Procedural PainNCT07632625
Social Robot Interaction on Fear and Pain Levels in Children
A study testing Social Robot and Digital Game in people with Procedural Pain and Procedural Fear, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Procedural Fear
- What is being tested?
- Social Robot and Digital Game
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2025to 30 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-12 years
- Clinical indication for venous blood sampling
- Ability to communicate in Turkish
- No cognitive disabilities
- No sensory disabilities
- Parent or legal guardian provides informed consent
- Child provides verbal assent
Who cannot join
- Requirement for emergency medical intervention
- Use of analgesic medication within 6 hours prior to the procedure
- Diagnosis of developmental delay
- Previous participation in a social robot-based intervention or study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Social Robot Interaction on Fear and Pain Levels in Children During Venous Blood Sampling: A Randomized Controlled Study
The goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases.
The main questions it aims to answer are:
Read more
- Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling?
- Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling.
Participants will:
- Be randomly assigned to one of three groups: social robot, digital game, or standard care.
- Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure.
- Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups.
- Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.
- Conditions
- Procedural Pain, Procedural Fear
- Being tested
- Social Robot, Digital Game
- Keywords
- social robot, children, pain, anxiety, fear
- Medical subject headings
- Pain, Procedural, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social RobotOther
Children interacted with an interactive social robot for approximately 5 minutes before venous blood sampling and throughout the procedure. The robot provided age-appropriate storytelling, songs, verbal communication, movement-based interaction, and visual stimulation to distract children and reduce procedural fear and pain.
Digital GameOther
Children received a digital game-based distraction intervention using the Bubble Rainbow application. Participants were allowed to familiarize themselves with the game for approximately 5 minutes before venous blood sampling. During the procedure, children continued playing the game on a tablet device while receiving support from their parents. The game included interactive activities such as bubble popping, color matching, and visual attention tasks designed to engage the child's attention and reduce procedural fear and pain.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| social robot | Experimental | Not described Receives: Other: Social Robot |
| digital game | Experimental | Not described Receives: Other: Digital Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Rating Scale
Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions scored from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity
Measured: Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
Children Fear Scale
Procedural fear was assessed using the Scary Scale, a self-report instrument designed for children aged 4-12 years. The scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear), with higher scores indicating greater fear levels.
Measured: Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start21 Dec 2025
- Primary completion21 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remziye Semerci, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632625
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lakatos G, Gacsi M, Konok V, Bruder I, Bereczky B, Korondi P, Miklosi A. Emotion attribution to a non-humanoid robot in different social situations. PLoS One. 2014 Dec 31;9(12):e114207. doi: 10.1371/journal.pone.0114207. eCollection 2014.
PubMed 25551218Fox J, Gambino A. Relationship Development with Humanoid Social Robots: Applying Interpersonal Theories to Human-Robot Interaction. Cyberpsychol Behav Soc Netw. 2021 May;24(5):294-299. doi: 10.1089/cyber.2020.0181. Epub 2021 Jan 11.
PubMed 33434097
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Social Robot Interaction on Fear and Pain Levels in Children During Venous Blood Sampling: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07632625
- Acronym / sponsor ID
- 1
- Conditions
- Procedural Pain, Procedural Fear
- Keywords
- social robot, children, pain, anxiety, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 8 Jun 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 goal of this clinical trial is to compare the effectiveness of social robot interaction and digital game-based distraction in reducing fear and pain during venous blood sampling in children aged 4-12 years with chronic diseases.
The main questions it aims to answer are:
- Does social robot interaction reduce procedural fear and pain more effectively than standard care during venous blood sampling?
- Does social robot interaction provide greater emotional recovery after the procedure compared with digital game-based distraction and standard care? Researchers will compare a social robot intervention group, a digital game-based distraction group, and a standard care group to determine their effects on children's fear and pain levels before, during, and after venous blood sampling.
Participants will:
- Be randomly assigned to one of three groups: social robot, digital game, or standard care.
- Complete fear and pain assessments 5 minutes before, during, and 5 minutes after the venous blood sampling procedure.
- Interact with a social robot or play a digital game before and during the procedure if assigned to one of the intervention groups.
- Receive routine clinical care if assigned to the standard care group. The study aims to provide evidence on the effectiveness of technology-based distraction methods for reducing procedural distress and improving the procedural experience of children undergoing venous blood sampling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| social robot | Experimental | Other: Social Robot |
| digital game | Experimental | Other: Digital Game |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 4-12 years
- Clinical indication for venous blood sampling
- Ability to communicate in Turkish
- No cognitive disabilities
- No sensory disabilities
Key exclusion criteria (4 listed)
- Requirement for emergency medical intervention
- Use of analgesic medication within 6 hours prior to the procedure
- Diagnosis of developmental delay
- Previous participation in a social robot-based intervention or study
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 RobotChildren interacted with an interactive social robot for approximately 5 minutes before venous blood sampling and throughout the procedure. The robot provided age-appropriate storytelling, songs, verbal communication, movement-based interaction, and visual stimulation to distract children and reduce procedural fear and pain. | Other | social robot |
| Digital GameChildren received a digital game-based distraction intervention using the Bubble Rainbow application. Participants were allowed to familiarize themselves with the game for approximately 5 minutes before venous blood sampling. During the procedure, children continued playing the game on a tablet device while receiving support from their parents. The game included interactive activities such as bubble popping, color matching, and visual attention tasks designed to engage the child's attention and reduce procedural fear and pain. | Other | digital game |
Primary outcome
Wong-Baker Faces Pain Rating Scale
Time frame: Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions scored from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity
Children Fear Scale
Time frame: Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.
Procedural fear was assessed using the Scary Scale, a self-report instrument designed for children aged 4-12 years. The scale consists of six facial expressions scored from 0 (no fear) to 10 (highest fear), with higher scores indicating greater fear levels.
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 10 Jun 2026.
- Results publication: PubMed 25551218Lakatos G, Gacsi M, Konok V, Bruder I, Bereczky B, Korondi P, Miklosi A. Emotion attribution to a non-humanoid robot in different social situations. PLoS One. 2014 Dec 31;9(12):e114207. doi: 10.1371/journal.pone.0114207. eCollection 2014.
- Results publication: PubMed 33434097Fox J, Gambino A. Relationship Development with Humanoid Social Robots: Applying Interpersonal Theories to Human-Robot Interaction. Cyberpsychol Behav Soc Netw. 2021 May;24(5):294-299. doi: 10.1089/cyber.2020.0181. Epub 2021 Jan 11.
- 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 and Digital Game in people with Procedural Pain and Procedural Fear, run by Trakya 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 7 inclusion and 4 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 10 Jun 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?
Wong-Baker Faces Pain Rating Scale (time frame: Pain was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure.). 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?
On the ClinicalTrials.gov record for NCT07632625, which also lists 2 linked publications.
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 10 Jun 2026.