Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety

NCT06826352 | Completed

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01/212
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Background: It is important that reduce children's pain, fear, and anxiety during the invasive procedures for building effective communication with children and their parents. Knowing the effective methods will be helpful to use in the pediatric clinical. Objective: This study aimed to determine the effects of watching cartoons, a passive distraction method and playing video games, an active distraction method, on the pain, fear and anxiety of 3- to 7-year-old children before, during and after invasive procedures. Design: A randomized controlled clinical trial Setting(s): General pediatric service of a training and research hospital in Istanbul Participants: The study sample included 105 children who were 3- to 7-years-old inpatients. The children were randomly assigned to the control (n=35), cartoon (n=35) and video game (n=35) groups. Methods: The data were collected using an introductory information form, the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale between November 26, 2019 and January 8, 2020. Data analysis was performed with SPSS software using the chi-squared test, and one-way and repeated measures ANOVA.

Conditions

Pain; Fear; Anxiety

Keywords

pain; anxiety; fear; inpatient; child; video games; cartoons; clinical trial

Outcome Measures

Primary Outcomes (1)

• The Oucher Pain Scale

  Zero is equivalent to no pain and 10 indicates the worst possible pain.

  Pain score will be decrease during the procedure within the 3 minutues.

Secondary Outcomes (1)

• The Children's State Anxiety Scale

  State Anxiety level will be decrease during the procedure within the 3 minutues.

Other Outcomes (1)

• The Children's Fear Scale

  The fear will be decrease during the procedure within the 3 minutues.

Study Arms (3)

Control Group

NO INTERVENTION

There will be no intervention, just only an intravenous procedure will be applied by the nurse.

Active Distraction

EXPERIMENTAL

The active distraction includes video games. In this group, children play video games during the procedure.

Behavioral: Active Distraction

Passive Distraction

EXPERIMENTAL

Participation will be watch cartoon.

Behavioral: Passive Distraction

Interventions

Active Distraction BEHAVIORAL

The video games will be played by children during the procedure.

Active Distraction

Passive Distraction BEHAVIORAL

The cartoons will be selected by the children related to their interests. The cartoons are included Pepee, Niloya, Tom and Jerry, Masha and The Bear and others.

Passive Distraction

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• between the ages 3-7 years
• first invasive procedures
• children do not have visual and auditory problems that prevent them from applying the scales
• developed the child's counting skills
• absence of developmental delay in language development
• absence of pain in the child before the procedure

You may not qualify if:

• second invasive procedures
• the parent didn't want to be voluntarily participate
• the child didn't want to be voluntarily participate

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul University - Cerrahpasa

Istanbul, Şişli, 34381, Turkey (Türkiye)

Location

Related Publications (5)

• Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.

  PMID: 24094126 BACKGROUND

• Gerçeker GÖ, Ayar D, Özdemir Z, Bektaş M. Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk Diline Kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 2018; 11(1), 9-13.

  BACKGROUND

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 BACKGROUND

• Beyer JE, Denyes MJ, Villarruel AM. The creation, validation, and continuing development of the Oucher: a measure of pain intensity in children. J Pediatr Nurs. 1992 Oct;7(5):335-46.

  PMID: 1479552 BACKGROUND

• Gokoglu A, Sukut O. Should I play or should I watch: the effects of active and passive distraction methods on children's pain, fear and anxiety during invasive procedures: a randomized controlled clinical trial. BMC Pediatr. 2025 Oct 28;25(1):875. doi: 10.1186/s12887-025-06188-1.

  PMID: 41152799 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Özge Sukut, PhD

  IUC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The children assessed their own conditions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: February 13, 2025
• Study Start: November 26, 2019
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)