Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

Study Overview
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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 hematology-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, chemotherapyinduced 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.

Official Title
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Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting in Pediatric Hematology-oncology Patients: a Randomized Controlled Trial

Conditions
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Chemotherapy-induced Nausea and Vomiting, Pediatric Cancer

Intervention / Treatment
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* Other: guided imagery


Participation Criteria
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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, having a history of seizures, taking ginger powder or vitamins to reduce nausea, children who did not want to participate in the study

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The children in the experimental group will listen to the Guided Imagery CD prepared by the Turkish Psychological Association for relaxation 10 minutes before the chemotherapy infusion started and for 30 minutes after the chemotherapy infusion started.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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided imagery group<br>Participants will receive guided imagery intervention. | Other: guided imagery<br>* The experimental group will listen to Guided Imagery CD prepared by the Turkish Psychological Association for relaxation 10 minute before the chemotherapy infusion. The remained part of CD, containing relaxing music and wave sound, will be played for 30 minutes after the chemotherapy infusion starts. When the chemotherapy infusion starts, the patients will be given imagery suggestions by a researcher, together with listening CD throughout first 30 minutes of chemotherapy infusion. Participants will be encouraged to think of various images: the patient will be asked to imagine that the treatment is over, that he/she is much healthier, that he/she heals very fast, that he/she returns to his/her old life in a short time, that he/she imagines himself/herself doing whatever he/she wants to do first after recovery, and that he/she imagines an object, person, event, situation, food or anything else that will make him/her feel good.<br>|
| No Intervention: Control<br>Participants will receive routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change from baseline 60 minutes of chemotherapy infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Maintaining or normalizing heart rate within normal range (60 to 110 bpm) | change from baseline 60 minutes of chemotherapy infusion | 
| Systolic and diastolic blood pressure | Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-120 mmHg; diastolic 60-80 mmHg) | change from baseline 60 minutes of chemotherapy infusion | 
| Respiratory rate | Maintaining or normalizing respiratory rate within normal range (18-30 breath per minute) | change from baseline 60 minutes of chemotherapy infusion | 
| Body temperature | Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement) | change from baseline 60 minutes of chemotherapy infusion | 
| Oxygen saturation | Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry) | change from baseline 60 minutes of chemotherapy infusion |