Reducing Immunization Distress (RID)

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

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Behavioral: Standard technique
* Behavioral: Parent participation technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard technique<br>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: Standard technique<br>* 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).<br>|
| Experimental: Parent participation technique<br>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 | Behavioral: Parent participation technique<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child pain intensity | Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale (primary outcome); Parent report of child pain using the FPS-R. | 2 minutes after completion of the immunization series. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for completion of immunization | Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection. | From the start of the procedure to 2 minutes after completion of the immunization series. | 
| Child and parent satisfaction with procedure | Child and parent self-reported satisfaction with the procedure using a 5-item questionnaire developed specifically for the study. | 2 minutes after completion of the immunization series. | 
| Child pain intensity | Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale | Immediately before, and after injection in each arm. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, immunization, distraction, hypnosis, injections, anxiety