- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06512857
The Effect of Hand Puppets and Kaleidoscope on Pain and Fear in Preschool Children
The Effect of Hand Puppets and Kaleidoscope on Pain and Fear in Preschool Children Who Had Skin Prick Tests in the Pediatric Allergy and Immunology Polyclinic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Type of Research: It is a randomized controlled type research. Place and Characteristics of the Research: It was conducted in the pediatric allergy and immunology outpatient clinic of Fırat University Hospital, with children aged 3-6 years who underwent skin testing for allergy. Children are accompanied by a companion during their examinations. In the routine, no distraction method is used for children during the procedure.
Allocation into groups was done using simple random sampling. Collection of data Study data were collected in 3 groups. Hand puppet group: The hand puppet was used to divert the attention of the children in the group during the skin prick test. The cost of the hand puppet was covered by the researcher.
Kaleidoscope group: It was used to divert the attention of the children in the kaleidoscope group during the skin prick test. Kaleidoscope, also known as a kaleidoscope, is a play tool that multiplies the outside image when viewed inside. The cost of the kaleidoscope was covered by the researcher.
Control group: No intervention was made to the children in the control group during the skin prick test.
- In the first stage, randomization of children who met the research criteria was performed.
- The "Introductory Characteristics Form for Children and Their Families" was filled in for the children assigned to the groups.
- After the children's doctor's examination at the pediatric allergy and immunology outpatient clinic, the child and his/her family, for whom a skin prick test was requested, were evaluated in the room where the test would be performed. The children in the hand puppet group were started to play games with the hand puppet by the researcher 1 minute before the procedure. During the procedure, the children in the kaleidoscope group were asked to look inside the kaleidoscope and describe the shapes they saw, thus drawing their attention to the shapes in the kaleidoscope. No application was made to the children in the control group during the skin prick test. Children, their families and the observer were asked to answer the "Wong-Baker Faces Pain Rating Scale (FACES)" and "Child Fear Scale (CFS)" questions before and after the treatment. Skin prick test was applied to all children in the sample group by the same nurse, in accordance with the procedure steps.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Elazig, Turkey, 23119
- Özlem Selime Merter
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 3-6 years.
- The child and his/her parents volunteer to participate in the research.
- No mental or neurological disability,
- Not having a life-threatening disease,
- Children's cognitive level and motor development are appropriate,
- No visual or auditory problems,
- Children who have not undergone any invasive procedure other than skin prick testing.
- Those who have not had a skin prick test before.
- The child does not complain of acute pain. (Pain scale VAS score is 0)
Exclusion Criteria:
- Children requiring intravenous or intramuscular intervention before skin prick test
- Development of complications during the procedure
- Being so agitated that it is impossible to communicate with the child.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Routine application of the unit will be made
|
|
|
Experimental: experimental group
Hand puppet was used in the skin prick test process from the children in the experimental group.
|
Children in the experimental group were shown a hand puppet to distract them during the skin test for allergy.
|
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Active Comparator: Active comprator
Kaleidoscope was used in the skin prick test process from the children in the experimental group.
|
Children in the other experimental group were look at kaleidoscope to distract them during the skin test for allergy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WONG-BAKER FACES PAIN RATING SCALE
Time Frame: day 1
|
In this scale, faces are given pain scores according to numerical values.
The lowest score is "0" and the highest score is "10".
As the score from the scale increases, the intensity of pain increases, and as the score decreases, the intensity decreases.
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Fear Scale
Time Frame: day 1
|
5 cartoon face pictures were used in the scale.
Anxiety level is evaluated with numbers between "0" and "4".
A score of "0" indicates "no anxiety" and a score of "4" indicates "severe anxiety".
|
day 1
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bulut M, Kucuk Alemdar D, Bulut A, Salci G. The Effect of Music Therapy, Hand Massage, and Kaleidoscope Usage on Postoperative Nausea and Vomiting, Pain, Fear, and Stress in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Dec;35(6):649-657. doi: 10.1016/j.jopan.2020.03.013. Epub 2020 Jul 20.
- Tufekci FG, Celebioglu A, Kucukoglu S. Turkish children loved distraction: using kaleidoscope to reduce perceived pain during venipuncture. J Clin Nurs. 2009 Aug;18(15):2180-6. doi: 10.1111/j.1365-2702.2008.02775.x.
- 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.
- Semerci R, Akgun Kostak M. The Efficacy of Distraction Cards and Kaleidoscope for Reducing Pain During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Aug;35(4):397-402. doi: 10.1016/j.jopan.2020.02.003. Epub 2020 Apr 28.
- Oluc T, Sarialioglu A. The effect of a hand puppet-based therapeutic play for preschool children on the fear and pain associated with blood collection procedure. J Pediatr Nurs. 2023 Sep-Oct;72:e80-e86. doi: 10.1016/j.pedn.2023.06.012. Epub 2023 Jun 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/04-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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