Actively Recruiting
A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
Led by Haukeland University Hospital · Updated on 2026-03-06
126
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
U
University of Bergen
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the handheld device Grasp, works to reduce pain and distress during small procedures involving a needle prick in children and adolescents. The main question it aims to answer is: Does repetitive squeezing of the Grasp device during the painful procedure affect self-reported pain and distress? Researchers will compare using the Grasp device during procedures where children and adolescent are having a needle prick (venous puncture, insertion of a peripheral venous catheter, local anesthetic injection before dental treatment) with standard care, to see if Grasp works to reduce pain and distress. Participants will: * Use Grasp or standard care during procedures involving a needle prick * Report pain and distress on a paper form before and after the procedure
CONDITIONS
Official Title
A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent has been obtained from the parents or legal guardians.
- Age 8-15 years old
- Attend the Child and Youth Clinic at Haukeland University Hospital for peripheral venous cannula insertion
- Attend the Helsebanken in �d8ystese for blood sampling
- Attend TKVestland for planned dental treatment involving local anesthesia administered via injection (needle)
- Admitted to the Child and Youth Clinic at Haukeland University Hospital for the first time due to type 1 diabetes mellitus, requiring frequent blood glucose measurements and insulin injections.
You will not qualify if you...
- Moderate to severe intellectual disability
- Impaired vision or hearing
- Does not understand the Norwegian language
- General condition affected by illness
- Anticipated use of sedation during the procedure (e.g., Midazolam)
- Previous participation in this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
Actively Recruiting
Research Team
M
Mette Engan, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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