Reducing Immunization Distress (RID)
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2011 |
| End Date: | June 2013 |
| Contact: | Ralph F Berberich, MD |
| Email: | rberb@sbcglobal.net |
| Phone: | (510) 409-9399 |
Childhood Immunization: Reducing Immunization Distress (RID) Using Multi-Modal Distraction
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, 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.
Berberich and Landman conducted a randomized clinical trial demonstrating efficacy of a
multimodal distraction technique to reduce immunization distress (RID) in 4-6 year old
children receiving pre-kindergarten immunizations. Widespread implementation would require
fewer steps and a reduction of personnel and the current study addresses the practical time
and personnel limitations of the method. The current RID trial proposes a randomized design
to compare our current method, the standard technique, (ST), with its minimally altered
approach where arm gripping and rubbing adjacent to the injection site are to be performed
by the medical assistant conducting the injection, substituting for the non-commercially
available 'arm gripper'. Pressure and rubbing stimuli at injection sites are documented to
be equally effective. The ST will be compared against the parental participation technique,
(PPT), whereby the parent participates in the delivery of pain-relieving interventions in
lieu of the second medical assistant. The primary aim of the present proposal is to compare
the effectiveness of the more feasible PPT to the ST in reducing the pain and distress of
childhood immunization. A secondary aim is to evaluate the impact of parental involvement on
the parent and child satisfaction with the immunization experience.
Inclusion Criteria:
- Children, ages 4-6 years, scheduled to receive three standard pre-kindergarten
immunizations, the Dtap (diphtheria, tetanus, acellular pertussis), IPV (injectable
polio vaccine) and MMR (measles, mumps, rubella);
- With or without prior exposure to ST at PMG;
- English speaking subject and parents
Exclusion Criteria:
- 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.
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