Reducing Immunization Distress (RID) (RID)

January 30, 2013 updated by: Linda Franck, University of California, San Francisco

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, 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94707
        • Pediatric Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Behavioral: 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).
Experimental: 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
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child pain intensity
Time Frame: 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.
2 minutes after completion of the immunization series.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for completion of immunization
Time Frame: 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.
From the start of the procedure to 2 minutes after completion of the immunization series.
Child and parent satisfaction with procedure
Time Frame: 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.
2 minutes after completion of the immunization series.
Child pain intensity
Time Frame: Immediately before, and after injection in each arm.
Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale
Immediately before, and after injection in each arm.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Pediatric Medical Group

Investigators

  • Principal Investigator: Linda Franck, RN,PhD, University of California, San Francisco
  • Principal Investigator: Ralph Berberich, MD, Pediatric Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 30, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCaliforniaSF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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