PainNCT04924023
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes in Children With Cancer
A study testing kaleidoscope application in people with Pain and Anxiety, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
Many medical interventions, including the dressing of central venous catheters, a common procedure used for children with cancer, cause anxiety and pain in children. This can adversely affect their care and recovery. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- What is being tested?
- kaleidoscope application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 May 2021
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a cancer diagnosis,
- having a central venous catheter,
- 6-12 years old,
- not having taken any analgesics in the 6 hours before the central venous catheter dressing, -being in a non-terminal phase of the disease,
- absence of neutropenia,
- volunteering to participate in the study,
- the absence of any health problems that prevent communication in the parent or the child.
Who cannot join
- -the reporting of pain for another reason at the time of the central venous catheter dressing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes on Anxiety and Pain in Children With Cancer: A Randomised Controlled Study
Many medical interventions, including the dressing of central venous catheters, a common procedure used for children with cancer, cause anxiety and pain in children. This can adversely affect their care and recovery. This study aims to determine the effect of using a kaleidoscope during central venous catheter dressing on anxiety and pain in children with cancer.
Read the detailed description
This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's anxiety was evaluated by the child using the Child Fear Scale before, during and after a central venous catheter dressing procedure, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES). Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after central venous catheter dressing.
The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
No intervention was performed to reduce pain and anxiety for children in the control group.
Parents accompanied their children during the procedure in both groups.
- Being tested
- kaleidoscope application
- Keywords
- Anxiety, Cancer, 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.
kaleidoscope applicationBehavioural
The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
| Study group | Role | What they receive |
|---|---|---|
| Kaleidoscope Group | Experimental | Children in this group were told what a kaleidoscope is and how to use it before their central venous catheter dressing. The children were then asked if they would like to look into the kaleidoscope. The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished. The kaleidoscope was disinfected before each use. A kaleidoscope was provided for all children in this group by the same researcher. Parents accompanied their children during the catheter dressing. Receives: Behavioral: kaleidoscope application |
| Control Group | No intervention | No intervention was performed to reduce pain and anxiety for children in the control group. Parents accompanied their children during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale (WB-FACES)
The Wong-Baker Faces Pain Rating Scale (WB-FACES) is used to evaluate pain levels in children. This numeric rating scale ranges from 0 to 10 and is represented by faces that display emotions ranging from smiling (0 = very happy or no pain) to crying (10 = the worst pain).
Measured: 5 MONTHS
Children's Fear Scale (CFS)
The Children's Fear Scale (CFS) is used to evaluate anxiety levels in children. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
Measured: 5 MONTHS
Secondary outcomes (2)
Heart Rate
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device.
Measured: 5 MONTHS
Oxygen Saturation
The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device.
Measured: 5 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jan 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Randomization was done using the closed-envelope method. A total of 60 cards, equally divided between the kaleidoscope and control groups (30 of each), were placed in sealed envelopes. The children were asked to choose one of these envelopes, which determined their placement in the kaleidoscope group or the control group.
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT04924023
- Sponsor's protocol ID
- KAEK-791
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bekar P, Erkul M, Efe E. The effect of using a kaleidoscope during central venous catheter dressing changes on pain and anxiety in children with cancer: A randomised controlled trial. Eur J Oncol Nurs. 2022 Apr;57:102114. doi: 10.1016/j.ejon.2022.102114. Epub 2022 Feb 25.
PubMed 35248915
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes on Anxiety and Pain in Children With Cancer: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04924023
- Acronym / sponsor ID
- KAEK-791
- Keywords
- Anxiety, Cancer, Central venous catheter, Child, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 11 Jun 2021 (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 the dressing of central venous catheters, a common procedure used for children with cancer, cause anxiety and pain in children. This can adversely affect their care and recovery. This study aims to determine the effect of using a kaleidoscope during central venous catheter dressing on anxiety and pain in children with cancer.
Detailed description
This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's anxiety was evaluated by the child using the Child Fear Scale before, during and after a central venous catheter dressing procedure, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES). Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after central venous catheter dressing.
The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
No intervention was performed to reduce pain and anxiety for children in the control group.
Parents accompanied 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
- Model description
- Randomization was done using the closed-envelope method. A total of 60 cards, equally divided between the kaleidoscope and control groups (30 of each), were placed in sealed envelopes. The children were asked to choose one of these envelopes, which determined their placement in the kaleidoscope group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Kaleidoscope Group | Experimental | Behavioral: kaleidoscope applicationChildren in this group were told what a kaleidoscope is and how to use it before their central venous catheter dressing. The children were then asked if they would like to look into the kaleidoscope. The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished. The kaleidoscope was disinfected before each use. A kaleidoscope was provided for all children in this group by the same researcher. Parents accompanied their children during the catheter dressing. |
| Control Group | No intervention | –No intervention was performed to reduce pain and anxiety for children in the control group. Parents accompanied their children during the procedure. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- a cancer diagnosis,
- having a central venous catheter,
- 6-12 years old,
- not having taken any analgesics in the 6 hours before the central venous catheter dressing, -being in a non-terminal phase of the disease,
- absence of neutropenia,
Key exclusion criteria (1 listed)
- -the reporting of pain for another reason at the time of the central venous catheter dressing.
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 |
|---|---|---|
| kaleidoscope applicationThe children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished. | Behavioural | Kaleidoscope Group |
Primary outcome
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Time frame: 5 MONTHS
The Wong-Baker Faces Pain Rating Scale (WB-FACES) is used to evaluate pain levels in children. This numeric rating scale ranges from 0 to 10 and is represented by faces that display emotions ranging from smiling (0 = very happy or no pain) to crying (10 = the worst pain).
Children's Fear Scale (CFS)
Time frame: 5 MONTHS
The Children's Fear Scale (CFS) is used to evaluate anxiety levels in children. It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
2 secondary outcomes
Heart Rate
Time frame: 5 MONTHS
Oxygen Saturation
Time frame: 5 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 13 Dec 2021.
- Derived from this study: PubMed 35248915Bekar P, Erkul M, Efe E. The effect of using a kaleidoscope during central venous catheter dressing changes on pain and anxiety in children with cancer: A randomised controlled trial. Eur J Oncol Nurs. 2022 Apr;57:102114. doi: 10.1016/j.ejon.2022.102114. Epub 2022 Feb 25.
- Individual participant dataSharing planned: No
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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 kaleidoscope application 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 7 inclusion and 1 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 13 Dec 2021. 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 (WB-FACES) (time frame: 5 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924023, which also lists 1 linked publication.
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 13 Dec 2021.