Guided Imagery in Perimenopausal Women

December 1, 2025 updated by: Menekşe Nazlı AKER

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Guided imagery
Other: Guided imagery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the beginning of the study, 4 weeks and 8 weeks later
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
at the beginning of the study, 4 weeks and 8 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menekşe Nazlı AKER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 10, 2025

First Posted (Estimated)

September 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25.06.2025-12/177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Perimenopausal Women

Clinical Trials on Guided imagery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe