CClinicalTrials.gg
CompletedNCT06512857Updated Jul 22, 2024

The Effect of Hand Puppets and Kaleidoscope on Pain and Fear in Preschool Children

An interventional study of Hand puppet method and Kaleidoscope method in Nursing Caries, Pain and Fear of Pain, sponsored by Firat University. Completed at 1 site in Turkey. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Firat University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Nursing Caries
  • Pain
  • Fear of Pain

Keywords

  • children
  • nurse
  • fear
  • pain
  • skin prick test
03

In context

Lead sponsor

Firat University is the lead sponsor of 112 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    experimental group

    Hand puppet was used in the skin prick test process from the children in the experimental group.

    Other: Hand puppet method

  • Active comparator
    Active comprator

    Kaleidoscope was used in the skin prick test process from the children in the experimental group.

    Other: Kaleidoscope method

  • No intervention
    control group

    Routine application of the unit will be made

Interventions

  • OtherHand puppet method

    Children in the experimental group were shown a hand puppet to distract them during the skin test for allergy.

  • OtherKaleidoscope method

    Children in the other experimental group were look at kaleidoscope to distract them during the skin test for allergy.

06

What researchers measure

Primary outcomes

  1. WONG-BAKER FACES PAIN RATING SCALE

    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.

    Time frame: day 1

Secondary outcomes

  1. Children's Fear Scale

    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".

    Time frame: day 1

07

Study locations

1 site
  • Özlem Selime Merter
    Elazig, 23119, Turkey
08

References and documents

Publications

  • 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. PubMed 19583650 ↗
  • 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 ↗
  • 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. PubMed 32354466 ↗
  • 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. PubMed 32703758 ↗
  • 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. PubMed 37330277 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06512857
Lead sponsor
Firat University
Responsible party
Özlem Selime MERTER (ASSISTANT PROFESSOR, Firat University) — Principal investigator
First posted
Jul 22, 2024
Start date
May 10, 2024
Primary completion
Jul 5, 2024
Completion
Jul 5, 2024
Last update
Jul 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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