A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures

Recruiting now · Not applicable

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT06984939

Run by

Haukeland University Hospital

People needed

126

Starts

2025-05-27

Expected to finish

2026-05-01

Last updated by the study team

2026-03-06

Who can join

Age: 8 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written consent has been obtained from the parents or legal guardians.
• Age 8-15 years old
• One of the following:
• Attend the Child and Youth Clinic at Haukeland University Hospital for peripheral venous cannula insertion
• Attend the Helsebanken in Øystese 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 may not qualify if…

• 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

Where it is running

• Haukeland University Hospital — Bergen, Vestland, Norway (enrolling)

Full record on ClinicalTrials.gov

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