Postpartum WomenPhase 3IIAPNCT01937143
A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
A Phase 3 study testing Low intensity intervention and High intensity intervention in people with Postpartum Women, run by University of Toronto at 1 site in Canada.
Trial summary
Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Women
- What is being tested?
- Low intensity intervention and High intensity intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,420 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Sep 2018
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mothers rooming in with infants on postnatal ward
Who cannot join
- mothers with significant psychiatric conditions
- mothers unable to communicate in English
- mothers sharing room whereby another mother already participated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.
- Conditions
- Postpartum Women
- Being tested
- Low intensity intervention, High intensity intervention, Control
- Keywords
- parent education, immunization, vaccination, infant, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity interventionBehavioural
Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
High intensity interventionBehavioural
Pamphlet and video with information about pain management during immunizations at birth of a newborn infant
ControlBehavioural
General information about infant immunizations at birth of a newborn infant
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | General information about infant immunizations at birth of a newborn infant Receives: Behavioral: Control |
| Low intensity intervention | Active comparator | Pamphlet with information about pain management during infant immunizations at birth of a newborn infant Receives: Behavioral: Low intensity intervention |
| High intensity intervention | Active comparator | Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant Receives: Behavioral: High intensity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic utilization
Parent self-reported use of any of the 3 most effective analgesic interventions (breastfeeding, sugar water, or topical anesthetics) at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.
Measured: Up to 6 months
Secondary outcomes (4)
Knowledge
Parent knowledge about effective analgesic interventions for mitigating pain at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.
Measured: Up to 6 months
Attitudes
Parent self-reported attitudes about pain/pain management at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.
Measured: Up to 6 months
Specific analgesic utilization
Parent self-reported utilization of specific analgesic interventions at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.
Measured: Up to 6 months
Immunization compliance
Parent self-reported compliance with infant immunization schedule, confirmed with health care provider if possible.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2017 (estimated)
- Study completionSep 2018 (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 Postpartum WomenStudies 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
- 3,420 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, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937143
- Sponsor's protocol ID
- 126007
- Other IDs
- 126007
- Acronym
- IIAP
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2013
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Taddio A, Shah V, Bucci L, MacDonald NE, Wong H, Stephens D. Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial. CMAJ. 2018 Oct 22;190(42):E1245-E1252. doi: 10.1503/cmaj.180175.
PubMed 30348739
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
- ClinicalTrials.gov ID
- NCT01937143
- Acronym / sponsor ID
- IIAP / 126007
- Conditions
- Postpartum Women
- Keywords
- parent education, immunization, vaccination, infant, pain management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,420 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 9 Sep 2013 (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 the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: ControlGeneral information about infant immunizations at birth of a newborn infant |
| Low intensity intervention | Active comparator | Behavioral: Low intensity interventionPamphlet with information about pain management during infant immunizations at birth of a newborn infant |
| High intensity intervention | Active comparator | Behavioral: High intensity interventionPamphlet and video with information about pain management during infant immunizations at birth of a newborn infant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mothers rooming in with infants on postnatal ward
Key exclusion criteria (3 listed)
- mothers with significant psychiatric conditions
- mothers unable to communicate in English
- mothers sharing room whereby another mother already participated
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 |
|---|---|---|
| Low intensity interventionPamphlet with information about pain management during infant immunizations at birth of a newborn infant | Behavioural | Low intensity intervention |
| High intensity interventionPamphlet and video with information about pain management during immunizations at birth of a newborn infant | Behavioural | High intensity intervention |
| ControlGeneral information about infant immunizations at birth of a newborn infant | Behavioural | Control |
Primary outcome
Analgesic utilization
Time frame: Up to 6 months
Parent self-reported use of any of the 3 most effective analgesic interventions (breastfeeding, sugar water, or topical anesthetics) at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.
4 secondary outcomes
Knowledge
Time frame: Up to 6 months
Attitudes
Time frame: Up to 6 months
Specific analgesic utilization
Time frame: Up to 6 months
Immunization compliance
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 30348739Taddio A, Shah V, Bucci L, MacDonald NE, Wong H, Stephens D. Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial. CMAJ. 2018 Oct 22;190(42):E1245-E1252. doi: 10.1503/cmaj.180175.
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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.
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 Low intensity intervention and High intensity intervention in people with Postpartum Women, 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 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: status not confirmed, as of the sponsor's last update on 21 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
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?
Analgesic utilization (time frame: Up to 6 months). 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 NCT01937143, 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 21 Sep 2016.