Grasp handheld squeeze device to distract children during needle procedures
Use of a Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 8 Years to 15 Years |
| Sex | All |
| Sponsor | Haukeland University Hospital Academic / other |
| Locations | 1 site (Bergen, Vestland) |
| Trial ID | NCT06984939 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bergen, Vestland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.