Reducing Immunization Distress (RID)
Stopped early · Not applicable
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01379885
- Run by
- University of California, San Francisco
- People needed
- 77
- Starts
- 2011-06-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2013-02-01
Who can join
Age: 4 and older, up to 6. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Children, ages 4-6 years, scheduled to receive the standard pre-kindergarten immunizations. This consists of two injections: the Dtap (diphtheria, tetanus, acellular pertussis) and IPV (injectable polio vaccine) or three injections: DTAP, IPV and MMR (measles, mumps, rubella);
- With or without prior exposure to ST at PMG;
- English speaking subject and parents
You may not qualify if…
- Acute concurrent illness;
- Invasive procedures such as cannulation, venipuncture or urinary VCG in the preceding 6 months;
- Hospitalization or ED visit, within the prior 6 months;
- Chronic medical conditions requiring repeated painful interventions;
- Inability to respond age appropriately with verbal and written answers to questions, to pain scale measures, or to questionnaires;
- Refusal to be videotaped.
Where it is running
- Pediatric Medical Group — Berkeley, California, United States
Full record on ClinicalTrials.gov
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