Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

Not Applicable

Recruiting

• Conditions: Pediatric Cancer; Chemotherapy-induced Nausea and Vomiting
• Interventions: Other: guided imagery

• Registration Number: NCT06120764
• Lead Sponsor: Baskent University

Brief Summary

The goal of this randomized controlled study is to assess the effect of guided imagery on chemotherapy-related nausea and vomiting in pediatric oncology patients.

Participants will receive either guided imagery+routine care or routine care. The researchers will compare nausea and vomiting and vital signs between groups.

Detailed Description

Despite significant advances in anti-emetic treatment, chemotherapy induced nausea and vomiting (CINV) is considered a major side-effect that significantly reduces the quality of life of children diagnosed with cancer. Guided imagery is one of the methods of distraction that allows the individual to go to an environment or scene that will make the individual comfortable, peaceful, happy, and focused. In this study, the participants will be randomized in a single blind manner (participant) to either intervention or control groups.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Study Start: 2023-11-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 7 to 18 years old,
• who will receive intravenous chemotherapy,
• no cognitive or neurological disease that would prevent communication,
• receiving a chemotherapy protocol with a high or moderate emetogenic effect according to the MASCC/ESMO Antiemetic Guideline Classification,
• no verbal, visual and auditory communication disabilities (ability to speak Turkish, no mental deficiency),
• children whose parents and themselves volunteered to participate in the study

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Exclusion Criteria

• Children receiving radiotherapy,
• taking ginger powder or vitamins to reduce nausea,
• children who did not want to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided imagery group	guided imagery	Participants will receive guided imagery intervention.

Primary Outcome Measures

Name	Time	Method
Nausea and vomiting	30 minutes before the procedure, halfway through the chemotherapy infusion, immediately after the procedure, and for the first 24 hours after the end of chemotherapy	Nausea and Vomiting Thermometer Scale in Children with Cancer is a 5-likert type scale. An increase in the score indicates an increase in the degree of nausea and vomiting experienced by children with cancer.

Secondary Outcome Measures

Name	Time	Method
Heart rate	30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure,	Maintaining or normalizing heart rate within normal range (60 to 110 bpm)
Systolic and diastolic blood pressure	30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure	Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-120 mmHg; diastolic 60-80 mmHg)
Respiratory rate	30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure	Maintaining or normalizing respiratory rate within normal range (18-30 breath per minute)
Body temperature	30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure	Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)
Oxygen saturation	change from baseline 60 minutes of chemotherapy infusion	Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)

Trial Locations

Locations (1)

Hacettepe University İhsan Doğramacı Hospital; 🇹🇷 Ankara, Turkey