NCT Number: NCT07408349
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.
Interested in participating?
Request Info18 year–90 year
Female
Interventional
Not applicable
Başkent University, Ankara, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Contact information is provided by the study sponsor or research team.
Cansu Akdag Topal, PhD
CONTACT
0312 246 66 66 ext. 6675
Hatice Kübra YURDAKUL, Msc
CONTACT
0312 246 66 66 ext. 2078
Baskent University
Other
The Effect of Guided Imagery on Nausea, Vomiting, Anxiety and Quality of Life in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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