Reducing Immunization Distress (RID)

Pain Clinical Trial

— RID  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01379885
• Other study ID #: UCaliforniaSF
• Status: Terminated
• Phase: N/A
• First received: June 13, 2011
• Last updated: January 30, 2013
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 77
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 6 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

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).
• 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

Locations

Country	Name	City	State
United States	Pediatric Medical Group	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Pediatric Medical Group

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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

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):173-83. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No