A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
Use of a Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
Haukeland University Hospital
126 participants
May 27, 2025
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria6
- 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
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Interventions
Participants assigned to the intervention group will be instructed to squeeze the Grasp ball at regular intervals of approximately every 1-2 seconds. This action will activate a melody played through a speaker connected to the iPad, accompanied by a dynamic wavy line displayed on the screen. Participants will begin squeezing the Grasp ball at least 10 seconds prior to the start of the procedure and will continue until the procedure is completed.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06984939