Actively Recruiting

Phase Not Applicable
Age: 8Years - 15Years
All Genders
NCT06984939

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

Age: 8Years - 15Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Haukeland University Hospital

Bergen, Vestland, Norway, 5021

Actively Recruiting

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