NCT01379885

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

1.6 years

First QC Date

June 13, 2011

Last Update Submit

January 30, 2013

Conditions

Pain

Keywords

Painimmunizationdistractionhypnosisinjectionsanxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time for completion of immunization

    From the start of the procedure to 2 minutes after completion of the immunization series.

  • Child and parent satisfaction with procedure

    2 minutes after completion of the immunization series.

  • Child pain intensity

    Immediately before, and after injection in each arm.

Study Arms (2)

Standard technique

ACTIVE COMPARATOR

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

Parent participation technique

EXPERIMENTAL

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

Interventions

Standard techniqueBEHAVIORAL

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).

Standard technique
Parent participation techniqueBEHAVIORAL

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

Parent participation technique

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Medical Group

Berkeley, California, 94707, United States

Location

Related Publications (15)

  • 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.

    PMID: 14609903BACKGROUND

  • 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.

    PMID: 19781434BACKGROUND

  • 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.

    PMID: 21098067BACKGROUND

  • Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.

    PMID: 7636457BACKGROUND

  • 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.

    PMID: 21098062BACKGROUND

  • 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.

    PMID: 17766503BACKGROUND

  • Parvez E, Stinson J, Boon H, Goldman J, Shah V, Taddio A. Mothers' beliefs about analgesia during childhood immunization. Paediatr Child Health. 2010 May;15(5):289-93. doi: 10.1093/pch/15.5.289.

    PMID: 21532793BACKGROUND

  • 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.

    PMID: 21078736BACKGROUND

  • 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.

    PMID: 19596729BACKGROUND

  • 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.

    PMID: 8718917BACKGROUND

  • 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.

    PMID: 12100641BACKGROUND

  • 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.

    PMID: 20483194BACKGROUND

  • 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.

    PMID: 11427329BACKGROUND

  • 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.

    PMID: 9220806BACKGROUND

  • 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.

    PMID: 25475591DERIVED

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Linda Franck, RN,PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Ralph Berberich, MD

    Pediatric Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

US(1)