Perimenopausal WomenNCT07176611
Guided Imagery in Perimenopausal Women
A study testing Guided imagery in people with Perimenopausal Women, run by Menekşe Nazlı AKER at 1 site in Turkey (Türkiye).
Trial summary
The study will be conducted in two groups as guided imagery and control. Participants will be approached at the Public Education Center. After perimenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained… Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Women
- What is being tested?
- Guided imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 30 Nov 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 45-59 years of age
- Being in the perimenopausal period according to the Stages of Reproductive Aging Workshop (STRAW) criteria (stage +1 or +2)
- Early menopausal transition (STRAW -2): menstrual cycle length varies by 7 days or more
- Late menopausal transition (STRAW -1): amenorrhea lasting 60 days or longer
- Having entered natural menopause in postmenopausal women
- Scoring above 10 on the Women's Health Initiative Insomnia Rating Scale
Show all 10Show fewer
- Owning a smartphone
- Ability to understand and speak Turkish
- No hearing impairment
- Volunteering to participate in the study
Who cannot join
- Having received or currently receiving hormone replacement therapy
- Alcohol use
- Practicing another mind-body intervention
- Having a diagnosed disease that may cause sleep disorders and receiving medical treatment
- Having a diagnosed disease that may significantly affect quality of life and receiving medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Guided Imagery on Quality of Life and Insomnia in Perimenopausal Women
The study will be conducted in two groups as guided imagery and control. Participants will be approached at the Public Education Center. After perimenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from those who agree. Random assignment of women to the study groups will be carried out using randomization.
- Conditions
- Perimenopausal Women
- Being tested
- Guided imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imageryOther
Participants in this group will receive the guided imagery intervention. The guided imagery audio recording will be applied in a quiet room once during the initial session, and participants will be instructed to continue the practice at home before sleep for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Guided imagery | Experimental | Not described Receives: Other: Guided imagery |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
The Menopause-Specific Quality of Life Questionnaire-II (MENQOL-II) is a 29-item Likert-type scale used to assess the presence and severity of menopausal symptoms in women aged 45-59, including premenopausal, perimenopausal, postmenopausal, and surgical menopause. The scale has four subdomains: vasomotor, psychosocial, physical, and sexual. Each item is scored from 1 to 8, yielding a total score range between 29 and 232. Higher scores indicate a greater negative impact of menopausal symptoms on quality of life.
Measured: at the beginning of the study, 4 weeks and 8 weeks later
Change in Insomnia
The Women's Health Initiative Insomnia Rating Scale (WHIIRS) is a 5-item Likert-type scale used to evaluate insomnia symptoms, including sleep onset, sleep maintenance, early awakening, and sleep quality. Each item is scored between 0 and 4, with a total score ranging from 0 to 20. Higher scores indicate greater severity of insomnia
Measured: at the beginning of the study, 4 weeks and 8 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Sep 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menekşe Nazlı AKER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menekşe Nazlı AKER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176611
- Sponsor's protocol ID
- 25.06.2025-12/177
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery on Quality of Life and Insomnia in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT07176611
- Acronym / sponsor ID
- 25.06.2025-12/177
- Conditions
- Perimenopausal Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Menekşe Nazlı AKERUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 16 Sep 2025 (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 will be conducted in two groups as guided imagery and control. Participants will be approached at the Public Education Center. After perimenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from those who agree. Random assignment of women to the study groups will be carried out using randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided imagery | Experimental | Other: Guided imagery |
| Control | No intervention | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being between 45-59 years of age
- Being in the perimenopausal period according to the Stages of Reproductive Aging Workshop (STRAW) criteria (stage +1 or +2)
- Having entered natural menopause in postmenopausal women
- Scoring above 10 on the Women's Health Initiative Insomnia Rating Scale
- Owning a smartphone
Key exclusion criteria (5 listed)
- Having received or currently receiving hormone replacement therapy
- Alcohol use
- Practicing another mind-body intervention
- Having a diagnosed disease that may cause sleep disorders and receiving medical treatment
- Having a diagnosed disease that may significantly affect quality of life and receiving medical treatment
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 |
|---|---|---|
| Guided imageryParticipants in this group will receive the guided imagery intervention. The guided imagery audio recording will be applied in a quiet room once during the initial session, and participants will be instructed to continue the practice at home before sleep for eight weeks. | Other | Guided imagery |
Primary outcome
Change in Quality of Life
Time frame: at the beginning of the study, 4 weeks and 8 weeks later
The Menopause-Specific Quality of Life Questionnaire-II (MENQOL-II) is a 29-item Likert-type scale used to assess the presence and severity of menopausal symptoms in women aged 45-59, including premenopausal, perimenopausal, postmenopausal, and surgical menopause. The scale has four subdomains: vasomotor, psychosocial, physical, and sexual. Each item is scored from 1 to 8, yielding a total score range between 29 and 232. Higher scores indicate a greater negative impact of menopausal symptoms on quality of life.
Change in Insomnia
Time frame: at the beginning of the study, 4 weeks and 8 weeks later
The Women's Health Initiative Insomnia Rating Scale (WHIIRS) is a 5-item Likert-type scale used to evaluate insomnia symptoms, including sleep onset, sleep maintenance, early awakening, and sleep quality. Each item is scored between 0 and 4, with a total score ranging from 0 to 20. Higher scores indicate greater severity of insomnia
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 8 Dec 2025.
- 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 Guided imagery in people with Perimenopausal Women, run by Menekşe Nazlı AKER 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 10 inclusion and 5 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 8 Dec 2025. 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?
Change in Quality of Life (time frame: at the beginning of the study, 4 weeks and 8 weeks later). 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 8 Dec 2025.