Healthy InfantsPhase 3NCT01601197
A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization
A Phase 3 study testing Tactile stimulation in people with Healthy Infants and Immunization, run by University of Toronto at 1 site in Canada.
Trial summary
Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants, Immunization, Pain Management
- What is being tested?
- Tactile stimulation
- 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
- 120 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to May 2013
- Phase
- Phase 3
- 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 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto
Who cannot join
- impaired neurological development
- history of seizure
- use of topical anesthetics
- use of sedatives or narcotics within 24 hours
- fever or illness that would prevent administration of vaccine
- prior participation in the trial
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Dr. Tommy Ho Pediatric Clinic
Toronto, Ontario, M5G 1Z6
Anna Taddio, PhD, 416-978-8822, anna.taddio@utoronto.ca
Mary-Ellen Hogan, PharmD, 416-978-1466, me.hogan@utoronto.ca
About this study
Official title: A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization
Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.
Read the detailed description
Immunization injections are a significant source of pain for infants. At present, effective and feasible pain-relieving interventions include sugar water, fast injection without aspiration, and holding infants during the procedure. These methods, however, do not eliminate pain in all infants. Additional interventions are therefore needed.
Tactile stimulation (rubbing/applying pressure) has been shown to reduce injection pain in children and adults, and may be a suitable intervention for infant injections. It is cost neutral, requires no preparation, and is easily incorporated into practice.
The aim of this study is to determine the effectiveness of tactile stimulation when added to other proven analgesic interventions on reducing pain during infant immunization injections.
- Conditions
- Healthy Infants, Immunization, Pain Management
- Being tested
- Tactile stimulation
- Keywords
- immunization, pain management, infants, tactile stimulation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile stimulationBehavioural
Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
| Study group | Role | What they receive |
|---|---|---|
| Tactile stimulation | Experimental | Ipsilateral limb will be rubbed immediately before, during and after immunization injection(s) Receives: Behavioral: Tactile stimulation |
| No tactile stimulation | No intervention | There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Pain as assessed by the Modified Behavioral Pain Scale
assessed from videotaped procedure
Measured: First 15 seconds after injection
Secondary outcomes (3)
Parent rating of infant pain using the Numerical Rating Scale
Measured: first minute after injection
Immunizer rating of infant pain using the Numerical Rating Scale
Measured: first minute after injection
Infant crying time
assessed from videotaped procedure
Measured: duration of crying after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601197
- Sponsor's protocol ID
- 27518
- Status last verified
- Oct 2012
- First submitted
- 13 May 2012
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Taddio A, Ho T, Vyas C, Thivakaran S, Jamal A, Ilersich AF, Hogan ME, Shah V. A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants. Clin Pediatr (Phila). 2014 Jun;53(7):639-44. doi: 10.1177/0009922814526976. Epub 2014 Mar 14.
PubMed 24634424
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization
- ClinicalTrials.gov ID
- NCT01601197
- Acronym / sponsor ID
- 27518
- Conditions
- Healthy Infants, Immunization, Pain Management
- Keywords
- immunization, pain management, infants, tactile stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 17 May 2012 (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.
Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.
Detailed description
Immunization injections are a significant source of pain for infants. At present, effective and feasible pain-relieving interventions include sugar water, fast injection without aspiration, and holding infants during the procedure. These methods, however, do not eliminate pain in all infants. Additional interventions are therefore needed.
Tactile stimulation (rubbing/applying pressure) has been shown to reduce injection pain in children and adults, and may be a suitable intervention for infant injections. It is cost neutral, requires no preparation, and is easily incorporated into practice.
The aim of this study is to determine the effectiveness of tactile stimulation when added to other proven analgesic interventions on reducing pain during infant immunization injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tactile stimulation | Experimental | Behavioral: Tactile stimulationIpsilateral limb will be rubbed immediately before, during and after immunization injection(s) |
| No tactile stimulation | No intervention | –There will be no tactile stimulation of ipsilateral limb before, during and after immunization injection(s) |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto
Key exclusion criteria (6 listed)
- impaired neurological development
- history of seizure
- use of topical anesthetics
- use of sedatives or narcotics within 24 hours
- fever or illness that would prevent administration of vaccine
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 |
|---|---|---|
| Tactile stimulationImmunizer will rub the ipsilateral limb before, during and after immunization injection(s) | Behavioural | Tactile stimulation |
Primary outcome
Infant Pain as assessed by the Modified Behavioral Pain Scale
Time frame: First 15 seconds after injection
assessed from videotaped procedure
3 secondary outcomes
Parent rating of infant pain using the Numerical Rating Scale
Time frame: first minute after injection
Immunizer rating of infant pain using the Numerical Rating Scale
Time frame: first minute after injection
Infant crying time
Time frame: duration of crying after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
- Derived from this study: PubMed 24634424Taddio A, Ho T, Vyas C, Thivakaran S, Jamal A, Ilersich AF, Hogan ME, Shah V. A randomized controlled trial of clinician-led tactile stimulation to reduce pain during vaccination in infants. Clin Pediatr (Phila). 2014 Jun;53(7):639-44. doi: 10.1177/0009922814526976. Epub 2014 Mar 14.
Related trials for Healthy Infants
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
RecruitingObservational study
Impact of Delivery Mode on Infant Gut Microbiota, Visceral Sensitivity, and the Neuroenteric System
Healthy Newborn Infants
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
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.
Anna Taddio, PhD principal investigator
Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2 Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tactile stimulation in people with Healthy Infants and Immunization, run by University of Toronto at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2012. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Taddio, PhD (416-978-8822, anna.taddio@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Pain as assessed by the Modified Behavioral Pain Scale (time frame: First 15 seconds after injection). 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 NCT01601197, which also lists 1 linked publication.
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 24 Oct 2012.