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

July 19, 2024 updated by: Özlem Selime MERTER, Firat University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Elazig, Turkey, 23119
        • Özlem Selime Merter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2024

Primary Completion (Actual)

July 5, 2024

Study Completion (Actual)

July 5, 2024

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024/04-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Pain

Clinical Trials on Hand puppet method

Subscribe