NCT06984939 A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
| NCT ID | NCT06984939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2025-05-27 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Written consent has been obtained from the parents or legal guardians. * Age 8-15 years old One of the following: 1. Attend the Child and Youth Clinic at Haukeland University Hospital for peripheral venous cannula insertion 2. Attend the Helsebanken in Øystese for blood sampling 3. Attend TKVestland for planned dental treatment involving local anesthesia administered via injection (needle) 4. 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 Criteria: * 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
Contact & Investigator
Mette Engan, PhD
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT06984939 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 15 Years, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06984939 currently recruiting?
Yes, NCT06984939 is actively recruiting participants. Contact the research team at mette.engan@helse-bergen.no for enrollment information.
Where is the NCT06984939 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT06984939 clinical trial?
NCT06984939 is sponsored by Haukeland University Hospital. The principal investigator is Mette Engan, PhD at Haukeland University Hospital. The trial plans to enroll 126 participants.