Reducing Immunization Distress (RID)

Not Applicable

Terminated

Interventions: Behavioral: Standard technique
Behavioral: Parent participation technique

Brief 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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Standard technique	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).
Parent participation technique	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations (1): Pediatric Medical Group
🇺🇸
Berkeley, California, United States