Procedural Fear, Procedural Pain
Conditions
Keywords
social robot, children, pain, anxiety, fear
Brief 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. 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.
Interventions
OTHERSocial Robot
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.
OTHERDigital Game
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.
Sponsors
Trakya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker Faces Pain Rating Scale | 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 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed