None listed
Conditions
Brief summary
The aim of the proposed study, 'Minimising Immunisatin Pain in Younger Children (MIPY) is to evaluate the efficacy of two novel devices, Coolsense® (cools and numbs the skin) and Buzzy® (vibration) with cooling pads (wings) versus standard care, and to minimise pain during immunisations in younger (aged 3.5 - 9 years inclusive) children (MIPY). Outcome measures will include 1. Child/adolescent self report of pain using the Wong Baker Faces pain rating scale, 2. Parent assessment of their child's fear/anxiety using the Child Fear Scale (CFS) (Pre and post procedure), 3. Nurse assessment of child's fear/anxiety using the CFS scale (Pre and post procedure) 4. Nurse report of observed pain using the VAS Scale, 5. Parent perception of usefulness of Intervention and Nurse observed compliance with intervention. We estimate it will take up to 6 months to recruit the required number of children for these studies based on 75% uptake of those that meet the inclusion criteria. The study groups will be assigned randomly by a computer. It is hoped 492 children will participate in this study, with 164 participants in each group. Before each child has their vaccine, we will either apply Buzzy® (with the cooling pad) or the Coolsense®device, or use the standard distraction method (blowing bubbles). Possible outcomes will be reduced pain and fear/anxiety scores and improved patient and family experience of vaccination.
Interventions
The intervention devices to be used in the study will be the Coolsense® device and Buzzy® device. Coolsense® is fully registered with the Therapeutics Goods Administration (2013) and is a reusable, non-invasive hand-held device that immediately cools and numbs the skin
at the site of injection. Buzzy® is a vibrating handheld device used to help block sharp pain and provide distraction when giving injections to children. A frozen cooling pad (wings) is placed behind Buzzy® before the device is p
The intervention devices to be used in the study will be the Coolsense® device and Buzzy® device. Coolsense® is fully registered with the Therapeutics Goods Administration (2013) and is a reusable, non-invasive hand-held device that immediately cools and numbs the skin at the site of injection. Buzzy® is a vibrating handheld device used to help block sharp pain and provide distraction when giving injections to children. A frozen cooling pad (wings) is placed behind Buzzy® before the device is placed on the child's arm. Participants will be randomised into one of three arms: Arm 1. Coolsense®, Arm 2. Buzzy® (with cooling pads) and Arm 3. Standard Care (distraction using Bubbles). If the participant is randomised to Arm 1., then the Coolsense® device will be placed on the child's arm at the site of injection for a count of 10 seconds. As soon as the device is removed (after the 10 seconds), the immunisation will be given. If the participant is randomised to Arm 2., then the Buzzy® device will be placed on the child/adolescent's arm at the site of injection for a count of 30 seconds. After 30 seconds the device is left on and lifted up the arm and the immunisation given immediately (below the Buzzy device). The interventions (Buzzy®, Coolsense® or standard care) are used for the first injection only during the episode of care. The Immunisation Nurse will administer the intervention the participant has been randomised into.
Sponsors
The Royal Childrens Hospital Foundation
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
3 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
All children aged 3.5 to 9 years of age inclusive presenting with their parents/guardians to the Royal Children’s Hospital Immunisation Service Drop-in Centre for immunisations.
Exclusion criteria
Children will be excluded if: 1. Child with needle phobia (defined by:fear of medical needle procedure and/or recent prior failure to vaccinate due to fear/distress of the procedure). 2. Child with Haemophilia or other bleeding disorders that require deep subcutaneous injections rather than intramuscular. 3. Child with damage to the skin at the site of injection E.G. Overlying Eczema 4. Child with developmental/behavioural disorders that may prevent them from being able to complete the Wong Baker Faces scale.
Outcome results
None listed