ImmunizationPhase 3NCT01713322
Testing Educational Materials in a Paediatric Setting
A Phase 3 study testing Pain management education and No pain management education in people with Immunization, run by University of Toronto at 1 site in Canada.
Trial summary
Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline, led by Taddio et al., created evidence-based strategies for management of immunization pain. User-friendly educational tools outlining these strategies were made. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunization
- What is being tested?
- Pain management education and No pain management education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Sep 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of 2 or 4-month old healthy infants during routine immunization appointments
- Parent accompanies infant at immunization appointments
Who cannot join
- Parents of infants <30 weeks gestational age (GA)
- Parents delaying infant immunization for >2 months
- Parents who are unable to read and understand English
- Infants with congenital anomalies, neurological conditions, and maternal psychiatric conditions
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Health Center, Pediatric Clinic.
Toronto, Ontario, M5B 1W8
Micheal Sgro, MD, 416-864-6060 ext. 6560, SgroM@smh.ca
Anna Taddio, PhD, 416-978-8822, anna.taddio@utoronto.ca
About this study
Official title: Testing Educational Materials About Immunizations in a Paediatric Setting
Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline, led by Taddio et al., created evidence-based strategies for management of immunization pain. User-friendly educational tools outlining these strategies were made. The goal of cluster randomized controlled trial is to assess whether these educational materials increase utilization of pain-relieving strategies by parents during infant immunizations.
Read the detailed description
Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline led by Taddio et al. provides evidence-based recommendations for the management of immunization pain in children. User-friendly educational tools based on the guideline have also been developed, including a factsheet and educational video. The primary objective of this study is to assess whether these materials can increase utilization of pain -relieving strategies by parents during immunizations. Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive either the educational material related to immunization pain management (intervention group) or general information about immunization (control group). The study team will then follow these infants at their current and upcoming immunizations visit and document the pain management strategies utilized, infant pain responses, and parental satisfaction with pain management.
- Conditions
- Immunization
- Being tested
- Pain management education, No pain management education
- Keywords
- parent education, pain management, immunization, infant
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain management educationBehavioural
Parents are provided with educational material on how to manage child pain during immunization.
No pain management educationBehavioural
Control - parents receive general information about childhood immunization.
| Study group | Role | What they receive |
|---|---|---|
| Pain management education | Experimental | Parents are provided with educational material on how to manage child pain during immunization. Receives: Behavioral: Pain management education |
| No pain management education | Other | Control - parents receive general information about childhood immunization. Receives: Behavioral: No pain management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pain management strategies utilized
The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.
Measured: During immunization
Secondary outcomes (6)
Pain during infant immunizations
Pain during infant immunizations, as measured by a validated measure of pain in infants, the Modified Behavioural Pain Scale (MBPS), by trained and blinded research assistants.
Measured: During immunization
Parent behaviour during infant immunizations
Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants.
Measured: During immunization
Pain during infant immunizations as reported by parents
Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time.
Measured: During immunization
Parent-reported satisfaction with immunization experience
Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale.
Measured: During immunization
Duration of infant crying during immunizations
Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor.
Measured: During immunization
Pain during infant immunizations
Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)
Measured: During immunizations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
- Investigators
- Anna Taddio, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713322
- Sponsor's protocol ID
- 12-195C
- Status last verified
- Dec 2012
- First submitted
- 21 Oct 2012
- Last updated
- 24 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Educational Materials About Immunizations in a Paediatric Setting
- ClinicalTrials.gov ID
- NCT01713322
- Acronym / sponsor ID
- 12-195C
- Conditions
- Immunization
- Keywords
- parent education, pain management, immunization, infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (estimated)
- First posted
- 24 Oct 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 procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline, led by Taddio et al., created evidence-based strategies for management of immunization pain. User-friendly educational tools outlining these strategies were made. The goal of cluster randomized controlled trial is to assess whether these educational materials increase utilization of pain-relieving strategies by parents during infant immunizations.
Detailed description
Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline led by Taddio et al. provides evidence-based recommendations for the management of immunization pain in children. User-friendly educational tools based on the guideline have also been developed, including a factsheet and educational video. The primary objective of this study is to assess whether these materials can increase utilization of pain -relieving strategies by parents during immunizations. Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive either the educational material related to immunization pain management (intervention group) or general information about immunization (control group). The study team will then follow these infants at their current and upcoming immunizations visit and document the pain management strategies utilized, infant pain responses, and parental satisfaction with pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain management education | Experimental | Behavioral: Pain management educationParents are provided with educational material on how to manage child pain during immunization. |
| No pain management education | Other | Behavioral: No pain management educationControl - parents receive general information about childhood immunization. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents of 2 or 4-month old healthy infants during routine immunization appointments
- Parent accompanies infant at immunization appointments
Key exclusion criteria (4 listed)
- Parents of infants <30 weeks gestational age (GA)
- Parents delaying infant immunization for >2 months
- Parents who are unable to read and understand English
- Infants with congenital anomalies, neurological conditions, and maternal psychiatric conditions
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 |
|---|---|---|
| Pain management educationParents are provided with educational material on how to manage child pain during immunization. | Behavioural | Pain management education |
| No pain management educationControl - parents receive general information about childhood immunization. | Behavioural | No pain management education |
Primary outcome
Number of pain management strategies utilized
Time frame: During immunization
The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.
6 secondary outcomes
Pain during infant immunizations
Time frame: During immunization
Parent behaviour during infant immunizations
Time frame: During immunization
Pain during infant immunizations as reported by parents
Time frame: During immunization
Parent-reported satisfaction with immunization experience
Time frame: During immunization
Duration of infant crying during immunizations
Time frame: During immunization
Pain during infant immunizations
Time frame: During immunizations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2012.
Related trials for Immunization
RecruitingPhase 4
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
Vaccination, Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Recruiting
Distraction Cards Versus Emotion-Regulation Toy Squeezing During Intramuscular Vaccination in Preschool Children
Procedural Pain, Pain-related Fear
RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Malaria
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease
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
University of Toronto
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 Pain management education and No pain management education in people with 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 2 inclusion and 4 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 Dec 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?
Number of pain management strategies utilized (time frame: During immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2012.