Guided Imagery of the Gynecological Cancer
ConditionGynecologic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorBaskent University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Choosing to withdraw from the study
Refusing to practice guided imagery before chemotherapy treatment
Trial design
Design model
Parallel
Treatments tested in this trial
guided imagery
BehavioralGuided 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
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The Functional Assessment of Cancer Therapy - General (FACT-G)
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.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
The State-Trait Anxiety Inventory (STAI)
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.
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov