PainRIDNCT01379885
Reducing Immunization Distress (RID)
A study testing Standard technique and Parent participation technique in people with Pain, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Standard technique and Parent participation technique
- Type of treatment
- Vaccines, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome);
- Parent report of child pain using the FPS-R;
- Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14;
- Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales;
- Time required for completion of immunization from initiation of ST or PPT to 2 minutes after completion of the last injection.
Read the 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
- Being tested
- Standard technique, Parent participation technique
- Keywords
- Pain, immunization, distraction, hypnosis, injections, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard techniqueBehavioural
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 techniqueBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Behavioral: Parent participation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 minutes after completion of the immunization series.
Secondary outcomes (3)
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.
Measured: From the start of the procedure to 2 minutes after completion of the immunization series.
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.
Measured: 2 minutes after completion of the immunization series.
Child pain intensity
Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale
Measured: Immediately before, and after injection in each arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Estimated sample size not achieved due to decline in number of eligible patients and difficulty recruiting and retaining research staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Medical Group
- Responsible party
- Principal investigator, Linda Franck, University of California, San Francisco
- Investigators
- Linda Franck, RN,PhD, Principal investigator, University of California, San FranciscoRalph Berberich, MD, Principal investigator, Pediatric Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379885
- Sponsor's protocol ID
- UCaliforniaSF
- Acronym
- RID
- Status last verified
- Jan 2013
- First submitted
- 13 Jun 2011
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14609903Taddio 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.
PubMed 19781434Taddio 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.
PubMed 21098067Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.
PubMed 7636457Taddio 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.
PubMed 21098062Taddio 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.
PubMed 17766503Parvez 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.
PubMed 21532793Schechter 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.
PubMed 21078736Berberich 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.
PubMed 19596729Barnhill 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.
PubMed 8718917Chung 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.
PubMed 12100641Taddio 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.
PubMed 20483194Hicks 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.
PubMed 11427329Merkel 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.
PubMed 9220806Franck 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.
PubMed 25475591
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Immunization: Reducing Immunization Distress (RID) Using Multi-Modal Distraction
- ClinicalTrials.gov ID
- NCT01379885
- Acronym / sponsor ID
- RID / UCaliforniaSF
- Conditions
- Pain
- Keywords
- Pain, immunization, distraction, hypnosis, injections, anxiety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Estimated sample size not achieved due to decline in number of eligible patients and difficulty recruiting and retaining research staff.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Pediatric Medical Group
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Child self-reported pain using the Faces Pain Scale-Revised (FPS-R) scale13 (primary outcome);
- Parent report of child pain using the FPS-R;
- Observer-rated child distress and pain using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale14;
- Parent and child satisfaction with pain management during immunization measured by a 5-point Likert type scales;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard technique | Active comparator | Behavioral: Standard techniqueChildren 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 | Experimental | Behavioral: Parent participation techniqueThe children in the PPT group will receive the same sequence, except that the parent/caregiver will administer the visual distraction rather than by MA2 |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard techniqueChildren 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). | Behavioural | Standard technique |
| Parent participation techniqueThe children in the PPT group will receive the same sequence, except that the parent/caregiver will administer the visual distraction rather than by MA2 | Behavioural | Parent participation technique |
Primary outcome
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.
3 secondary outcomes
Time for completion of immunization
Time frame: 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 pain intensity
Time frame: Immediately before, and after injection in each arm.
Results and safety
The study was stopped early (reason given: Estimated sample size not achieved due to decline in number of eligible patients and difficulty recruiting and retaining research staff.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
- Background: PubMed 14609903Reis 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.
- Background: PubMed 19781434Taddio 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.
- Background: PubMed 21098067Taddio 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.
- Background: PubMed 7636457Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.
- Background: PubMed 21098062Taddio 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.
- Background: PubMed 17766503Taddio 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.
- Background: PubMed 21532793Parvez 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.
- Background: PubMed 21078736Schechter 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.
- Background: PubMed 19596729Berberich 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.
- Background: PubMed 8718917Barnhill 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.
- Background: PubMed 12100641Chung 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.
- Background: PubMed 20483194Taddio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Franck, RN,PhD principal investigator
University of California, San Francisco
Ralph Berberich, MD principal investigator
Pediatric Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard technique and Parent participation technique in people with Pain, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Estimated sample size not achieved due to decline in number of eligible patients and difficulty recruiting and retaining research staff.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child pain intensity (time frame: 2 minutes after completion of the immunization series.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01379885, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013.