Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting in Pediatric Oncology Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-induced Nausea and Vomiting; Pediatric Cancer
• Intervention / Treatment: Other: guided imagery

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşe Ay, RN, PhD; Phone Number: +905073560214; Email: ayse0526@gmail.com
• Study Contact Backup: Name: Yağmur Sezer Efe, RN, PhD; Phone Number: +905064378562; Email: ysezerefe@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06100
      • Recruiting
      • Hacettepe University İhsan Doğramacı Hospital
      • Contact: Şule Ünal Cangül, MD, Prof; Phone Number: +905325263749; Email: suleunal@hacettepe.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will receive routine care.
Experimental: Guided imagery group; Participants will receive guided imagery intervention.	Other: guided imagery; The children in the experimental group will listen to the first part of the 'Guided Imagery CD' prepared by the Turkish Psychological Association for relaxation 30 minutes before the chemotherapy infusion starts. The suggestions given in the first part of the CD will help the patients relax and focus their attention on their breathing. Patients will be positioned in a supine or semi-fowler position and will listen to the CD with headphones from a laptop. Once the chemotherapy infusion starts, relaxing light background music with the sound of a river or sea will be played based on the patients' preference, and imagery will be applied to the patients. Patients will be encouraged to think of various images, such as imagining that the treatment is over, visualizing themselves as much healthier and recovering quickly, returning to their old life, and doing whatever they want to do first after recovery. If there is an object, person, event, situation, or food that will make them feel good,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea and vomiting	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.	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baskent University
• Collaborators: Hacettepe University
• Investigators: Principal Investigator: Ayşe Ay, RN, PhD, Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms; Vomiting; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Imagery, Psychotherapy
• Other Study ID Numbers: KA23/180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the data wil be shared upon a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No