An interventional study of Wearable Technology-Supported Gamification in Procedural Pain and Procedural Anxiety, sponsored by Bulent Ecevit University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Bulent Ecevit University · Not applicable, Interventional, and Supportive care
Among 79 studies in Pain, Procedural with a site in Turkey — 14 open to participants now, 14 under way, none of them phase 3. Pain, Procedural · Turkey.
Among the 79 studies in Pain, Procedural with a site in Turkey, this one is the 69th largest by planned enrollment of the 77 interventional ones that give a count, is one of 19 that started in 2026, is one of 75 with no phase, reaches primary completion later than 7 of the 13 other live ones, and was the 76th registered.
241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.
Browse Pain, Procedural studies →14 of the 79 studies in Pain, Procedural with a site in Turkey are open now. Recruiting first, the newest first:
TC Erciyes University · Sites in Turkey
Ages 18+ · Women only
Akdeniz University · Sites in Turkey
Ages 6–12 · Healthy volunteers
Mersin University · Sites in Turkey
Ages 4–7
Marmara University · Sites in Turkey
Ages 2 days–7 days · Healthy volunteers
Baskent University · Sites in Turkey
Ages 1 days–28 days · Healthy volunteers
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 29 Pain, Procedural studies recruiting now, 13 (45%) set no upper age limit and 14 (48%) stop at 75 or younger; 14 take children under 18; 5 take healthy volunteers.
This study: 6 Years to 12 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 19 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 90 across 227 interventional studies indexed under Pain, Procedural.
Median enrollment 100 across the 77 interventional studies, 140 across the 2 observational. Of the 63 that completed or were terminated, 2 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 79 has an industry lead sponsor. The 10 most frequent:
Bulent Ecevit University is the lead sponsor of 48 studies on the registry; 3 are open to participants now.
Bulent Ecevit University has 1 study filed under Pain, Procedural — fewer than ten, so there is no comparison to draw.
7 of the studies in Pain, Procedural with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07916064Ankara Etlik City HospitalEffect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia | 2026-12-15 |
| NCT07930962Bulent Ecevit UniversityThe Effectiveness of Wearable Technology-Supported Gamification in Reducing Pain and Anxiety During Medical Procedures in Children: A Randomized Controlled Trial | 2026-12-30 |
| NCT07761689Marmara UniversityThe Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy | 2026-12-30 |
| NCT07906834Samsun UniversityEffect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children | 2027-02 |
| NCT07907679Tarsus UniversityVirtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss | 2027-04-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 79 studies in Pain, Procedural with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized controlled trial aims to evaluate the effectiveness of wearable technology-supported gamification in reducing pain and anxiety and its effects on heart rate in children aged 6-12 years undergoing venous blood sampling or peripheral intravenous catheterization.
Medical procedures may cause pain, fear, and anxiety in children and can affect their cooperation during treatment. Distraction through age-appropriate digital activities may help children cope with these experiences. This study will investigate whether combining a smart wristband with an interactive digital storytelling activity is more effective than standard care in reducing pain and anxiety during medical procedures.
A total of 60 children will be included in the study, with 30 children assigned to the intervention group and 30 to the control group. Group allocation will be performed using a randomization procedure involving sealed envelopes containing group assignment cards.
Children in the intervention group will wear a smart wristband and participate in an interactive, space-themed digital storytelling activity presented on a tablet. The activity will include age-appropriate story elements and simple interactive tasks, such as touching targets or popping balloons, to redirect children's attention during the procedure. The story will guide children through different stages of the activity, from the beginning of the mission to its completion. At the end of the procedure, children will receive a positive reinforcement sticker. Children in the control group will receive standard nursing care without the gamification intervention.
Pain will be assessed using the Wong-Baker FACES Pain Rating Scale, and anxiety will be evaluated using the Modified Yale Preoperative Anxiety Scale. Heart rate will be recorded before, during, and after the procedure. The outcomes will be compared between the intervention and control groups.
The study hypothesis is that wearable technology-supported gamification will be associated with lower pain and anxiety levels and lower heart rates during invasive medical procedures compared with standard care. The study will also examine whether this approach may help improve children's cooperation during the procedures.
This randomized controlled interventional study aims to evaluate the effectiveness of wearable technology-supported gamification during invasive medical procedures in children. The intervention combines a smart wristband with an interactive, space-themed digital storytelling activity designed to redirect children's attention and support their cooperation during venous blood sampling and peripheral intravenous catheterization.
The study will include 60 children, with 30 participants planned for the intervention group and 30 for the control group. Participants will be allocated to the groups using a randomization procedure involving sealed envelopes containing group assignment cards.
Intervention Group
The intervention will be implemented in three stages: before, during, and after the medical procedure.
Before the procedure, the researcher will meet with the child and parent or legal guardian, explain the study, and obtain the required consent and assent. The child's anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale. A smart wristband will then be placed on the child's wrist, and baseline heart rate will be recorded.
During the procedure, the child will participate in an interactive, space-themed digital storytelling activity presented on a tablet. The activity will be designed to engage the child through a mission-based narrative and age-appropriate interactive tasks. The story will include stages such as "Welcome to the Space Station," "Put on Your Super Shield," "Collect Stardust," and "Mission Completed, Energy Recharged."
