A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain

Procedural Pain Clinical Trial

Official title:

Phase II Study of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain in Multiple Age Groups

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152489
• Other study ID #: H09501
• Secondary ID: R44HD056647-01A2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 26, 2010
• Last updated: June 21, 2011
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: MMJ Labs LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Months to 12 Years

Eligibility

Inclusion Criteria:

• children receiving routine immunizations

Exclusion Criteria:

• no caregiver present

• chronic illness requiring frequent injections

• clear cognitive impairments affecting communication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Procedural Pain

Intervention

Device:
• Device: 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.
• Buzzy: 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MMJ Labs LLC	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain of immunization	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.	5 minutes during or immediately after immunizations	No
Secondary	Pain from immunization using observational measures	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.	5 minutes immediately following immunization	No
Secondary	Treatment satisfaction	10 item scale ranging from "strongly agree" to "strongly disagree" with ten parameters of satisfaction with the methods and concepts of immunization.	5 minutes after immunizations	No