Clinical trial NCT06120764: Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting
Official title: Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting in Pediatric Oncology Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Pediatric Cancer
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2023-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Nausea and vomiting
timeFrame: 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:
measure: Heart rate
timeFrame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure,
measure: Systolic and diastolic blood pressure
timeFrame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
measure: Respiratory rate
timeFrame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
measure: Body temperature
timeFrame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
measure: Oxygen saturation
timeFrame: change from baseline 60 minutes of chemotherapy infusion
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University İhsan Doğramacı Hospital
Study officials:
affiliation: Baskent University
name: Ayşe Ay, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: