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Reducing Immunization Distress (RID)

NCT01379885 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2013-02-01

No results posted yet for this study

Summary

The purpose of this study is to compare the effectiveness of a more feasible method for reducing the pain and distress of childhood immunization with the standard method in use at the Pediatric Medical Group. A secondary aim is to evaluate the impact of parental involvement on the parent and child satisfaction with the immunization experience.

Study Hypotheses: In the standard, pre-kindergarten, two- or three vaccine sequence, there will be no statistically significant group differences between PPT and ST with respect to:

1. Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome);
2. Parent report of child pain using the FPS-R;
3. Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14;
4. Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales;
5. Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection.

Conditions

Interventions

BEHAVIORAL

Standard technique

Children in the ST group will receive vapocoolant spray and arm gripping adjacent to the injection site performed by MA 1(immunizer). A second MA (MA 2) will perform the visual distraction by descending contralateral arm vibration using the massage instrument (buzzer).

BEHAVIORAL

Parent participation technique

The children in the PPT group will receive the same sequence, except that the parent/caregiver will administer the visual distraction rather than by MA2

Sponsors & Collaborators

Principal Investigators

  • Linda Franck, RN,PhD · University of California, San Francisco

  • Ralph Berberich, MD · Pediatric Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01379885 on ClinicalTrials.gov