Reducing Immunization Distress (RID)

NCT ID: NCT01379885

Last Updated: 2013-02-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-01-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Standard technique

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Parent participation technique

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pediatric Medical Group

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Linda Franck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda Franck, RN,PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Ralph Berberich, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Medical Group

Locations

Pediatric Medical Group

Berkeley, California, United States

Countries

United States

References

Reis EC, Roth EK, Syphan JL, Tarbell SE, Holubkov R. Effective pain reduction for multiple immunization injections in young infants. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1115-20. doi: 10.1001/archpedi.157.11.1115.

Reference Type: BACKGROUND

PMID: 14609903 (View on PubMed)

Taddio A, Chambers CT, Halperin SA, Ipp M, Lockett D, Rieder MJ, Shah V. Inadequate pain management during routine childhood immunizations: the nerve of it. Clin Ther. 2009;31 Suppl 2:S152-67. doi: 10.1016/j.clinthera.2009.07.022.

Reference Type: BACKGROUND

PMID: 19781434 (View on PubMed)

Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline (summary). CMAJ. 2010 Dec 14;182(18):1989-95. doi: 10.1503/cmaj.092048. Epub 2010 Nov 22. No abstract available.

Reference Type: BACKGROUND

PMID: 21098067 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7636457 (View on PubMed)

Taddio A, Appleton M, Bortolussi R, Chambers C, Dubey V, Halperin S, Hanrahan A, Ipp M, Lockett D, MacDonald N, Midmer D, Mousmanis P, Palda V, Pielak K, Riddell RP, Rieder M, Scott J, Shah V. Reducing the pain of childhood vaccination: an evidence-based clinical practice guideline. CMAJ. 2010 Dec 14;182(18):E843-55. doi: 10.1503/cmaj.101720. Epub 2010 Nov 22. No abstract available.

Reference Type: BACKGROUND

PMID: 21098062 (View on PubMed)

Taddio A, Manley J, Potash L, Ipp M, Sgro M, Shah V. Routine immunization practices: use of topical anesthetics and oral analgesics. Pediatrics. 2007 Sep;120(3):e637-43. doi: 10.1542/peds.2006-3351.

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Reference Type: BACKGROUND

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Schechter NL, Bernstein BA, Zempsky WT, Bright NS, Willard AK. Educational outreach to reduce immunization pain in office settings. Pediatrics. 2010 Dec;126(6):e1514-21. doi: 10.1542/peds.2010-1597. Epub 2010 Nov 15.

Reference Type: BACKGROUND

PMID: 21078736 (View on PubMed)

Berberich FR, Landman Z. Reducing immunization discomfort in 4- to 6-year-old children: a randomized clinical trial. Pediatrics. 2009 Aug;124(2):e203-9. doi: 10.1542/peds.2007-3466. Epub 2009 Jul 13.

Reference Type: BACKGROUND

PMID: 19596729 (View on PubMed)

Barnhill BJ, Holbert MD, Jackson NM, Erickson RS. Using pressure to decrease the pain of intramuscular injections. J Pain Symptom Manage. 1996 Jul;12(1):52-8. doi: 10.1016/0885-3924(96)00049-8.

Reference Type: BACKGROUND

PMID: 8718917 (View on PubMed)

Chung JW, Ng WM, Wong TK. An experimental study on the use of manual pressure to reduce pain in intramuscular injections. J Clin Nurs. 2002 Jul;11(4):457-61. doi: 10.1046/j.1365-2702.2002.00645.x.

Reference Type: BACKGROUND

PMID: 12100641 (View on PubMed)

Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.

Reference Type: BACKGROUND

PMID: 20483194 (View on PubMed)

Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

Reference Type: BACKGROUND

PMID: 11427329 (View on PubMed)

Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

Reference Type: BACKGROUND

PMID: 9220806 (View on PubMed)

Franck LS, Berberich FR, Taddio A. Parent participation in a childhood immunization pain reduction method. Clin Pediatr (Phila). 2015 Mar;54(3):228-35. doi: 10.1177/0009922814561593. Epub 2014 Dec 3.

Reference Type: DERIVED

PMID: 25475591 (View on PubMed)

Other Identifiers

UCaliforniaSF

Identifier Type: -

Identifier Source: org_study_id