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

NCT06984939 | Recruiting

• 1 other identifier: 873256
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Active distraction; Procedural pain; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Self-reported pain

  Self-reported by a combined visual analogue scale and numerical rating scale (0-10)

  Immediately after the procedure has been completed.

Secondary Outcomes (2)

• Self-reported distress

  Reported immediately after the procedure has been completed

• Parental-reported pain and distress

  Reported immediately after the procedure has been completed

Study Arms (2)

Control

NO INTERVENTION

Grasp

EXPERIMENTAL

Participants assigned to the Grasp arm will be instructed to use Grasp during the procedure.

Device: Grasp

Interventions

Grasp DEVICE

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.

Also known as: Active distraction

Grasp

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written consent has been obtained from the parents or legal guardians.
• Age 8-15 years old
• One of the following:
• Attend the Child and Youth Clinic at Haukeland University Hospital for peripheral venous cannula insertion
• Attend the Helsebanken in Øystese for blood sampling
• Attend TKVestland for planned dental treatment involving local anesthesia administered via injection (needle)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: collaborator
• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

Related Publications (4)

• Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.

  PMID: 30362982 BACKGROUND

• McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.

  PMID: 18562251 BACKGROUND

• Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4.

  PMID: 30284240 BACKGROUND

• Shen T, Wang X, Xue Q, Chen D. Active versus passive distraction for reducing procedural pain and anxiety in children: a meta-analysis and systematic review. Ital J Pediatr. 2023 Aug 31;49(1):109. doi: 10.1186/s13052-023-01518-4.

  PMID: 37653423 BACKGROUND

Related Links

• Information about the study

MeSH Terms

Conditions

Pain; Pain, Procedural

Interventions

Hand Strength

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mette Engan, PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Engan, PhD

CONTACT

004741106563; mette.engan@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 22, 2025
• Study Start: May 27, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)