To hear about similar clinical trials, please enter your email below
Trial Title:
Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting
NCT ID:
NCT06120764
Condition:
Chemotherapy-induced Nausea and Vomiting
Pediatric Cancer
Conditions: Official terms:
Nausea
Vomiting
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Participant will be randomly assigned to groups. An independent statistician will analyze
the data.
Intervention:
Intervention type:
Other
Intervention name:
guided imagery
Description:
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,
Arm group label:
Guided imagery group
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.
Criteria for 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
Gender:
All
Minimum age:
7 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hacettepe University İhsan Doğramacı Hospital
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Şule Ünal Cangül, MD, Prof
Phone:
+905325263749
Email:
suleunal@hacettepe.edu.tr
Start date:
November 10, 2023
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Baskent University
Agency class:
Other
Collaborator:
Agency:
Hacettepe University
Agency class:
Other
Source:
Baskent University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120764
