Guided Imagery of the Gynecological Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (1)

• The State-Trait Anxiety Inventory (STAI) [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 2 центра

• Başkent University — Ankara
• Başkent University — Ankara

Публикации

• 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. PMID 37903178
• 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.
• 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
• 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. PMID 31957873

Идентификаторы

NCT: NCT07408349 · KYURDAKULL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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