Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120764
• Other study ID #: KA23/180
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: November 2023
• Source: Baskent University
• Contact: Ayse Ay, RN, PhD
• Phone: +905073560214
• Email: ayse0526[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Pediatric Cancer
• Vomiting

Intervention

Other:
• guided imagery
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.

Locations

Country	Name	City	State
Turkey	Hacettepe University Ihsan Dogramaci Hospital	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Baskent University	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate	Maintaining or normalizing heart rate within normal range (60 to 110 bpm)	change from baseline 60 minutes of chemotherapy infusion
Secondary	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
Secondary	Respiratory rate	Maintaining or normalizing respiratory rate within normal range (18-30 breath per minute)	change from baseline 60 minutes of chemotherapy infusion
Secondary	Body temperature	Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)	change from baseline 60 minutes of chemotherapy infusion
Secondary	Oxygen saturation	Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)	change from baseline 60 minutes of chemotherapy infusion