Anxiety Wounds and InjuriesHealingNCT07909798
Healing Through Play
A study of Anxiety Wounds and Injuries, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Wounds and Injuries
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJordan
- Study dates
- 4 Apr 2026to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 informed consent, with child assent obtained when appropriate and required by the approved protocol.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healing Through Play: Changes in Pain, Anxiety, and Physiological Responses Associated With Interactive Digital Games Among Children Undergoing Wound Dressing
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.
Read more
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
- Conditions
- Anxiety Wounds and Injuries
- Being tested
- Usual Care
- Keywords
- Digital game Anxiety Pediatric wound care Children Procedural anxiety Wound dressing Digital therapeutic intervention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Digital Game During Wound Dressing | Experimental | 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. Receives: Behavioral: Usual Care |
| Usual Care Control Group | Experimental | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the wound-care procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start4 Apr 2026
- Primary completion5 May 2026
- Study completion7 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-arm, one-group pretest-posttest quasi-experimental study. All participants received an interactive digital-game intervention during wound dressing. Outcomes measured before and after the intervention were compared to examine changes in pain, anxiety, physiological responses, and wound-dressing duration. There was no separate control group, and participants were not randomized.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdelfatah Shokr, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909798
- Sponsor's protocol ID
- 58-1-2026
- Acronym
- Healing
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Through Play: Changes in Pain, Anxiety, and Physiological Responses Associated With Interactive Digital Games Among Children Undergoing Wound Dressing
- ClinicalTrials.gov ID
- NCT07909798
- Acronym / sponsor ID
- Healing / 58-1-2026
- Conditions
- Anxiety Wounds and Injuries
- Keywords
- Digital game Anxiety Pediatric wound care Children Procedural anxiety Wound dressing Digital therapeutic intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 7 Jun 2026 (actual)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-arm, one-group pretest-posttest quasi-experimental study. All participants received an interactive digital-game intervention during wound dressing. Outcomes measured before and after the intervention were compared to examine changes in pain, anxiety, physiological responses, and wound-dressing duration. There was no separate control group, and participants were not randomized.
| Arm | Type | Receives |
|---|---|---|
| Interactive Digital Game During Wound Dressing | Experimental | Behavioral: Usual CareChildren 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. |
| Usual Care Control Group | Experimental | Behavioral: Usual CareChildren 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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 informed consent, with child assent obtained when appropriate and required by the approved protocol.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareParticipants 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. | Behavioural | Interactive Digital Game During Wound Dressing, Usual Care Control Group |
Primary outcome
Change in Anxiety Level Among Children Undergoing Wound Care
Time frame: Immediately before and immediately after the wound-care procedure.
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.
1 secondary outcome
Child's Behavioral Response During Wound Care
Time frame: During the wound-care procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Anxiety Wounds and Injuries, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Level Among Children Undergoing Wound Care (time frame: Immediately before and immediately after the wound-care procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.