PainNCT06352021
The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children
A study testing kaleidoscope in people with Pain, run by İlknur KAHRİMAN at 1 site in Turkey (Türkiye).
Trial summary
This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- kaleidoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2019to 30 Jun 2019
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- were being 7-12 years of age
- not having an auditory or visual disability
- not taking analgesics in the last eight hours
- not having any pain caused by other reasons before the procedure
- having vascular access and blood sampling interventions
Who cannot join
- having physical or mental disability
- having any nerve damage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University Health Application and Research Center Farabi Hospital
Trabzon, 61080
About this study
This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.
Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling.
Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling.
Read the detailed description
A pain-free life is the right of every child. Eliminating pain and improving the quality of life of children is one of the main goals of nursing care. Pediatric nurses should choose the appropriate assessment tool for the child's age and developmental characteristics and diagnose pain correctly. For this purpose, nurses can use appropriate distraction methods. Since the nurse is the healthcare worker who is with the child and family the most throughout the day, s/he should closely monitor and evaluate the child's pain and inform the child and family about the principles of pain control. Many hospitals in Türkiye generally do not use any non-pharmacologic methods to reduce procedural pain. Given that distraction techniques are inexpensive and easy to use, and that reducing children's pain may reduce negative feelings towards future procedures, it is important to examine the effectiveness of such methods. In our study, a kaleidoscope, one of the methods of distraction to reduce pain during blood sampling in children, was used. A kaleidoscope is a game tool that helps distract the child's attention from procedural pain and shows the external image by reproducing it when viewed through it. This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.
- Conditions
- Pain
- Being tested
- kaleidoscope
- Keywords
- Blood collection, Distraction, Non-pharmacological treatment, Pain, Schoolchild
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kaleidoscopeDevice
The children in the kaleidoscope group were shown the kaleidoscope by the researcher five minutes before the blood sampling, and they were encouraged to look at the kaleidoscope during the procedure and describe the patterns they saw. All children in the Kaleidoscope group agreed to participate in the study. All children in the kaleidoscope group were asked to look at the kaleidoscope just before the tourniquet was placed on their arms before the blood sampling procedure and to describe the patterns, they saw in it by turning it slowly during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| kaleidoscope group | Experimental | The children in the kaleidoscope group were shown the kaleidoscope by the researcher five minutes before the blood sampling, and they were encouraged to look at the kaleidoscope during the procedure and describe the patterns they saw. Receives: Device: kaleidoscope |
| control group | No intervention | This group underwent routine blood sampling procedures and did not receive any intervention to reduce their pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Wong-Baker Pain Scale
The scale was developed by Wong and Baker (1981) to assess pain between the ages of 3-18 years. It has been reported in the literature that it accurately measures children's pain. The scale has numerical values according to each facial expression. The lowest and the highest values are 0 and 5. As the score on the scale increases, sensitivity to pain decreases, and as the score decreases, sensitivity increases.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start30 May 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- İlknur KAHRİMAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İlknur KAHRİMAN, Karadeniz Technical University
- Investigators
- Ilknur Kahriman, Assoc. Prof., Study director, Karadeniz Technical UniversityBeyhan Turkan, Master, Principal investigator, TRABZON KANUNI EDUCATION RESEARCH HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352021
- Sponsor's protocol ID
- KAHRİMAN İlknur
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children
- ClinicalTrials.gov ID
- NCT06352021
- Acronym / sponsor ID
- KAHRİMAN İlknur
- Conditions
- Pain
- Keywords
- Blood collection, Distraction, Non-pharmacological treatment, Pain, Schoolchild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- İlknur KAHRİMANUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 8 Apr 2024 (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.
This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.
Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling.
Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling.
Detailed description
A pain-free life is the right of every child. Eliminating pain and improving the quality of life of children is one of the main goals of nursing care. Pediatric nurses should choose the appropriate assessment tool for the child's age and developmental characteristics and diagnose pain correctly. For this purpose, nurses can use appropriate distraction methods. Since the nurse is the healthcare worker who is with the child and family the most throughout the day, s/he should closely monitor and evaluate the child's pain and inform the child and family about the principles of pain control. Many hospitals in Türkiye generally do not use any non-pharmacologic methods to reduce procedural pain. Given that distraction techniques are inexpensive and easy to use, and that reducing children's pain may reduce negative feelings towards future procedures, it is important to examine the effectiveness of such methods. In our study, a kaleidoscope, one of the methods of distraction to reduce pain during blood sampling in children, was used. A kaleidoscope is a game tool that helps distract the child's attention from procedural pain and shows the external image by reproducing it when viewed through it. This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kaleidoscope group | Experimental | Device: kaleidoscopeThe children in the kaleidoscope group were shown the kaleidoscope by the researcher five minutes before the blood sampling, and they were encouraged to look at the kaleidoscope during the procedure and describe the patterns they saw. |
| control group | No intervention | –This group underwent routine blood sampling procedures and did not receive any intervention to reduce their pain. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- were being 7-12 years of age
- not having an auditory or visual disability
- not taking analgesics in the last eight hours
- not having any pain caused by other reasons before the procedure
- having vascular access and blood sampling interventions
Key exclusion criteria (2 listed)
- having physical or mental disability
- having any nerve damage
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 |
|---|---|---|
| kaleidoscopeThe children in the kaleidoscope group were shown the kaleidoscope by the researcher five minutes before the blood sampling, and they were encouraged to look at the kaleidoscope during the procedure and describe the patterns they saw. All children in the Kaleidoscope group agreed to participate in the study. All children in the kaleidoscope group were asked to look at the kaleidoscope just before the tourniquet was placed on their arms before the blood sampling procedure and to describe the patterns, they saw in it by turning it slowly during the procedure. | Device | kaleidoscope group |
Primary outcome
The Wong-Baker Pain Scale
Time frame: 5 minutes
The scale was developed by Wong and Baker (1981) to assess pain between the ages of 3-18 years. It has been reported in the literature that it accurately measures children's pain. The scale has numerical values according to each facial expression. The lowest and the highest values are 0 and 5. As the score on the scale increases, sensitivity to pain decreases, and as the score decreases, sensitivity increases.
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 8 Apr 2024.
- 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.
Ilknur Kahriman, Assoc. Prof. study director
Karadeniz Technical University
Beyhan Turkan, Master principal investigator
TRABZON KANUNI EDUCATION RESEARCH HOSPITAL
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 in people with Pain, run by İlknur KAHRİMAN 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 5 inclusion and 2 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 8 Apr 2024. 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?
The Wong-Baker Pain Scale (time frame: 5 minutes). 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 8 Apr 2024.