Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

NCT06120764 | Recruiting

• 1 other identifier: KA23/180
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting; Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Heart rate

  30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure,

• Systolic and diastolic blood pressure

  30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure

• Respiratory rate

  30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure

• Body temperature

  30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure

• Oxygen saturation

  change from baseline 60 minutes of chemotherapy infusion

Study Arms (2)

Guided imagery group

EXPERIMENTAL

Participants will receive guided imagery intervention.

Other: guided imagery

Control

NO INTERVENTION

Participants will receive routine care.

Interventions

guided imagery OTHER

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,

Guided imagery group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hacettepe University: collaborator
• Baskent University: lead

Study Sites (1)

Hacettepe University İhsan Doğramacı Hospital

Ankara, Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Vomiting; Neoplasms

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ayşe Ay, RN, PhD

  Baskent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Ay, RN, PhD

CONTACT

+905073560214; ayse0526@gmail.com

Yağmur Sezer Efe, RN, PhD

CONTACT

+905064378562; ysezerefe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will be randomly assigned to groups. An independent statistician will analyze the data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Assistant Professor

Model Details: The children in the experimental group will listen to the "Guided Imagery CD" prepared by the Turkish Psychological Association for relaxation 30 minutes before the chemotherapy infusion started and during the chemotherapy infusion. In the meantime, patients will be encouraged to think of various images, such as imagining that the treatment is over, returning to their old life quickly, etc.

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: November 10, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)