Chemotherapy-induced Nausea and VomitingNCT06120764
Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting
A study testing guided imagery in people with Chemotherapy-induced Nausea and Vomiting and Pediatric Cancer, run by Baskent University at 1 site in Turkey (Türkiye).
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 oncology patients. Participants will receive either guided imagery+routine care or routine care. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting, Pediatric Cancer
- What is being tested?
- guided imagery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2023to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Children receiving radiotherapy,
- taking ginger powder or vitamins to reduce nausea,
- children who did not want to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University İhsan Doğramacı Hospital
Ankara, Ankara, 06100
Şule Ünal Cangül, MD, Prof, +905325263749, suleunal@hacettepe.edu.tr
About this study
Official title: Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting in Pediatric Oncology Patients: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- guided imagery
- Medical subject headings
- Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided imageryOther
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,
| Study group | Role | What they receive |
|---|---|---|
| Guided imagery group | Experimental | Participants will receive guided imagery intervention. Receives: Other: guided imagery |
| Control | No intervention | Participants will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (5)
Heart rate
Maintaining or normalizing heart rate within normal range (60 to 110 bpm)
Measured: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure,
Systolic and diastolic blood pressure
Maintaining or normalizing systolic and blood pressure within normal range (systolic: 90-120 mmHg; diastolic 60-80 mmHg)
Measured: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
Respiratory rate
Maintaining or normalizing respiratory rate within normal range (18-30 breath per minute)
Measured: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
Body temperature
Maintaining or normalizing body temperature within normal range (36-37 C° in tympanic measurement)
Measured: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
Oxygen saturation
Maintaining or normalizing oxygen saturation within normal range (between 95%-100% by pulse oximetry)
Measured: change from baseline 60 minutes of chemotherapy infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start10 Nov 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Ayşe Ay, Baskent University
- Investigators
- Ayşe Ay, RN, PhD, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120764
- Sponsor's protocol ID
- KA23/180
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data wil be shared upon a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting in Pediatric Oncology Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06120764
- Acronym / sponsor ID
- KA23/180
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guided imagery group | Experimental | Other: guided imageryParticipants will receive guided imagery intervention. |
| Control | No intervention | –Participants will receive routine care. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (3 listed)
- Children receiving radiotherapy,
- taking ginger powder or vitamins to reduce nausea,
- children who did not want to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| guided imageryThe 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, | Other | Guided imagery group |
Primary outcome
Nausea and vomiting
Time frame: 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
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.
5 secondary outcomes
Heart rate
Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure,
Systolic and diastolic blood pressure
Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
Respiratory rate
Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
Body temperature
Time frame: 30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure
Oxygen saturation
Time frame: change from baseline 60 minutes of chemotherapy infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. the data wil be shared upon a reasonable request.
Related trials for Chemotherapy-induced Nausea and Vomiting
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 2
Personalized Antiemetic Regimen According to Patients' Pharmacogenetic Profile
Breast Cancer
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayşe Ay, RN, PhD principal investigator
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided imagery in people with Chemotherapy-induced Nausea and Vomiting and Pediatric Cancer, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Ay, RN, PhD (+905073560214, ayse0526@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea and vomiting (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.