Postmenopausal SymptomsNCT05202054
Insomnia and Mindfulness Stress Reduction Program
A study testing mindfulness stress reduction program in people with Postmenopausal Symptoms, run by NURDİLAN SENER at 1 site in Turkey (Türkiye).
Trial summary
Menopause is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of… 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
- Postmenopausal Symptoms
- What is being tested?
- mindfulness stress reduction program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2022to 29 Jan 2023
- 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
- being able to read and write,
- Not having a period for at least a year,
- Not having any diagnosed psychiatric disease or not using medication,
- Not using or not using hormone replacement therapy.
Who cannot join
- To have entered menopause with surgical methods,
- Not participating in at least two group programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness Stress Reduction Program Applied to Postmenopausal Women on Insomnia and Quality of Life
Menopause is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of function of the ovaries. One of the most common and disturbing symptoms of menopause is sleep problems. Sleep is seen as an important health variable that affects an individual's quality of life and well-being. The need for sleep is included among the basic care problems by nursing theorists, and sleep-related problems are included as a nursing diagnosis in the nursing literature. In the literature, it has been stated that mindfulness stress reduction program reduces menopausal symptoms.
Nurses should have knowledge about menopause and coping methods in the field. Although the number of studies examining the effect of mindfulness stress reduction program on insomnia, which is one of the menopausal complaints, is very few in the literature.
Read the detailed description
Menopause is a medical term defined as the absence of menstrual bleeding lasting more than one year in women in a certain period of life. Menopause is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of function of the ovaries. One of the most common and disturbing symptoms of menopause is sleep problems.
Sleep is accepted as one of the basic physiological needs of humans, which covers 1/3 of human life and ensures the continuity of health. In addition to productivity and efficiency, sleep positively affects cognitive functions such as memory and concentration and contributes to physical and psychological restoration. Because of these positive effects, sleep is seen as an important health variable that affects an individual's quality of life and well-being.
The need for sleep is included among the basic care problems by nursing theorists, and sleep-related problems are included as a nursing diagnosis in the nursing literature. "Discomfort in sleep pattern", which is defined as a condition that causes discomfort in the quality and quantity of the resting pattern or affects the lifestyle, is an important nursing diagnosis that also affects the quality of life and is among the nursing diagnoses determined by NANDA (North American Nursing Diagnosis Association).
In order to cope with the problems participan experience in the menopausal period, women seek various pharmacological and non-pharmacological ways. When the studies conducted in recent years are examined, it has been determined that the commonly used complementary alternative therapies reduce the complaints experienced in menopause. One of the complementary alternative therapies is mindfulness. In the literature, it has been stated that mindfulness stress reduction program reduces menopausal symptoms.
Nurses should have knowledge about menopause and coping methods in the field. Counseling the individual and the family is among the responsibilities of the nurse. Although the number of studies examining the effect of mindfulness stress reduction program and acupuncture on insomnia, which is one of the menopausal complaints, is very few in the literature. It is thought that this study, which was designed to examine the effect of mindfulness stress reduction program on insomnia and quality of life from menopausal complaints, will provide evidence and bring innovation to nursing profession practices.
- Conditions
- Postmenopausal Symptoms
- Being tested
- mindfulness stress reduction program
- Keywords
- Menopause, Sleep, QUALITY OF LIFE, NURSING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness stress reduction programOther
Before the program is implemented, in case women forget, they will be called and reminded of the training time, and they will be invited to the program. The women in the experimental group will be administered 150 minutes of BFSAP once a week, lasting 8 weeks, and consisting of 8 times in total. Afterwards, the women will be given an intermediate test. After the midterm test, women will be asked to individually repeat their BFSAP administration in their own home for 8 weeks (weeks 8-16).
