An interventional study of Grasp in Pain, sponsored by Haukeland University Hospital. Recruiting at 1 site in Norway. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Treatment
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:
This project seeks to contribute to the evidence base regarding the utility of active distraction techniques, such as Grasp, in pediatric clinical settings. Findings may inform the development of non-pharmacological interventions aimed at improving the patient experience and reducing procedural distress among children.
Grasp is a communication tool comprising both hardware and software components. The hardware consists of a handheld, soft silicone ball embedded with pressure sensors capable of detecting squeezes of varying intensity and duration. The software component is a dedicated application designed for use on an iPad, which forms an integral part of the system. Squeezing the ball generates visual and auditory feedback in real time via the application, presented through dynamic curves and sound cues, including musical elements. Data from the pressure sensors is transmitted live to the software via Bluetooth, enabling immediate sensory feedback. Grasp is CE-marked and registered as a medical device under ID NO918873724/0943-55311 by the Norwegian Directorate of Medical Products.
The primary objective of this study is to evaluate the efficacy of Grasp as an active distraction tool in reducing perceived pain and distress in children undergoing minor but potentially distressing medical procedures. We aim to recruit children aged 8-15 years from Children and Youth Clinic (CYC) at Helse Bergen HF, Helsebanken General Practice, and TkVestland Dental Center. The procedures involved include peripheral venous cannulation (CYC), venipuncture for blood sampling (Helsebanken), and administration of local anesthesia via injection (dental clinic). Participants will be allocated using block randomization. The intervention group will engage with the Grasp system by repeatedly squeezing the ball before and during the procedure, triggering musical feedback. The control group will undergo standard care without the use of Grasp.
We aim to recruit 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 diabetes mellitus type 1 who will use Grasp during blood sugar measurement or subcutaneous insulin administration. (These six participants will not participate in the randomized controlled part of the study.)
The primary outcome measure will be self-reported pain, assessed using a combined visual analogue scale (VAS) and numeric rating scale (NRS) (0-10). The secondary outcomes will include self-reported distress, measured using a combined VAS/NRS scale, as well as parents' or legal guardians' assessments of their child's pain and distress, also rated on a similar scale. Additionally, six participants recruited at CYC who have prior experience with peripheral venous cannulation and underwent the procedure using Grap, will be invited to take part in individual semi-structured interviews. These interviews will explore their subjective experiences with the intervention.
The participant will fill out a paper form questionnaire prior to randomization regarding their prior experience, anticipated pain and how anxious they are about the upcoming procedure. Immediately after the needle prick procedure participants and parents will fill out the second form regarding their experience during this procedure. The participant at the dental office will be offered to use the Grasp further through the dental treatment and all participants and parents at the dental office will complete a final similar questionnaire after the completion of dental treatment.
Multiple linear regression analyses will performed to examine the impact of the intervention adjusted for baseline scores. Statistical analyses will be done in R version 4.2.3. Systematic text condensation will be used to analyse the interviews.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 126 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Haukeland University Hospital is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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One of the following:
Exclusion Criteria:
Participants assigned to the Grasp arm will be instructed to use Grasp during the procedure.
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.
Also known as: Active distraction
Self-reported pain
Self-reported by a combined visual analogue scale and numerical rating scale (0-10)
Time frame: Immediately after the procedure has been completed.
Self-reported distress
Self-reported by a combined visual analogue scale and numeric rating scale ( 0-10)
Time frame: Reported immediately after the procedure has been completed
Parental-reported pain and distress
Reported by a combined visual analogue scale and numeric rating scale ( 0-10)
Time frame: Reported immediately after the procedure has been completed
Plan to share: No
Started May 2025 (actual). Primary completion is estimated for May 2026, 11 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 11 months is close to that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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