Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | ||
| social robot | Experimental |
| |
| digital game | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Robot | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Fear was assessed 5 minutes before venous blood sampling, during the procedure, and 5 minutes after the procedure. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University | Istanbul | Istanbul | 34010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25551218 | Result | 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. | |
| 33434097 | Result | Fox 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D012371 | Robotics |
| ID | Term |
|---|---|
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Digital Game | Other | 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. |
|