Reducing Immunization Distress (RID) — RID  

Pain Clinical Trial

Official title: Childhood Immunization: Reducing Immunization Distress (RID) Using Multi-Modal Distraction

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

• Pain

• NCT number: NCT01379885
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Terminated
• Phase: N/A
• Start date: June 2011
• Completion date: January 2013