Mothers of Newborn InfantsPhase 3NCT01637779
A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain
A Phase 3 study testing Fact sheet in people with Mothers of Newborn Infants, run by University of Toronto at 1 site in Canada.
Trial summary
There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods. Read more about this study
- Who is it for?
- Ages 15 to 60 years, women only
- Conditions the study is for
- Mothers of Newborn Infants
- What is being tested?
- Fact sheet
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Feb 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 15 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- new mothers with health full-term infants
- 5 minute Apgar 7 or more
Who cannot join
- non-english speaking mothers
- mothers with psychiatric conditions
- infants admitted to intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge
There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.
Read the detailed description
Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.
- Conditions
- Mothers of Newborn Infants
- Being tested
- Fact sheet
- Keywords
- randomized controlled trial, parent education, pain management, infant, immunization
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fact sheetBehavioural
fact sheet about pain management during immunization
| Study group | Role | What they receive |
|---|---|---|
| fact sheet review | Experimental | mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward Receives: Behavioral: Fact sheet |
| control unrelated material | Placebo comparator | mothers will review material unrelated to pain management during immunization then complete a knowledge test Receives: Behavioral: Fact sheet |
| pre-test, review of fact sheet | Experimental | mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test Receives: Behavioral: Fact sheet |
| pre-test, control unrelated information | Placebo comparator | mothers do a pre-test, then read unrelated material, then repeat the test Receives: Behavioral: Fact sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge
maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)
Measured: 10 minutes after intervention (educational material)
Secondary outcomes (1)
utilization of pain relieving interventions
maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations
Measured: 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mothers of Newborn InfantsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- 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
- NCT01637779
- Sponsor's protocol ID
- 11-0231-E
- Other IDs
- 1000032989
- Status last verified
- Oct 2013
- First submitted
- 8 Jul 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 Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge
- ClinicalTrials.gov ID
- NCT01637779
- Acronym / sponsor ID
- 11-0231-E
- Conditions
- Mothers of Newborn Infants
- Keywords
- randomized controlled trial, parent education, pain management, infant, immunization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- Jul 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Jul 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 is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.
Detailed description
Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fact sheet review | Experimental | Behavioral: Fact sheetmothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward |
| control unrelated material | Placebo comparator | Behavioral: Fact sheetmothers will review material unrelated to pain management during immunization then complete a knowledge test |
| pre-test, review of fact sheet | Experimental | Behavioral: Fact sheetmothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test |
| pre-test, control unrelated information | Placebo comparator | Behavioral: Fact sheetmothers do a pre-test, then read unrelated material, then repeat the test |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- new mothers with health full-term infants
- 5 minute Apgar 7 or more
Key exclusion criteria (3 listed)
- non-english speaking mothers
- mothers with psychiatric conditions
- infants admitted to intensive care unit
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 |
|---|---|---|
| Fact sheetfact sheet about pain management during immunization | Behavioural | control unrelated material, fact sheet review, pre-test, control unrelated information, pre-test, review of fact sheet |
Primary outcome
knowledge
Time frame: 10 minutes after intervention (educational material)
maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)
1 secondary outcome
utilization of pain relieving interventions
Time frame: 2 months after intervention
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.
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 Fact sheet in people with Mothers of Newborn Infants, 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 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. 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?
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?
knowledge (time frame: 10 minutes after intervention (educational material)). 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 30 Oct 2026.