PainNCT05301374
The Effect of Cartoon Watching During Central Venous Catheter Dressing Changes in Children With Cancer
A study testing Watching Cartoon in people with Pain and Anxiety, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
Many medical interventions, including dressing change of central venous catheters, can cause anxiety and pain in children with cancer. The aim of this study is to determine the effect of cartoon watching technique on anxiety and pain during central venous catheter dressing changes in children with cancer. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- What is being tested?
- Watching Cartoon
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5-12 years old
- a cancer diagnosis
- having a central venous catheter
- not having taken any analgesics in the 6 hours before the procedure
- not having any visual or auditory problems that prevent watching cartoons
- being suitable motor development and cognitive level for watching cartoons
- being a child and parent volunteering to participate in the study
- the absence of any health problems that prevent communication in the parent and the child
Who cannot join
- the reporting of pain for another reason at the time of the central venous catheter dressing changes
- being of neutropenia
- being in a terminal phase of the disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cartoon Watching on Anxiety and Pain During Central Venous Catheter Dressing Changes in Children With Cancer: A Randomized Controlled Trial
Many medical interventions, including dressing change of central venous catheters, can cause anxiety and pain in children with cancer. The aim of this study is to determine the effect of cartoon watching technique on anxiety and pain during central venous catheter dressing changes in children with cancer.
Read the detailed description
This was a parallel randomized controlled trial with 80 children with cancer. They were randomly assigned to one of two groups, including 40 children in the control group and 40 children in the cartoon group.
Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during and after central venous catheter dressing changes, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after the procedure.
The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended.
No intervention was performed to reduce anxiety and pain for children in the control group.
Parent was with their children during the procedure in both groups.
- Being tested
- Watching Cartoon
- Keywords
- Anxiety, Cancer, Cartoon, Central Venous Catheter, Child, Pain
- Medical subject headings
- Pain, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching CartoonBehavioural
Children in the cartoon group before the procedure, they chose one of the cartoons predetermined by the researchers. The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended.
| Study group | Role | What they receive |
|---|---|---|
| Cartoon Group | Experimental | Children in the cartoon group before the procedure, they chose one of the cartoons predetermined by the researchers. The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended. Parent was with their children during the procedure in both groups. Receives: Behavioral: Watching Cartoon |
| Control Group | No intervention | No intervention was performed to reduce anxiety and pain for children in the control group. Parent was with their children during the procedure in both groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
Each child's pain during and after the procedure was evaluated with the "Wong Baker Faces Pain Rating Scale" by the child. The scale consists of faces ranging from no hurt (0) to hurts worst (10)
Measured: 4 MONTHS
Secondary outcomes (3)
Children's Fear Scale
Each child's anxiety was evaluated with the "Children's Fear Scale" before, during and after the procedure by the child. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
Measured: 4 MONTHS
Heart Rate
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure and after the procedure using a pulse oximeter device.
Measured: 4 MONTHS
Oxygen Saturation
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher before the procedure, during the procedure and after the procedure using a pulse oximeter device.
Measured: 4 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Dec 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar BEKAR, Mehmet Akif Ersoy University
- Investigators
- Emine EFE, Prof.Dr., Study director, Akdeniz University, Department of Child Health and Disease Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301374
- Sponsor's protocol ID
- KAEK-610
- Status last verified
- Aug 2022
- First submitted
- 20 Mar 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cartoon Watching on Anxiety and Pain During Central Venous Catheter Dressing Changes in Children With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05301374
- Acronym / sponsor ID
- KAEK-610
- Keywords
- Anxiety, Cancer, Cartoon, Central Venous Catheter, Child, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 29 Mar 2022 (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.
Many medical interventions, including dressing change of central venous catheters, can cause anxiety and pain in children with cancer. The aim of this study is to determine the effect of cartoon watching technique on anxiety and pain during central venous catheter dressing changes in children with cancer.
Detailed description
This was a parallel randomized controlled trial with 80 children with cancer. They were randomly assigned to one of two groups, including 40 children in the control group and 40 children in the cartoon group.
Each child's anxiety was evaluated by the child using the Children's Fear Scale before, during and after central venous catheter dressing changes, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale. Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after the procedure.
The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended.
No intervention was performed to reduce anxiety and pain for children in the control group.
Parent was with their children during the procedure in both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cartoon Group | Experimental | Behavioral: Watching CartoonChildren in the cartoon group before the procedure, they chose one of the cartoons predetermined by the researchers. The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended. Parent was with their children during the procedure in both groups. |
| Control Group | No intervention | –No intervention was performed to reduce anxiety and pain for children in the control group. Parent was with their children during the procedure in both groups. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 5-12 years old
- a cancer diagnosis
- having a central venous catheter
- not having taken any analgesics in the 6 hours before the procedure
- not having any visual or auditory problems that prevent watching cartoons
Key exclusion criteria (3 listed)
- the reporting of pain for another reason at the time of the central venous catheter dressing changes
- being of neutropenia
- being in a terminal phase of the disease
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 |
|---|---|---|
| Watching CartoonChildren in the cartoon group before the procedure, they chose one of the cartoons predetermined by the researchers. The children in the cartoon group started watching a cartoon of their choice 2 minutes before the procedure and they kept watching until the procedure was ended. | Behavioural | Cartoon Group |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: 4 MONTHS
Each child's pain during and after the procedure was evaluated with the "Wong Baker Faces Pain Rating Scale" by the child. The scale consists of faces ranging from no hurt (0) to hurts worst (10)
3 secondary outcomes
Children's Fear Scale
Time frame: 4 MONTHS
Heart Rate
Time frame: 4 MONTHS
Oxygen Saturation
Time frame: 4 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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. This study is not recruiting at the moment.
Emine EFE, Prof.Dr. study director
Akdeniz University, Department of Child Health and Disease Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching Cartoon in people with Pain and Anxiety, run by Mehmet Akif Ersoy 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 8 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: finished, as of the sponsor's last update on 10 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker FACES Pain Rating Scale (time frame: 4 MONTHS). 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 10 Aug 2022.