Menopausal SymptomsNCT04731402
The Effect of Acupressure, Laughter Yoga and Mindfulness on Menopausal Symptoms and Quality of Life
A study testing Acupressure, laughter yoga and mindfulness stress reduction program in people with Menopausal Symptoms and Quality of Life, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to determine the effect of acupressure, laughter yoga and Mindfulness stress reduction program on menopausal symptoms and quality of life.Menopausal period, which is one of the life stages, causes physiological changes and can decrease the quality of life. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopausal Symptoms, Quality of Life
- What is being tested?
- Acupressure, laughter yoga and mindfulness stress reduction program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2021to May 2021
- 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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- in the menopausal period
Who cannot join
- presence of psychiatric illness using psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure, Laughter Yoga and Conscious Awareness on Menopausal Symptoms and Quality of Life in Menopausal Women.
The aim of the study is to determine the effect of acupressure, laughter yoga and Mindfulness stress reduction program on menopausal symptoms and quality of life.Menopausal period, which is one of the life stages, causes physiological changes and can decrease the quality of life.
The research is a randomized controlled trial. 180 women who meet the conditions for research will be included in the study. Three instruments were used to obtain the research data: Personal Information Form,Menopausal Symptoms Rating Scale and Menopause-Specific Quality of Life Scale.
Read the detailed description
On average, one third of a woman's life passes during menopause. The menopausal period is an important period that brings many physical and psychological changes with it and significantly affects the disease process and the family and society. Cultural and ethnic characteristics of the society are among the important factors that affect women's attitudes towards menopause and the meaning of middle age for women.women seek ways to deal with menopausal symptoms.
women prefer drug-free coping methods. Mindfulness stress reduction program, yoga and laughter yoga are an alternative way to reduce menopausal symptoms.. These methods can reduce the complaints and increase the quality of life. For this reason, the effect should be determined in the menopausal period.
- Conditions
- Menopausal Symptoms, Quality of Life
- Being tested
- Acupressure, laughter yoga and mindfulness stress reduction program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure, laughter yoga and mindfulness stress reduction programOther
Initiatives will be applied to the experimental group. only measurement tools will be applied to the control group
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Acupressure group Acupressure application will be applied twice a week, 24 times in total in 12 weeks. Each acupressure point will be massaged for 30 seconds to provide circulation before compression. After the massage, pressures will be applied consecutively for 90 seconds. The session duration for each woman will be 8 minutes in total, with 2 minutes for each point in each attempt. Receives: Other: Acupressure, laughter yoga and mindfulness stress reduction program |
| Laughter Yoga | Experimental | Laughter Yoga group Laughter yoga sessions begin with gentle warm-up techniques that include stretching and stretching movements, songs, applause, and body movements. Therapy sessions are between 30-45 minutes.8 sessions of laughter yoga will be done once a week. Receives: Other: Acupressure, laughter yoga and mindfulness stress reduction program |
| mindfulness stress reduction program | Experimental | mindfulness stress reduction program mindfulness stress reduction program consists of 8 weeks. each week is 2.5 hours. each week has a different theme. There is a 6-hour silence day in the 6th week of the program. Receives: Other: Acupressure, laughter yoga and mindfulness stress reduction program |
| Control Group | No intervention | INTERVENTION NOT IMPLEMENTED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopause symptoms
Menopause Rating Scale is an 11 item scale.The five-point Likert type scale has three sub-dimensions.The higher the scores of each item, the higher the complaints, the higher the total score of the scale, the higher the menopausal complaints.
Measured: Up to 12 weeks
Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopausal quality of life
Menopausal Quality of Life Scale is a Likert-type scale with 29 questions and consists of four domains: vasomotor, psychosocial, physical and sexual. Each question score is from 0 to 6. The increase in the scale score indicates that the severity of the complaints increased.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal SymptomsStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Randomised
- Intervention model
- Single group
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Unver, PhD, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731402
- Sponsor's protocol ID
- inonu university ethics
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 1 Feb 2021
- 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 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure, Laughter Yoga and Conscious Awareness on Menopausal Symptoms and Quality of Life in Menopausal Women.
