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

NCT06984939 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-03-06

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Grasp

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.

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Mette Engan, PhD · Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-27
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06984939 on ClinicalTrials.gov