The child will be encouraged to participate as a space explorer. While the healthcare professional prepares for and performs the medical procedure, the child will be guided through simple digital activities, such as popping balloons or touching interactive targets on the tablet. The smart wristband will be incorporated into the story as part of the child's "superpower" experience. Heart rate will be monitored and recorded before, during, and after the procedure, including the highest heart rate recorded during the procedure.
After the procedure, the child's anxiety will be reassessed using the Modified Yale Preoperative Anxiety Scale, and pain will be assessed using the Wong-Baker FACES Pain Rating Scale. The child will receive a "Brave Hero" sticker as positive reinforcement at the end of the activity.
Control Group
Children assigned to the control group will receive routine clinical procedures and standard nursing care without the digital gamification activity or the wearable technology-supported intervention. Venous blood sampling and peripheral intravenous catheterization will be performed by experienced healthcare professionals according to routine clinical practice.
Data Collection and Statistical Analysis
Study data will be collected using a researcher-developed Personal Information Form, the Modified Yale Preoperative Anxiety Scale, the Wong-Baker FACES Pain Rating Scale, and heart rate measurements. The personal information form will include demographic and clinical characteristics, details of the medical procedure, previous experiences with similar procedures, the presence of a parent or accompanying person, and previous experience with wearable technology and digital games.
Data will be analyzed using IBM SPSS Statistics. The distribution of the data will be assessed using the Kolmogorov-Smirnov test. Descriptive statistics will include frequencies, percentages, means, and standard deviations, as appropriate. Between-group comparisons will be performed using the independent-samples t-test or the Mann-Whitney U test, depending on the distribution of the data. Appropriate parametric or nonparametric methods will be used to analyze repeated measurements. Statistical significance will be set at p \< 0.05.
Ethical Considerations
Written informed consent will be obtained from parents or legal guardians, and age-appropriate assent will be obtained from participating children. Participant information will be kept confidential and used only for scientific purposes. The child's physical and psychological well-being will be prioritized throughout the study. The intervention will be discontinued if the child experiences excessive pain or distress or if a clinical complication occurs. Routine medical procedures will be performed by experienced healthcare professionals.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
articipants in this group will receive standard nursing care and wearable technology-supported gamification during venous blood sampling or peripheral intravenous catheterization. The intervention will include wearing a smart wristband and participating in an interactive, space-themed digital storytelling activity presented on a tablet to redirect attention during the medical procedure.
Behavioral: Wearable Technology-Supported Gamification
Participants in this group will receive routine clinical procedures and standard nursing care during venous blood sampling or peripheral intravenous catheterization, without the wearable technology-supported gamification intervention.
The intervention combines a smart wristband with an interactive, space-themed digital storytelling and gamification activity presented on a tablet. During venous blood sampling or peripheral intravenous catheterization, children will be encouraged to participate in age-appropriate interactive tasks, such as popping balloons or touching targets, to redirect their attention from the medical procedure. The activity will follow a mission-based story with stages from the beginning to the completion of the mission. Heart rate will be recorded before, during, and after the procedure using the study's planned measurement methods.
Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale. Children will be asked to select the face that best represents their pain intensity. The scale consists of six facial expressions scored as follows: 0 (no hurt), 2 (hurts a little bit), 4 (hurts a little more), 6 (hurts even more), 8 (hurts a whole lot), and 10 (hurts worst). Higher scores indicate greater pain intensity. Pain scores will be compared between the intervention and control groups.
Time frame: Before and immediately after the medical procedure.
Anxiety Level Measured by the Modified Yale Preoperative Anxiety Scale (mYPAS)
Children's anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS). The scale consists of 22 items across five behavioral categories: activity, vocalizations, emotional expressivity, state of arousal, and use of parents. Each category is scored according to the child's observed behaviors. The category scores are standardized and combined to obtain a total score ranging from 23.33 to 100. Higher scores indicate higher levels of anxiety. Anxiety scores will be recorded before, during, and immediately after the medical procedure and compared between the intervention and control groups.
Time frame: Before, during, and immediately after the medical procedure.
Heart Rate and Respiratory Rate
Heart rate and respiratory rate will be measured before, during, and immediately after the medical procedure. In the intervention group, these physiological parameters will also be monitored using a wearable smart wristband, and the maximum values recorded during the procedure will be documented. Measurements will be compared between the intervention and control groups to evaluate physiological responses during the medical procedure.
Time frame: Before, during, and immediately after the medical procedure.
Plan to share: Yes — De-identified individual participant data underlying the results reported in the study, including demographic characteristics, pain and anxiety scores, and physiological measurements, may be shared with qualified researchers upon reasonable request after publication of the study results, subject to ethical approval and applicable data protection requirements. The study protocol and statistical analysis plan may also be shared. Participant identifying information will not be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: De-identified individual participant data and supporting documents will be available beginning 12 months after publication of the study results. Data will remain available for 5 years.
Access criteria: Qualified researchers may request access to de-identified individual participant data and supporting documents for scientifically sound research purposes. Requests will be reviewed by the principal investigator. Access will be subject to ethical approval where applicable, appropriate data protection measures, and a data-sharing agreement. Participant identifying information will not be shared.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 141 non-industry interventional studies with no phase under Pain, Procedural, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 6 months is below that.
Counting every sponsor, half of 141 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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 ↗
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Bulent Ecevit University