| Study group | Role | What they receive |
|---|---|---|
| The Effect of mindfulness stress reduction program on slepness and quality of life | Experimental | Groups of 20 will be formed for the implementation of the mindfulness stress reduction program in the experimental group. The BFSAP day and time will be determined by taking into account the time zones where women are available. 150 minutes of BFSAP will be applied to the women in the experimental group once a week, lasting 8 weeks and consisting of 8 times in total. The women will then be given a midterm test. After the midterm, women will be asked to individually repeat the BFSAP application in their own home for 8 weeks (weeks 8-16). Receives: Other: mindfulness stress reduction program |
| control group | No intervention | THESE PARTICIPANTS HAVE NOT BEEN APPLIED |
What is being measured
The primary outcome is the main question the study is designed to answer.
women's health initiative insomnia scale
Levine et al. (2003) the validity and reliability study of the scale in our country was done by Timur and Şahin (2009). The scale is a Likert type scale consisting of 5 questions. In the study of Timur and Şahin (2009), the Cronbach Alpha value was found to be 0.85.
Measured: UP TO 16 WEEKS
Secondary outcomes (1)
Menopause-Specific Quality of Life Scale
The scale was developed by Hilditch et al. in 1996 to measure menopause-specific quality of life. It was adapted to Turkish society by Kharbouch and Şahin in 2005 and its validity and reliability were determined. The scale is a 7-point Likert type scale consisting of 29 questions.
Each sub-domain score was scored from 0 to 6 in the MCQC. "0" points that there is no problem with that issue. A score of "1" indicates that the problem exists, but this problem is not disturbing at all, while scores between 2-6 indicate the severity and increasing levels of the existing problem. The lowest score that can be obtained from the scale is 0, the highest score is 174. The scale consists of four sub-dimensions: vasomotor, psychosocial, physical and sexual. As the score increases, the severity of the complaint increases and the quality of life decreases.
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 Jan 2022
- Study start3 Apr 2022
- Primary completion3 Dec 2022
- Study completion29 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal SymptomsStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- PRETEST POSTTEST EXPERIMENTAL RANDOMIZED STUDY
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 192 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
- NCT05202054
- Sponsor's protocol ID
- FIRAT UNIVERSTY
- Status last verified
- Apr 2023
- First submitted
- 22 Nov 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sener Cetin N, Nacar G, Timur Tashan S. The effect of mindfulness-based stress reduction program applied to postmenopausal women on insomnia and quality of life. Women Health. 2024 Aug;64(7):573-583. doi: 10.1080/03630242.2024.2382420. Epub 2024 Jul 28.
PubMed 39069644
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Stress Reduction Program Applied to Postmenopausal Women on Insomnia and Quality of Life
- ClinicalTrials.gov ID
- NCT05202054
- Acronym / sponsor ID
- FIRAT UNIVERSTY
- Conditions
- Postmenopausal Symptoms
- Keywords
- Menopause, Sleep, QUALITY OF LIFE, NURSING
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- NURDİLAN SENERUniversity, hospital or other
- Study start
- 3 Apr 2022 (actual)
- Primary completion
- 3 Dec 2022 (actual)
- Study completion
- 29 Jan 2023 (actual)
- First posted
- 21 Jan 2022 (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 is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of function of the ovaries. One of the most common and disturbing symptoms of menopause is sleep problems. Sleep is seen as an important health variable that affects an individual's quality of life and well-being. The need for sleep is included among the basic care problems by nursing theorists, and sleep-related problems are included as a nursing diagnosis in the nursing literature. In the literature, it has been stated that mindfulness stress reduction program reduces menopausal symptoms.
Nurses should have knowledge about menopause and coping methods in the field. Although the number of studies examining the effect of mindfulness stress reduction program on insomnia, which is one of the menopausal complaints, is very few in the literature.
Detailed description
Menopause is a medical term defined as the absence of menstrual bleeding lasting more than one year in women in a certain period of life. Menopause is the longest life stage in a woman's life, in which psychological and social changes are experienced as well as physical changes and some health problems occur. The symptoms of menopause develop due to varying degrees of somatic and psychological changes that occur as a result of the gradual loss of function of the ovaries. One of the most common and disturbing symptoms of menopause is sleep problems.
