The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial.
Gamze Inan, Sevil Inal
https://pubmed.ncbi.nlm.nih.gov/30362982Actively Recruiting
Phase Not Applicable
Age: 8Years - 15Years
All Genders
ID06984939
Use of a Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
Led by Haukeland University Hospital · Updated on 2026-03-06
126
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Haukeland University Hospital
Lead Sponsor
U
University of Bergen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether the handheld device called Grasp can help reduce pain and distress in children and adolescents aged 8 to 15 during small needle procedures. These procedures include venous puncture, insertion of a peripheral venous catheter, and local anesthesia injections before dental treatment. The study aims to compare the effects of using Grasp during these procedures with standard care to see if it helps improve the experience for young patients. Grasp is a soft silicone ball with pressure sensors that detect squeezes of different strengths and durations. When squeezed, it provides real-time visual and auditory feedback through an iPad application, playing melodies and showing dynamic curves. Participants in the intervention group will squeeze the Grasp ball repeatedly, starting at least 10 seconds before and continuing throughout the needle procedure. The control group will receive standard care without Grasp. In addition to the randomized trial, six children with type 1 diabetes will use Grasp during blood sugar measurements or insulin injections as part of exploratory use. During the study, participants will fill out questionnaires about their pain and distress before and after the procedure, as will their parents or guardians. Some participants at the dental clinic will use Grasp during further dental treatment and complete additional forms afterward. The main measure is self-reported pain immediately after the procedure, with secondary measures including distress reported by both children and parents. The study includes interviews with some participants to explore their experiences, and statistical analyses will assess the impact of using Grasp.
CONDITIONS
Brief Title
A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
Who Can Participate
Age: 8Years - 15Years
All Genders
Eligibility Criteria
You may qualify if you...
- Written consent obtained from parents or legal guardians
- Age between 8 and 15 years old
- Attending Child and Youth Clinic at Haukeland University Hospital for peripheral venous cannula insertion
- Attending Helsebanken in �d8ystese for blood sampling
- Attending TKVestland for planned dental treatment with local anesthesia injection
- Admitted to Child and Youth Clinic at Haukeland University Hospital for first-time type 1 diabetes mellitus treatment involving blood glucose measurements and insulin injections
You will not qualify if you...
- Moderate to severe intellectual disability
- Impaired vision or hearing
- Does not understand the Norwegian language
- General condition affected by illness
- Expected use of sedation during the procedure (e.g., Midazolam)
- Previous participation in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of the individual procedure visit
Participants undergo a minor medical procedure such as peripheral venous cannulation, blood sampling, or local anesthesia injection. Those in the Grasp group will use the handheld Grasp device by squeezing the ball repeatedly before and during the procedure to provide active distraction.
1 procedure visit (in-person)
Follow-up
Duration - Immediately after procedure up to completion of dental treatment
Immediately after the procedure, participants and their parents or guardians complete questionnaires regarding pain, distress, and their experience. Participants at the dental clinic may have additional use of the Grasp device during dental treatment and complete a final questionnaire after treatment completion.
1 to 2 follow-up visits (in-person) depending on clinic
Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Vestland, Norway, 5021
Actively Recruiting
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Research Team
M
Mette Engan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations.
Patrick J McGrath, Gary A Walco, Dennis C Turk...
https://pubmed.ncbi.nlm.nih.gov/18562251Psychological interventions for needle-related procedural pain and distress in children and adolescents.
Kathryn A Birnie, Melanie Noel, Christine T Chambers...
https://pubmed.ncbi.nlm.nih.gov/30284240Active versus passive distraction for reducing procedural pain and anxiety in children: a meta-analysis and systematic review.
Ting Shen, Xixi Wang, Qiaoyun Xue...
https://pubmed.ncbi.nlm.nih.gov/37653423