ImmunizationPhase 3NCT01707212
Prenatal Education About Infant Immunization Pain Management
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
There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy 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
- 197 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Jul 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- mothers attending weekend prenatal classes
- delivery of a healthy newborn > 35 weeks gestational age
- available for followup for infant's 2-month immunization
Who cannot join
- mothers who do not plan to immunize their infants
- infant with major birth defect or hospitalized at time of immunization
- mothers who need to attend the prenatal class at a separate time when education not offered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation
There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.
Read the detailed description
There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.
- 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
Education about pain management during infant immunization
No pain management educationBehavioural
Control - no education about pain management during infant immunization
| Study group | Role | What they receive |
|---|---|---|
| Pain management education | Experimental | Education about pain management during infant immunization Receives: Behavioral: Pain management education |
| No pain management education | Other | Control - general information about immunization only Receives: Behavioral: No pain management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of pain management strategies during infant immunization
Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization
Measured: within 2 months of immunization
Secondary outcomes (2)
Attempted use of pain management strategies during infant immunization
Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization
Measured: within 2 months of immunization
Knowledge
Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections
Measured: within 2 months of immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
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.
- 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
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, New York
- Responsible party
- Principal investigator, Anna Taddio, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707212
- Sponsor's protocol ID
- 12-0134-E
- Status last verified
- Oct 2013
- First submitted
- 11 Oct 2012
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation
- ClinicalTrials.gov ID
- NCT01707212
- Acronym / sponsor ID
- 12-0134-E
- Conditions
- Immunization
- Keywords
- parent education, pain management, immunization, infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, New York
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 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.
There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.
Detailed description
There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month 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 |
|---|---|---|
| Pain management education | Experimental | Behavioral: Pain management educationEducation about pain management during infant immunization |
| No pain management education | Other | Behavioral: No pain management educationControl - general information about immunization only |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- mothers attending weekend prenatal classes
- delivery of a healthy newborn > 35 weeks gestational age
- available for followup for infant's 2-month immunization
Key exclusion criteria (3 listed)
- mothers who do not plan to immunize their infants
- infant with major birth defect or hospitalized at time of immunization
- mothers who need to attend the prenatal class at a separate time when education not offered
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 educationEducation about pain management during infant immunization | Behavioural | Pain management education |
| No pain management educationControl - no education about pain management during infant immunization | Behavioural | No pain management education |
Primary outcome
Utilization of pain management strategies during infant immunization
Time frame: within 2 months of immunization
Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization
2 secondary outcomes
Attempted use of pain management strategies during infant immunization
Time frame: within 2 months of immunization
Knowledge
Time frame: within 2 months of immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 Oct 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Utilization of pain management strategies during infant immunization (time frame: within 2 months of 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 29 Oct 2013; AzTrials last refreshed its copy on 3 Nov 2026.