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

StatusRecruiting
PhaseNot applicable
Started2025-05-27
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 6, 2026 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-04
Study Status, Sponsor/Collaborators v3
Re-verified, no change to tracked fields
2026-01-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-11-01→2026-05-01
Completion date2025-11-01→2026-05-01
Start dateestimated 2025-05-26→confirmed 2025-05-27
Study sitesdetails revised at 1 of 1 site
2025-05-22
Study Status, Sponsor/Collaborators, Study Description, Conditions, Outcome Measures, Eligibility, References v1
Eligibility criteria+32 characters
Inclusion Criteria: Written consent has been obtained from the parents or legal guardians. Children and adolescents agedAge 8-15 years whoold One attendof the following: Attend the Child and Youth Clinic at Haukeland University Hospital (HUS) for peripheral venous cannula insertion Attend OR who attendthe Helsebanken in Øystese for blood sampling OR who attend Attend TKVestland for planned dental treatment involving local anesthesia administered via injection (needle)OR admitted Admitted to the Child and Youth Clinic at Haukeland University Hospital for the first time due to type 1 diabetes me [...] [...]
Secondary endpoints1 to 2 entries
Self-reported distress Parental-reported pain and distress
Primary endpoints1 entry, revised
Self-reported pain
Study description-18 characters
[...] ken), and administration of local anesthesia via injection (TkVestlanddental clinic). Participants will be allocated using block randomization. [...] ruit 50 participants at CYC, 50 participants at TK Vestland dental clinic and 20 participants at Helsebanken General Practices.In addition, we will explore the use of Grasp in six patients admitted to hospital with a newly diagnosed [...] articipate in the randomized controlled part of the study.) Outcome Measures: The primary outcome measuresmeasure will be self-reported pain, reported on a combined visual analogue scale and numeric rating scale (0-10). The s [...] [...]
2025-05-20
Original filing
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
Trial Details
NCT Number NCT06984939
Lead Sponsor Haukeland University Hospital
Collaborators: University of Bergen
Conditions Pain
Enrollment 126 participants
Start Date 2025-05-27
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-06