The Effects of Playing Digital Games on Children's Pain, Fear and Anxiety Levels During Suturing

NCT05546463 | Completed

• 1 other identifier: IzmirUEcon
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim was to determine the effects of digital game play on children's pain, fear and anxiety levels during suturing. Data was obtained from 84 children between the ages of 8-17 at the Pediatric Emergency Department between 16 January and 19 March 2020, using the Socio-Demographic and Clinical Characteristics Form, the Wong-Baker Faces Pain Rating Scale (WBFPS), the Visual Analogue Scale (VAS), the Fear of Medical Procedure Scale (FMPS), and the State-Trait Anxiety Inventory for Children (STAI-CH). While the study group (n=42) played digital games during the suturing procedure, the control group (n=42) did not play digital games.

Conditions

Pain, Procedural; Fear of Needles; Anxiety State

Outcome Measures

Primary Outcomes (4)

• Socio-Demographic and Clinical Characteristics

  Socio-Demographic and Clinical Characteristics Form: This form consists of a total of 23 questions eliciting information, including on age, gender, previous digital game playing status, number of suturing, and duration of suturing, created by the researchers in accordance with the literature.

  2 months

• Pain score

  Pain score was determined using "Wong-Baker Faces Pain Rating Scale" and "Visual Analogue Scale". Wong-Baker Faces Pain Rating Scale: The Faces Pain Rating Scale, developed by Wong and Baker, is a hand-drawn scale that includes six facial expressions ranging from smiling to crying, and is recommended for use for children aged 3 years and older. Scoring is defined as 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. Visual Analogue Scale: This is a 100 mm long horizontal line with the words "no pain" and "severe pain" at either end. It is suitable for school-age children. The child is asked to mark the point showing the intensity of pain felt at that moment.

  2 months

• Anxiety score

  Anxiety score was determined using "State-Trait Anxiety Inventory for Children" State-Trait Anxiety Inventory for Children: State-Trait Anxiety Inventory for Children was developed by Spielberger in 1973 to measure the anxiety caused to children in particular situations perceived as a threat. In the trait anxiety scale, the children are asked to evaluate how they "generally" feel, and in the state anxiety scale, how they feel in the situation they are in "at that moment", and indicate one of three options. Possible scores range between 20 and 60. A higher score indicates greater anxiety. The validity and reliability study in Türkiye was conducted by Özusta in 1995 for children aged 9-12. In State-Trait Anxiety Inventory for Children, the Cronbach Alpha coefficient of the state anxiety scale was found .82, and the Cronbach Alpha coefficient of the trait anxiety scale was .81.

  2 months

• Fear score

  Fear score was determined using "Fear for Medical Procedures Scale". Fear of Medical Procedures Scale: Fear of Medical Procedures Scale was developed by Bloom et al. in 1985 to assess children's fears associated with medical procedures and practices. The scale consists of 29 questions evaluating the fear of medical procedures. The scale consists of 4 sub-dimensions, including operational, personal, environmental, and interpersonal items. In the three-point Likert-type scale, for each question, children are asked to choose one of the expressions "no fear" (1 point), "moderate fear" (2 points), "high fear" (3 points). Scores range between 29 and 87. The validity and reliability study in Türkiye was conducted among children aged 7-14 by Alak in 1993, and the reliability coefficient was found to be .93.

  2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

During the suture procedure, the children in the intervention group played digital games. Children began playing digital games about one minute before the local anesthesia procedure, continued to play digital games throughout the suturing procedure.

Behavioral: Digital games

Control group

EXPERIMENTAL

During the suture procedure, the children in the control group did not play digital games.

Behavioral: Digital games

Interventions

Digital games BEHAVIORAL

A digital game was played via iPad Air 2 32GB 9.7-inch wi-fi model tablet. The researcher created a folder with a range of selected games to appeal to different preferences. Children could choose from the following games: Word Travel, Talking Tom Candy Run, 384 Puzzles for Kids, Masha and The Bear, Subway Surfers, Head Ball 2 and Dream League Soccer".

Control group; Intervention group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having no psychological diagnoses.
• Having no problems in vision, hearing, or speech.
• Speaking and understanding Turkish.
• That the number of sutures is 3 or more.
• That the suture procedure is performing under local anesthesia.
• That they assent to participate in the study.

You may not qualify if:

• Refusing to play digital games or stop playing before the process ends.
• Having a physical problem that prevents playing digital games.
• Being too agitated to communicate with the child.

Sponsors & Collaborators

• Izmir University of Economics: lead

Study Sites (1)

Health Sciences University Izmir Tepecik Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Iatrophobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Filiz Ogce, Prof

  Izmir University of Economics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 19, 2022
• Study Start: January 16, 2020
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

TU (1)