Wound CareNCT07549191
Child's Interaction With a Social Robot During Dressing
A study testing Social Robot in people with Wound Care and Children Pain Management, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled trial, consisting of 30 experimental and 30 control groups, was to examine the effect of a child's interaction with a social robot during wound dressing on their fear and pain. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Care, Children Pain Management, Distraction Methods
- What is being tested?
- Social Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Apr 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The children should be between 5 and 10 years old.
- The child must have come to the emergency room for initial wound dressing.
- The child and parent must be able to speak and understand Turkish.
- The children must not have received any analgesics in the last four hours.
Who cannot join
- The child does not apply for their first dressing change,
- The child is not between 5-10 years old,
- The child has a mental, visual, or hearing impairment,
- The child has received any analgesic within the last four hours,
- An analgesic-containing ointment has been applied before the dressing change.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çorum Osmancık Esentepe neighbourhood destan street no 8
Çorum, Osmancık, 19500
About this study
Official title: The Effect of a Child's Interaction With a Social Robot During Dressing on Fear and Pain
The aim of this randomized controlled trial, consisting of 30 experimental and 30 control groups, was to examine the effect of a child's interaction with a social robot during wound dressing on their fear and pain.
- Conditions
- Wound Care, Children Pain Management, Distraction Methods, Distraction, Fear Anxiety, Fear
- Being tested
- Social Robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social RobotDevice
In the intervention group, the child interacts with the social robot through wound dressing, and fear and pain scales are completed by the child, parent, and researcher before and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Not robot | No intervention | The control group consists of 30 child patients aged 5-10 years. |
| Robot | Experimental | The intervention group consists of 30 child patients aged 5-10 years. Receives: Device: Social Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Fear during wound care
In the intervention group, the child interacts with the social robot during wound dressing, and fear scales are completed by the child, parent, and researcher before and after the procedure.
''The Child Fear Scale'' is designed for children aged 5-10 years. This scale uses a 0-4 rating system, representing five different facial expressions ranging from a blank expression (0=no anxiety) to a frightened face (4=severe anxiety). 0 indicates no anxiety, 1 mild anxiety, 2 moderate anxiety, 3 anxiety, and 4 severe anxiety.
Measured: 3 months
Children's Pain during wound care
In the intervention group, the child interacts with a social robot during wound dressing, and pain scales are completed by the child, parent, and researcher before and after the procedure.
''The WongBaker Facial Pain Scale'' is used for children aged 3 to 18 years. It consists of six different facial expressions, starting with a smiling face and ending with a crying face. The pain level corresponding to the faces on the scale is explained to the child: "Face 0" indicates no pain and is very happy. "Face 2" has some pain. "Face 4" has some more pain. "Face 6" has more pain. "Face 8" has very much pain. "Face 10" has unbearable pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihan KAZEL, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549191
- Sponsor's protocol ID
- OMU-KAEK-2025-188
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Child's Interaction With a Social Robot During Dressing on Fear and Pain
- ClinicalTrials.gov ID
- NCT07549191
- Acronym / sponsor ID
- OMU-KAEK-2025-188
- Conditions
- Wound Care, Children Pain Management, Distraction Methods, Distraction, Fear Anxiety, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 24 Apr 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.
The aim of this randomized controlled trial, consisting of 30 experimental and 30 control groups, was to examine the effect of a child's interaction with a social robot during wound dressing on their fear and pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not robot | No intervention | –The control group consists of 30 child patients aged 5-10 years. |
| Robot | Experimental | Device: Social RobotThe intervention group consists of 30 child patients aged 5-10 years. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The children should be between 5 and 10 years old.
- The child must have come to the emergency room for initial wound dressing.
- The child and parent must be able to speak and understand Turkish.
- The children must not have received any analgesics in the last four hours.
Key exclusion criteria (5 listed)
- The child does not apply for their first dressing change,
- The child is not between 5-10 years old,
- The child has a mental, visual, or hearing impairment,
- The child has received any analgesic within the last four hours,
- An analgesic-containing ointment has been applied before the dressing change.
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 |
|---|---|---|
| Social RobotIn the intervention group, the child interacts with the social robot through wound dressing, and fear and pain scales are completed by the child, parent, and researcher before and after the procedure. | Device | Robot |
Primary outcome
Children's Fear during wound care
Time frame: 3 months
In the intervention group, the child interacts with the social robot during wound dressing, and fear scales are completed by the child, parent, and researcher before and after the procedure. ''The Child Fear Scale'' is designed for children aged 5-10 years. This scale uses a 0-4 rating system, representing five different facial expressions ranging from a blank expression (0=no anxiety) to a frightened face (4=severe anxiety). 0 indicates no anxiety, 1 mild anxiety, 2 moderate anxiety, 3 anxiety, and 4 severe anxiety.
Children's Pain during wound care
Time frame: 3 months
In the intervention group, the child interacts with a social robot during wound dressing, and pain scales are completed by the child, parent, and researcher before and after the procedure. ''The WongBaker Facial Pain Scale'' is used for children aged 3 to 18 years. It consists of six different facial expressions, starting with a smiling face and ending with a crying face. The pain level corresponding to the faces on the scale is explained to the child: "Face 0" indicates no pain and is very happy. "Face 2" has some pain. "Face 4" has some more pain. "Face 6" has more pain. "Face 8" has very much pain. "Face 10" has unbearable pain.
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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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 testing Social Robot in people with Wound Care and Children Pain Management, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 24 Apr 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 Turkey (Türkiye). 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?
Children's Fear during wound care (time frame: 3 months). The study lists 2 primary outcomes in all. 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 24 Apr 2026.