sessions. Each session duration is 45 minutes. Baduanjin exercise training will take place in 2 sessions per week, each session lasting 30 minutes. It will be completed in 8 sessions in total. Relaxing music will be played during the Baduanjin exercise and relaxation will be encouraged. During the Baduanjin exercise, proper posture, conscious breathing and focus of the mind will be prioritized. While the movements are being implemented, their symbolic meanings will be explained to the participants. Women will be asked to perform baduanji 3 times a week for 8 weeks. During this process, reminder messages will be sent to women via WhatsApp. | Behavioural | Experimental Group |
Primary outcome
Attitude Scale towards Menopause (MITÖ)
Time frame: 14 WEEKS
It was developed by Uçanok (1994) to measure the attitudes of women in different age groups towards menopause and its aftermath. There are a total of 20 statements in the scale, 2 positive and 18 negative. The scale is a four-point Likert type. For negative expressions, scoring is done in the opposite direction. The lowest score that can be obtained from the scale is 0 and the highest score is 80. It is accepted that the higher the scores above the average score of 40, the more positive the attitude.
1 secondary outcome
Spirituality Index of Well-Being Scale
Time frame: 14 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- 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.
Aynur ATAMAN KUFACI principal investigator
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAINING AND EXERCISE in people with Menopause and Activity, Motor, run by Sinop 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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?
Results are not available in the source record.
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?
Attitude Scale towards Menopause (MITÖ) (time frame: 14 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.