Grasp handheld squeeze device to distract children during needle procedures
Official title: Use of a Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
Run by Haukeland University Hospital · NCT06984939 · Data updated 2026-11-12
This project will try to see if squeezing the handheld Grasp device reduces pain and upset for children aged 8–15 during needle procedures like blood draws, IVs, or dental injections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 15 Years |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Status | Recruiting |
| Started | May 27, 2025 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT06984939 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 8–15 who need a blood draw, peripheral IV, or dental local anesthetic injection at the listed clinics, whose parents give written consent and who understand Norwegian are ideal candidates.
✕Probably not a fit
Children with moderate to severe intellectual disability, impaired vision or hearing, acute illness affecting their condition, those expecting sedation, or those who do not understand Norwegian are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 8–15 who are having minor needle procedures at participating Norwegian clinics will either use the Grasp handheld squeeze device or receive standard care during the procedure. Grasp is a soft silicone ball with pressure sensors that gives real-time visual and sound feedback via an iPad app when squeezed. Participants will report their pain and distress on brief paper forms before and after the procedure, and those ratings will be compared between groups. The project aims to build evidence about active distraction as a non-drug method to reduce procedural distress in pediatric settings.
Why it matters
Potential benefit: If successful, Grasp could lower reported pain and distress during routine needle procedures and improve the experience for children without using drugs.
How similar studies have gone: Active distraction approaches (for example, handheld devices, music, or virtual reality) have shown moderate success in reducing pediatric procedural pain, though the Grasp device itself is a newer, specific implementation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Haukeland University Hospital
Bergen, Vestland, Norway Recruiting
Study contacts
- Principal investigator: Mette Engan, PhD — Haukeland University Hospital
- Study coordinator: Mette Engan, PhD
- Email: mette.engan@helse-bergen.no
- Phone: 004741106563
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.