Guided Imagery of the Gynecological Cancer

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (1)

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

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 2 centers

• Başkent University — Ankara
• Başkent University — Ankara

Publications

• 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

Identifiers

NCT: NCT07408349 · KYURDAKULL

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