Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

NCT ID: NCT06120764

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Chemotherapy-induced Nausea and Vomiting Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participant will be randomly assigned to groups. An independent statistician will analyze the data.

Study Groups

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Guided imagery group

Participants will receive guided imagery intervention.

Group Type EXPERIMENTAL

guided imagery

Intervention Type 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,

Control

Participants will receive routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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,

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role collaborator

Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Ayşe Ay

RN, PhD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayşe Ay, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Locations

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Hacettepe University İhsan Doğramacı Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayşe Ay, RN, PhD

Role: CONTACT

+905073560214

Yağmur Sezer Efe, RN, PhD

Role: CONTACT

+905064378562

Facility Contacts

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Şule Ünal Cangül, MD, Prof

Role: primary

+905325263749

Other Identifiers

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KA23/180

Identifier Type: -

Identifier Source: org_study_id

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