Guided Imagery of the Gynecological Cancer

February 10, 2026 updated by: Baskent University

The Effect of Guided Imagery on Nausea, Vomiting, Anxiety and Quality of Life in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

The goal of this randomized controlled trial is to evaluate the effectiveness of a guided imagery intervention in women receiving chemotherapy for gynecological cancers at Başkent University Ankara Hospital Outpatient Chemotherapy Unit.

The main questions it aims to answer are:

Does guided imagery improve psychological or physical outcomes during chemotherapy? How do outcomes differ between the intervention (guided imagery) and control (standard information) groups?

Researchers will compare both groups to assess the effect of guided imagery across three repeated measurements.

Participants will:

  • Be randomly assigned (1:1) to intervention or control groups via an online randomization tool.
  • Complete outcome assessments at three time points.
  • Be part of a sample of 158 women (minimum 76 per group), based on power analysis for repeated measures ANOVA (effect size f = 0.25, 95% power, 95% confidence).

The study will follow the CONSORT-Outcomes 2022 guideline and be registered at ClinicalTrials.gov.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gynecological cancers are among the most common cancers in women after breast cancer. According to GLOBOCAN (2022), 1.3 million new gynecological cancer cases were reported worldwide. In Turkey, the incidence of female reproductive organ cancers is 23.8%, with endometrial, ovarian, and cervical cancers being the most common.

Treatment methods include surgery, chemotherapy, and radiotherapy, with platinum-based chemotherapy regimens widely preferred. However, chemotherapy causes numerous side effects such as nausea-vomiting, fatigue, anxiety, depression, and decreased quality of life. Complementary and alternative medicine approaches have been reported as effective in managing these symptoms.

One mind-body based complementary method, guided imagery, aims to help individuals achieve relaxation, cope with stress, and experience physical comfort through mental imagery. Developed by Lerner, this technique uses themes such as "meadow, mountain, stream, home, and close relative." Guided imagery has shown positive effects like reducing stress, enhancing immunity, alleviating nausea-vomiting, and improving quality of life.

Studies have demonstrated that guided imagery is effective in symptom management and improving psychological well-being especially in breast and gynecological cancer patients. However, research investigating the effect of this technique during chemotherapy in gynecological cancer patients is limited.

This study is designed to evaluate the effects of guided imagery on nausea, vomiting, anxiety, and quality of life in women undergoing chemotherapy for gynecological cancers.

Study Type

Interventional

Enrollment (Estimated)

46

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 Contact

Study Contact Backup

  • Name: Cansu Akdag Topal, PhD
  • Phone Number: 6675 0312 246 66 66
  • Email: cansua05@gmail.com

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Baskent University
      • Ankara, Turkey (Türkiye), 06790
        • Recruiting
        • Baskent University
        • Contact:

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

No

Description

Inclusion Criteria:

  • Having a diagnosis of another type of cancer
  • An ECOG (Eastern Cooperative Oncology Group) performance score of ≥3 (PS 3: Confined to bed for more than half of the day, limited self-care; PS 4: Completely bedridden, unable to perform self-care)

Exclusion Criteria:

  • Choosing to withdraw from the study
  • Refusing to practice guided imagery before chemotherapy 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
In the first phase, all participants will complete a Sociodemographic Data Form. The State-Trait Anxiety Inventory and FACT-G will be applied as pre- and post-tests during each of the three chemotherapy sessions. The MASCC Antiemesis Tool will be administered after the 1st session and before/after the 2nd and 3rd sessions. Participants will also self-complete the MASCC scale and a nausea-vomiting diary for seven days after each cycle. On day 7, the FACT-G will be administered via phone to evaluate changes in functional and emotional status.
Behavioral: guided imagery
Guided imagery is a method of mind-body communication, fundamentally defined as a flow of thoughts involving what we smell, taste, see, hear, and touch, or as the way our mind encodes, stores, and retrieves information. It is based on the understanding that the body and mind are interconnected and that the mind can influence the body. Stress and anxiety directly affect the brain and immune system
No Intervention: control
In each chemotherapy cycle (1st, 2nd, and 3rd), control group patients will complete the Sociodemographic Form and State-Trait Anxiety Inventory before treatment, and State-Trait Anxiety Inventory again post-treatment. They will receive the MASCC Antiemesis Scale and a nausea/vomiting diary to complete daily for 7 days. On day 7, the FACT-G and a telephone follow-up form will be administered via phone. This standardized procedure will be repeated in all three cycles to ensure consistent data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: through study completion, an average of 1 year
The Functional Assessment of Cancer Therapy-General (FACT-G) is part of the FACIT system developed to assess health-related quality of life in individuals with cancer. Due to its cancer-specific structure, FACT-G was used in this study. FACT-G Version 4 includes 27 items across four domains: Physical Well-Being (7 items), Social/Family Well-Being (7 items), Emotional Well-Being (6 items), and Functional Well-Being (7 items). Domain scores are calculated according to FACIT guidelines with adjustment for missing data. Score ranges are 0-28 for Physical, Social/Family, and Functional domains, and 0-24 for Emotional Well-Being. The total FACT-G score ranges from 0 to 108, with higher scores indicating better quality of life.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The State-Trait Anxiety Inventory (STAI)
Time Frame: through study completion, an average of 1 year
developed by Spielberger et al. (1983), assesses state and trait anxiety in individuals with or without pathology. Its Turkish validity was established by Öner and Le Compte (1983). In this study, STAI Form I was used to measure chemotherapy-related state anxiety. The inventory includes two separate 20-item scales and can be self- or interviewer-administered to individuals aged 14 and older. Responses are rated on a 4-point Likert scale. The scales include direct and reverse-coded items; reverse items are recoded before scoring. Total scores range from 20 to 80, with higher scores indicating higher anxiety levels.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Baskent University

Investigators

  • Study Director: Hatice Kübra YURDAKUL, Msc, Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 19, 2026

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYURDAKULL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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