NCT07176611

Brief 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 from those who agree. Random assignment of women to the study groups will be carried out using randomization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

September 10, 2025

Last Update Submit

December 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    at the beginning of the study, 4 weeks and 8 weeks later

Study Arms (2)

Guided imagery

EXPERIMENTAL
Other: Guided imagery

Control

NO INTERVENTION

Interventions

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.

Guided imagery

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Owning a smartphone
  • Ability to understand and speak Turkish
  • No hearing impairment
  • Volunteering to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdağmadeni Public Education Center

Yozgat, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Imagery, Psychotherapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

September 10, 2025

First Posted

September 16, 2025

Study Start

September 15, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations