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CompletedNCT07909798HealingUpdated Nov 2, 2026

Healing Through Play

An interventional study of Usual Care in Anxiety Wounds and Injuries, sponsored by Al-Zaytoonah University of Jordan. Completed at 1 site in Jordan. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Al-Zaytoonah University of Jordan · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

Wound dressing is a common procedure for children with injuries or wounds. The procedure can cause pain, fear, and anxiety. Children may also experience changes in heart rate and breathing when they feel distressed. Finding simple ways to help children cope with wound dressing may improve their experience of care.

This study examined changes in pain, anxiety, and physiological responses associated with playing interactive digital games during wound dressing. The study included 60 children aged 6-12 years who received wound dressing at the surgical department of Souad Kafafi University Hospital in 6th of October City, Egypt.

Each child selected an age-appropriate smartphone game and began playing approximately 1-2 minutes before wound dressing. The child continued playing throughout the procedure. Pain and anxiety were assessed, and physiological measurements, including pulse rate, breathing rate, and oxygen saturation, were recorded. The time required to complete wound dressing was also documented.

Measurements taken before and after the intervention were compared to examine changes associated with the use of digital games. The study aimed to determine whether interactive games could be a practical, child-friendly distraction to help children cope with pain and anxiety during wound dressing.

The findings may help nurses and other healthcare professionals consider the role of interactive digital games in pediatric wound care. Because the study used a single-group design without a separate control group, changes observed after the intervention cannot be attributed to the games alone.

Read the detailed description

Wound dressing is an essential component of wound management in pediatric healthcare. However, dressing changes may cause procedural pain, anxiety, fear, and physiological responses associated with distress. These experiences can make the procedure more difficult for children and may affect their willingness to cooperate with healthcare professionals.

Non-pharmacological distraction is one approach used to support children during painful or uncomfortable procedures. Interactive digital games may redirect attention away from the procedure by engaging children in age-appropriate activities. Smartphone games are readily accessible and may offer a practical distraction strategy in clinical settings.

This study investigated changes in children's pain, anxiety, physiological responses, and wound-dressing duration associated with the use of interactive digital games during wound dressing.

Study Design and Setting

A one-group pretest-posttest quasi-experimental study was conducted at the surgical department of Souad Kafafi University Hospital, 6th of October City, Egypt, from February to July 2026. A purposive sample of 60 children aged 6-12 years undergoing wound dressing participated in the study.

All participants received the digital-game intervention. Measurements obtained before the intervention were compared with those obtained after the intervention. The study did not include a separate control group.

Intervention Procedures

Each child selected an age-appropriate smartphone game according to their preference. The game was started approximately 1-2 minutes before the wound-dressing procedure and continued throughout dressing.

The intervention was intended to provide an engaging distraction during wound care. It was used as a supportive, non-pharmacological approach and was not intended to replace necessary wound care, prescribed pain management, or other clinically indicated treatment.

Assessment Procedures

Pain, anxiety, physiological responses, and procedure duration were assessed before and after the intervention according to the study protocol.

Pain was assessed using the Wong-Baker FACES Pain Rating Scale. Anxiety was measured using an adapted 20-item scale based on the Beck Anxiety Inventory. Physiological measurements included pulse rate, respiratory rate, and peripheral oxygen saturation. The time required to complete wound dressing was also recorded.

The assessment tools and procedures were used to examine changes in children's reported pain and anxiety and their physiological responses during the wound-dressing experience.

Data Analysis

Pre-intervention and post-intervention measurements were compared using paired statistical analyses, as appropriate for the data. Statistical significance was assessed using the prespecified significance threshold of p \< 0.05.

Interpretation and Potential Significance

The study provides information about the feasibility and potential value of incorporating interactive digital games into pediatric wound care. Changes observed in pain, anxiety, physiological measurements, and dressing duration may help inform future research and nursing practice.

The single-group pretest-posttest design limits the ability to establish a causal relationship between game use and observed changes. Other factors, including the nature of the wound, the dressing procedure, usual pain management, children's individual characteristics, and familiarity with the clinical environment, may have influenced the findings Further research using a suitable comparison grou

02

Conditions studied

  • Anxiety Wounds and Injuries

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Keywords

  • Digital game Anxiety Pediatric wound care Children Procedural anxiety Wound dressing Digital therapeutic intervention
03

In context

Wounds and Injuries

2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Al-Zaytoonah University of Jordan is the lead sponsor of 31 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 6-12 years.
  • Children undergoing wound dressing at the surgical department of Souad Kafafi University Hospital, 6th of October City, Egypt.
  • Children whose wound-dressing procedure allowed the use of an interactive smartphone game during the procedure.
  • Children able to understand and respond to the study's pain and anxiety assessment tools, with assistance appropriate to their age when needed.
  • Parent or legal guardian willing to provide , with child assent obtained when appropriate and required by the approved protocol.

Exclusion criteria

Exclusion Criteria

  • Children with conditions that prevented them from safely or comfortably using a smartphone during wound dressing.
  • Children with cognitive, developmental, or communication difficulties that prevented reliable completion of the study assessments.
  • Children who were clinically unstable or required emergency treatment that took priority over study procedures.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

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

Study arms

  • Experimental
    Interactive Digital Game During Wound Dressing

    Children aged 6-12 years undergoing wound dressing received an interactive digital-game intervention. Each child selected an age-appropriate smartphone game and began playing approximately 1-2 minutes before wound dressing, continuing throughout the procedure. Pain, anxiety, pulse rate, respiratory rate, oxygen saturation, and wound-dressing duration were assessed according to the study protocol. Pre-intervention and post-intervention measurements were compared. All participants received the intervention; there was no separate control group.

    Behavioral: Usual Care

  • Experimental
    Usual Care Control Group

    Children aged 6-12 years undergoing wound dressing received usual wound care without the interactive digital-game intervention. Pain, anxiety, physiological responses, and wound-dressing duration were assessed according to the study protocol.

    Behavioral: Usual Care

Interventions

  • BehavioralUsual Care

    Participants in the usual care control arm received the routine wound care provided by the clinical team according to the institution's standard practice. No study-specific digital game intervention was administered to this arm.

06

What researchers measure

Primary outcomes

  1. Change in Anxiety Level Among Children Undergoing Wound Care

    Anxiety levels were assessed using the study-specified anxiety assessment instrument. Anxiety scores were compared between the digital game intervention group and the usual care control group to evaluate the effect of the intervention on anxiety associated with pediatric wound care.

    Time frame: Immediately before and immediately after the wound-care procedure.

Secondary outcomes

  1. Child's Behavioral Response During Wound Care

    The child's behavioral response during the wound-care procedure was assessed using the study-specified behavioral assessment method. Results were compared between the intervention and control groups.

    Time frame: During the wound-care procedure

07

Study locations

1 site
  • Al zaytoonah University
    Amman, 00000, Jordan
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07909798
Lead sponsor
Al-Zaytoonah University of Jordan
Responsible party
Eman Abdelfatah Shokr (Dr, Al-Zaytoonah University of Jordan) — Principal investigator
First posted
Nov 2, 2026
Start date
Apr 4, 2026
Primary completion
May 5, 2026
Completion
Jun 7, 2026
Last update
Nov 2, 2026

Oversight

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

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