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NCT Number: NCT06120764

Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

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.

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Key information

Conditions

Chemotherapy-induced Nausea and Vomiting Neoplasms Pathological Conditions, Signs and Symptoms Pediatric Cancer Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University İhsan Doğramacı Hospital

Ankara, 06100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Şule Ünal Cangül, MD, Prof

CONTACT

[email protected]

+905325263749

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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,

Primary outcomes

  1. 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

    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 outcomes

  1. Heart rate

    Time frame: 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)

  2. Systolic and diastolic blood pressure

    Time frame: 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)

  3. Respiratory rate

    Time frame: 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)

  4. Body temperature

    Time frame: 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)

  5. Oxygen saturation

    Time frame: change from baseline 60 minutes of chemotherapy infusion

    Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Ay, RN, PhD

CONTACT

[email protected]

+905073560214

Yağmur Sezer Efe, RN, PhD

CONTACT

[email protected]

+905064378562

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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