Procedural Pain
Conditions
Keywords
Pain
Brief summary
The hypothesis of this study is that distraction cards used by the caretaker along with a vibrating cold pack placed proximal to the site of immunization will decrease the pain of routine pediatric immunizations when compared to a placebo device or standard care.
Detailed description
Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10$ of adults. Current standard of care for immunizations in the US is no pain relief. An inexpensive, immediately effective form of needle pain control could reduce needle phobia or vaccine refusal in the long term if demonstrated to be effective for immunization pain. Distraction can decrease procedural distress in children by 50%. The effect of using a multi-modal pain and distraction relieving approach has not been rigorously studied.
Interventions
DEVICEDevice: Buzzy
Buzzy, the vibrating cold pack, is held in place with a velcro strap or pressed by caretaker or nurse immediately prior and during immunizations. The vibration is activated and the device remains in place during the shot, moving locations if multiple shots are given. Distraction cards with pictures on one side and questions on the other are shown to the child while the caretaker asks the finding and seeking questions on the back.
DEVICEBuzzy: sham device
The identical device without batteries or a cold pack is held in place proximal to the site with a velcro strap or pressed by parent or nurse immediately prior to immunizations. The device remains in place throughout the procedure, moving locations to complete multiple shots.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
MMJ Labs LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* children receiving routine immunizations
Exclusion criteria
* no caregiver present * chronic illness requiring frequent injections * clear cognitive impairments affecting communication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain of immunization | 5 minutes during or immediately after immunizations | Infants' and toddlers' pain is assessed by coding videotapes using the FLACC (face, legs, activity, crying and consolability) scale. Patients age 4 and older rate pain using self-report via the Faces Pain Scale Revised. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain from immunization using observational measures | 5 minutes immediately following immunization | Caretakers and nurses administering the shots rate pain using a 10cm Visual analog scale from no pain to most pain possible; duration of infant cry is also assessed following the procedure using coded videotape recordings. |
| Treatment satisfaction | 5 minutes after immunizations | 10 item scale ranging from strongly agree to strongly disagree with ten parameters of satisfaction with the methods and concepts of immunization. |
Outcome results
None listed