Sleep is accepted as one of the basic physiological needs of humans, which covers 1/3 of human life and ensures the continuity of health. In addition to productivity and efficiency, sleep positively affects cognitive functions such as memory and concentration and contributes to physical and psychological restoration. Because of these positive effects, sleep is seen as an important health variable that affects an individual's quality of life and well-being.
The need for sleep is included among the basic care problems by nursing theorists, and sleep-related problems are included as a nursing diagnosis in the nursing literature. "Discomfort in sleep pattern", which is defined as a condition that causes discomfort in the quality and quantity of the resting pattern or affects the lifestyle, is an important nursing diagnosis that also affects the quality of life and is among the nursing diagnoses determined by NANDA (North American Nursing Diagnosis Association).
In order to cope with the problems participan experience in the menopausal period, women seek various pharmacological and non-pharmacological ways. When the studies conducted in recent years are examined, it has been determined that the commonly used complementary alternative therapies reduce the complaints experienced in menopause. One of the complementary alternative therapies is mindfulness. In the literature, it has been stated that mindfulness stress reduction program reduces menopausal symptoms.
Nurses should have knowledge about menopause and coping methods in the field. Counseling the individual and the family is among the responsibilities of the nurse. Although the number of studies examining the effect of mindfulness stress reduction program and acupuncture on insomnia, which is one of the menopausal complaints, is very few in the literature. It is thought that this study, which was designed to examine the effect of mindfulness stress reduction program on insomnia and quality of life from menopausal complaints, will provide evidence and bring innovation to nursing profession practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- PRETEST POSTTEST EXPERIMENTAL RANDOMIZED STUDY
| Arm | Type | Receives |
|---|---|---|
| The Effect of mindfulness stress reduction program on slepness and quality of life | Experimental | Other: mindfulness stress reduction programGroups of 20 will be formed for the implementation of the mindfulness stress reduction program in the experimental group. The BFSAP day and time will be determined by taking into account the time zones where women are available. 150 minutes of BFSAP will be applied to the women in the experimental group once a week, lasting 8 weeks and consisting of 8 times in total. The women will then be given a midterm test. After the midterm, women will be asked to individually repeat the BFSAP application in their own home for 8 weeks (weeks 8-16). |
| control group | No intervention | –THESE PARTICIPANTS HAVE NOT BEEN APPLIED |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being able to read and write,
- Not having a period for at least a year,
- Not having any diagnosed psychiatric disease or not using medication,
- Not using or not using hormone replacement therapy.
Key exclusion criteria (2 listed)
- To have entered menopause with surgical methods,
- Not participating in 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 programBefore the program is implemented, in case women forget, they will be called and reminded of the training time, and they will be invited to the program. The women in the experimental group will be administered 150 minutes of BFSAP once a week, lasting 8 weeks, and consisting of 8 times in total. Afterwards, the women will be given an intermediate test. After the midterm test, women will be asked to individually repeat their BFSAP administration in their own home for 8 weeks (weeks 8-16). | Other | The Effect of mindfulness stress reduction program on slepness and quality of life |
Primary outcome
women's health initiative insomnia scale
Time frame: UP TO 16 WEEKS
Levine et al. (2003) the validity and reliability study of the scale in our country was done by Timur and Şahin (2009). The scale is a Likert type scale consisting of 5 questions. In the study of Timur and Şahin (2009), the Cronbach Alpha value was found to be 0.85.
1 secondary outcome
Menopause-Specific Quality of Life Scale
Time frame: up to 16 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 Apr 2023.
- Derived from this study: PubMed 39069644Sener Cetin N, Nacar G, Timur Tashan S. The effect of mindfulness-based stress reduction program applied to postmenopausal women on insomnia and quality of life. Women Health. 2024 Aug;64(7):573-583. doi: 10.1080/03630242.2024.2382420. Epub 2024 Jul 28.
- Individual participant dataSharing planned: Undecided
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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 Symptoms, 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 4 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 11 Apr 2023. 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?
women's health initiative insomnia scale (time frame: UP TO 16 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 NCT05202054, which also lists 1 linked publication.
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 Apr 2023.