Guided Imagery of the Gynecological Cancer

Sponsor
Baskent University
Study ID
NCT07408349
Status
Recruiting
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Conditions

  • Gynecologic Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • guided imagery — BEHAVIORAL
    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

Study Details

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.

Key Dates

First listed
Feb 13, 2026
Start date
Jan 19, 2026
Status verified
Feb 2026
Primary completion
Jun 10, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

The Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

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