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Recruiting NCT06120764

Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

No phase Interventional Chemotherapy-induced Nausea and Vomiting Pediatric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: guided imagery.
Who it may be relevant to
Registry conditions: Chemotherapy-induced Nausea and Vomiting, Pediatric Cancer. Basic parameters: 7 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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, re

Primary outcome measures

  • Nausea and vomiting [Time frame: 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 (5)
  • Heart rate [Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure,]
  • Systolic and diastolic blood pressure [Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure]
  • Respiratory rate [Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure]
  • Body temperature [Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure]
  • Oxygen saturation [Time frame: change from baseline 60 minutes of chemotherapy infusion]

Eligibility criteria

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

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
Double blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Hacettepe University İhsan Doğramacı Hospital — Ankara

Identifiers

NCT: NCT06120764 · KA23/180

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