The Effectiveness of Wearable Technology-Supported Gamification in Reducing Pain and Anxiety During Medical Procedures in Children: A Randomized Controlled Trial
NCT07930962, Not applicable, Enrolling by invitation, Bulent Ecevit University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Effectiveness of Wearable Technology-Supported Gamification in Reducing Pain and Anxiety During Medical Procedures in Children: A Randomized Controlled Trial | ClinicalTrials.gov |
| NCT number | NCT07930962 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Bulent Ecevit University | ClinicalTrials.gov |
| Conditions | Procedural Pain, Procedural Anxiety | ClinicalTrials.gov |
| Interventions | Wearable Technology-Supported Gamification | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pain Intensity Measured by the Wong-Baker FACES Pain Rating Scale | Before and immediately after the medical procedure. | 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. | ClinicalTrials.gov |
| Primary | Anxiety Level Measured by the Modified Yale Preoperative Anxiety Scale (mYPAS) | Before, during, and immediately after the medical procedure. | 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. | ClinicalTrials.gov |
| Secondary | Heart Rate and Respiratory Rate | Before, during, and immediately after the medical procedure. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
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Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
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Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.