- ClinicalTrials.gov ID
- NCT04731402
- Acronym / sponsor ID
- inonu university ethics
- Conditions
- Menopausal Symptoms, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 1 Feb 2021 (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.
The aim of the study is to determine the effect of acupressure, laughter yoga and Mindfulness stress reduction program on menopausal symptoms and quality of life.Menopausal period, which is one of the life stages, causes physiological changes and can decrease the quality of life.
The research is a randomized controlled trial. 180 women who meet the conditions for research will be included in the study. Three instruments were used to obtain the research data: Personal Information Form,Menopausal Symptoms Rating Scale and Menopause-Specific Quality of Life Scale.
Detailed description
On average, one third of a woman's life passes during menopause. The menopausal period is an important period that brings many physical and psychological changes with it and significantly affects the disease process and the family and society. Cultural and ethnic characteristics of the society are among the important factors that affect women's attitudes towards menopause and the meaning of middle age for women.women seek ways to deal with menopausal symptoms.
women prefer drug-free coping methods. Mindfulness stress reduction program, yoga and laughter yoga are an alternative way to reduce menopausal symptoms.. These methods can reduce the complaints and increase the quality of life. For this reason, the effect should be determined in the menopausal period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Other: Acupressure, laughter yoga and mindfulness stress reduction programAcupressure group Acupressure application will be applied twice a week, 24 times in total in 12 weeks. Each acupressure point will be massaged for 30 seconds to provide circulation before compression. After the massage, pressures will be applied consecutively for 90 seconds. The session duration for each woman will be 8 minutes in total, with 2 minutes for each point in each attempt. |
| Laughter Yoga | Experimental | Other: Acupressure, laughter yoga and mindfulness stress reduction programLaughter Yoga group Laughter yoga sessions begin with gentle warm-up techniques that include stretching and stretching movements, songs, applause, and body movements. Therapy sessions are between 30-45 minutes.8 sessions of laughter yoga will be done once a week. |
| mindfulness stress reduction program | Experimental | Other: Acupressure, laughter yoga and mindfulness stress reduction programmindfulness stress reduction program mindfulness stress reduction program consists of 8 weeks. each week is 2.5 hours. each week has a different theme. There is a 6-hour silence day in the 6th week of the program. |
| Control Group | No intervention | –INTERVENTION NOT IMPLEMENTED |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- in the menopausal period
Key exclusion criteria (1 listed)
- presence of psychiatric illness using psychiatric medication
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 |
|---|---|---|
| Acupressure, laughter yoga and mindfulness stress reduction programInitiatives will be applied to the experimental group. only measurement tools will be applied to the control group | Other | Acupressure, Laughter Yoga, mindfulness stress reduction program |
Primary outcome
Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopause symptoms
Time frame: Up to 12 weeks
Menopause Rating Scale is an 11 item scale.The five-point Likert type scale has three sub-dimensions.The higher the scores of each item, the higher the complaints, the higher the total score of the scale, the higher the menopausal complaints.
Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopausal quality of life
Time frame: Up to 12 weeks
Menopausal Quality of Life Scale is a Likert-type scale with 29 questions and consists of four domains: vasomotor, psychosocial, physical and sexual. Each question score is from 0 to 6. The increase in the scale score indicates that the severity of the complaints increased.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Menopausal Symptoms
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruitingPhase 4
Migraine Menopause Study
Migraine, Menopausal
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure, laughter yoga and mindfulness stress reduction program in people with Menopausal Symptoms and Quality of Life, run by Inonu 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 1 inclusion and 1 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 1 Feb 2021. 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?
Acupressure, Laughter Yoga and mindfulness stress reduction program Effects on menopause symptoms (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. 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 1 Feb 2021.