Clinical trial · Interventional
Guided Imagery of the Gynecological Cancer
The Effect of Guided Imagery on Nausea, Vomiting, Retching, Anxiety and Quality of Life in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 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 minimum sample of 48 women (24 participants per group), based on the power analysis. The study will follow the CONSORT-Outcomes 2022 guideline and be registered at ClinicalTrials.gov.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| guided imagery | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Behavioral: guided imagery
- type
- NO_INTERVENTION
- label
- control
- description
- 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.
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDAcar 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
- BACKGROUNDAfshar, 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.
- BACKGROUNDAy, 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
- BACKGROUNDChirico 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