NCT06512857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 10, 2024

Last Update Submit

July 19, 2024

Conditions

Keywords

childrennursefearpainskin prick test

Outcome Measures

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.

    day 1

Secondary Outcomes (1)

  • Children's Fear Scale

    day 1

Study Arms (3)

experimental group

EXPERIMENTAL

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

Other: Hand puppet method

Active comprator

ACTIVE COMPARATOR

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

Other: Kaleidoscope method

control group

NO INTERVENTION

Routine application of the unit will be made

Interventions

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

experimental group

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

Active comprator

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özlem Selime Merter

Elâzığ, 23119, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 19583650BACKGROUND
  • 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.

    PMID: 35248915BACKGROUND
  • 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.

    PMID: 32354466BACKGROUND
  • 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.

    PMID: 32703758BACKGROUND
  • 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.

    PMID: 37330277BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSISTANT PROFESSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 22, 2024

Study Start

May 10, 2024

Primary Completion

July 5, 2024

Study Completion

July 5, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations