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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:
The study will follow the CONSORT-Outcomes 2022 guideline and be registered at ClinicalTrials.gov.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hatice Kübra YURDAKUL, Msc | Contact | 0312 246 66 66 | 2078 | kubraoz86@hotmail.com |
| Cansu Akdag Topal, PhD | Contact | 0312 246 66 66 | 6675 | cansua05@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hatice Kübra YURDAKUL, Msc | Baskent University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başkent University | Recruiting | Ankara | 06790 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37903178 | Background | Acar K, Ersoz H. Effect of Guided Imagery on Patient Comfort, Vital Signs, Pain, Anxiety, and Satisfaction in Cancer Patients Undergoing Port Catheterization With Local Anesthesia: A Prospective Randomized Controlled Study. Cancer Nurs. 2024 Mar-Apr 01;47(2):93-99. doi: 10.1097/NCC.0000000000001194. Epub 2023 Oct 28. | |
| Background | Afshar, M., Mohsenzadeh, A., ve Sarafrazi, N. (2020). The effect of guided imagery on anxiety and sleep quality in hemodialysis patients: A randomized clinical trial. Qom University of Medical Sciences Journal, 13(11), 59-67. | ||
| Background | Ay, S., Parvizi, M. (2021). The Functional Assessment of Cancer Therapy General (FACT-G) Scale: Reliability and validity of Turkish version. Manisa Celal Bayar Ünivercity Journal of Institute of Health Science, 8(2), 198-203. doi:1034087/cbusbed.692556 | ||
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| ID | Term |
|---|---|
| D019018 | Imagery, Psychotherapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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|
| through study completion, an average of 1 year |
| Başkent University | Recruiting | Ankara | Turkey (Türkiye) |
| Background |
| Chirico A, Maiorano P, Indovina P, Milanese C, Giordano GG, Alivernini F, Iodice G, Gallo L, De Pietro G, Lucidi F, Botti G, De Laurentiis M, Giordano A. Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy. J Cell Physiol. 2020 Jun;235(6):5353-5362. doi: 10.1002/jcp.29422. Epub 2020 Jan 20. |
| D004191 |
| Behavioral Disciplines and Activities |