Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting

Sponsor

Baskent University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06120764

Collaborator

Hacettepe University (Other)

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Nausea and Vomiting Pediatric Cancer	Other: guided imagery	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

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 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.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 (Participant, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 5, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Mar 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guided imagery group Participants will receive guided imagery 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.
No Intervention: Control Participants will receive routine care.

Arm

Intervention/Treatment

Experimental: Guided imagery group

Participants will receive guided imagery 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.

No Intervention: Control

Participants will receive routine care.

Outcome Measures

Primary Outcome Measures

Nausea and vomiting [change from baseline 60 minutes of chemotherapy infusion]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe University İhsan Doğramacı Hospital	Ankara		Turkey	06100

Sponsors and Collaborators

Baskent University
Hacettepe University

Investigators

Principal Investigator: Ayşe Ay, RN, PhD, Baskent University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayşe Ay, RN, PhD, Assistant Professor, Baskent University

ClinicalTrials.gov Identifier:

NCT06120764

Other Study ID Numbers:

KA23/180

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nausea

Vomiting

Study Results

No Results Posted as of Nov 7, 2023