Clinical trial NCT06512857: The Effect of Hand Puppets and Kaleidoscope on Pain and Fear in Preschool Children
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Pain
Fear of Pain
Keywords: children
nurse
fear
pain
skin prick test
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to determine the effects of hand puppets and kaleidoscopes on some emotional parameters in preschool children who underwent skin prick testing at the pediatric allergy and immunology outpatient clinic.The study was conducted with children aged 3-6 years who underwent skin prick testing for allergy testing.In the study, the Introductory Characteristics of Children and Their Families Form, Wong-Baker Faces Pain Rating Scale (FACES) and Child Fear Scale (CFS) were used to store data.The data were uploaded to the computer and coded by the researchers, and the data were evaluated in the SPSS package program. Sociodemographic data of the children participating in the study are given as numbers and percentage distributions. The data were analyzed according to normal distribution and appropriate tests were used. The statistical significance level of the research was determined as p\<0.05. In addition, at the end of the study, with a sufficient sample size, working status was tested with post-hoc power analysis.

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.

1. In the first stage, randomization of children who met the research criteria was performed.
2. The "Introductory Characteristics Form for Children and Their Families" was filled in for the children assigned to the groups.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: WONG-BAKER FACES PAIN RATING SCALE
timeFrame: day 1
Secondary outcomes:
measure: Children's Fear Scale
timeFrame: day 1
Other outcomes:
Locations:
city: Elazig
country: Turkey
facility: Özlem Selime Merter
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.