Postmenopausal WomenNCT04762095
The Effect of Mindfulness Stress Reduction Program on Menopausal Complaints and Quality of Life
A study testing mindfulness stress reduction program in people with Postmenopausal Women, run by NURDİLAN SENER at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- mindfulness stress reduction program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2019to 20 Jan 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being in menopause
- Not having any diagnosed psychiatric disease or using medication,
- Not using or not using hormone replacement therapy.
Who cannot join
- Having entered menopause with surgical methods,
- Not attending at least two group programs.
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. The data of the study were collected using Personal Information Form, Mindful Attention Awareness Scale (MAAS), Menopausal Symptoms Assessment Scale (MSAS) and Menopause Specific Quality of Life Scale (MYQOL).
Read the detailed description
Aim: The study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life.
Materials and Methods: Research is quasi-experimental. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. The data of the study were collected using Personal Information Form, Mindful Attention Awareness Scale (MAAS), Menopausal Symptoms Assessment Scale (MSAS) and Menopause Specific Quality of Life Scale (MYQOL). In the study, an 8-week Mindfulness Stress Reduction Program was applied to the women in the experimental group. In the study, mid-test and post-test (MAAS, MSAS, MYQOL) were applied 8 and 16 weeks after the pre-test. Descriptive statistics, independent groups t test, chi-square test, ANOVA, Mauchly's test and Cronbach Alpha analysis were used to evaluate the data.
- Conditions
- Postmenopausal Women
- Being tested
- mindfulness stress reduction program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness stress reduction programOther
mindfulness stress reduction program
| Study group | Role | What they receive |
|---|---|---|
| The Effect of mindfulness stress reduction program Quality of Life | Experimental | mindfulness stress reduction program reduces menopausal complaints. Receives: Other: mindfulness stress reduction program |
| The Effect of mindfulness stress reduction program Menopausal Symptoms | Experimental | mindfulness stress reduction program improves the quality of life of women in the menopausal period. Receives: Other: mindfulness stress reduction program |
What is being measured
The primary outcome is the main question the study is designed to answer.
mindfulness stress reduction program reduces menopausal 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 16 WEEKS
Mindfulness stress reduction program improves 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 16 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start29 Mar 2019
- Primary completion3 Sep 2019
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies 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
- Single group
- Model description
- Research is quasi-experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- NURDİLAN SENER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, NURDİLAN SENER, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762095
- Sponsor's protocol ID
- Firat
- Status last verified
- Nov 2021
- First submitted
- 13 Feb 2021
- Last updated
- 30 Nov 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 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Stress Reduction Program on Menopausal Complaints and Quality of Life
- ClinicalTrials.gov ID
- NCT04762095
- Acronym / sponsor ID
- Firat
- Conditions
- Postmenopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- NURDİLAN SENERUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 3 Sep 2019 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 21 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 study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. The data of the study were collected using Personal Information Form, Mindful Attention Awareness Scale (MAAS), Menopausal Symptoms Assessment Scale (MSAS) and Menopause Specific Quality of Life Scale (MYQOL).
Detailed description
Aim: The study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life.
Materials and Methods: Research is quasi-experimental. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. The data of the study were collected using Personal Information Form, Mindful Attention Awareness Scale (MAAS), Menopausal Symptoms Assessment Scale (MSAS) and Menopause Specific Quality of Life Scale (MYQOL). In the study, an 8-week Mindfulness Stress Reduction Program was applied to the women in the experimental group. In the study, mid-test and post-test (MAAS, MSAS, MYQOL) were applied 8 and 16 weeks after the pre-test. Descriptive statistics, independent groups t test, chi-square test, ANOVA, Mauchly's test and Cronbach Alpha analysis were used to evaluate the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Research is quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| The Effect of mindfulness stress reduction program Quality of Life | Experimental | Other: mindfulness stress reduction programmindfulness stress reduction program reduces menopausal complaints. |
| The Effect of mindfulness stress reduction program Menopausal Symptoms | Experimental | Other: mindfulness stress reduction programmindfulness stress reduction program improves the quality of life of women in the menopausal period. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being in menopause
- Not having any diagnosed psychiatric disease or using medication,
- Not using or not using hormone replacement therapy.
Key exclusion criteria (2 listed)
- Having entered menopause with surgical methods,
- Not attending at least two group programs.
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 |
|---|---|---|
| mindfulness stress reduction programmindfulness stress reduction program | Other | The Effect of mindfulness stress reduction program Menopausal Symptoms, The Effect of mindfulness stress reduction program Quality of Life |
Primary outcome
mindfulness stress reduction program reduces menopausal symptoms
Time frame: UP TO 16 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.
Mindfulness stress reduction program improves quality of life
Time frame: UP TO 16 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
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 30 Nov 2021.
- 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.
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 mindfulness stress reduction program in people with Postmenopausal Women, run by NURDİLAN SENER 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 3 inclusion and 2 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 30 Nov 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?
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?
mindfulness stress reduction program reduces menopausal symptoms (time frame: UP TO 16 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 30 Nov 2021.