A Handheld Tool for Active Distraction of Children and Adolescents During Painful Procedures
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-15
SponsorHaukeland University Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written consent has been obtained from the parents or legal guardians.
Age 8-15 years old
Attend the Child and Youth Clinic at Haukeland University Hospital for peripheral venous cannula insertion
Attend the Helsebanken in Øystese for blood sampling
Disqualifiers
Moderate to severe intellectual disability
Impaired vision or hearing
Does not understand the Norwegian language
General condition affected by illness
Trial design
Design model
Parallel
Treatments tested in this trial
Grasp
DeviceParticipants 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.
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: GraspExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 completed2
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 completedSponsors and contacts
Click on the lead sponsor to view all of their trials.
Haukeland University Hospital
Lead sponsor
University of Bergen
Collaborator
Source ClinicalTrials.gov