PainONesiENCT03099252
Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Implementation of Parent-targeted Education
An observational study of Pain, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
Newborn infants have blood work procedures for newborn screening and bilirubin testing in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Parent-targeted BSweet2Babies video
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to 30 Mar 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Ontario hospitals that provide Level 1 or Level 2 maternal/newborn care, contributing data to the BORN Information System and meet the eligibility criteria.
Who may be able to join
- Hospitals providing Level 1 and Level 2 maternal/newborn care contributing data to the BIS
- A birth volume of at least 50 per year
- Hospitals will be excluded if they:
- >85% use of pain management (BF, SSC, sucrose) during newborn screening
- >50% missing data for the pain management data element in the BIS. element.
- two hospitals that were used as pilot sites will be excluded
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Implementation of Parent-targeted Education (ONesiE)
Newborn infants have blood work procedures for newborn screening and bilirubin testing in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively and safely reduce pain and distress in newborn infants during painful procedures. However, studies of neonatal pain management practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies. There is a clear need for developing and testing acceptable parent-targeted interventions, alongside health care provider (HCP)-targeted knowledge translation (KT) interventions, to support parents' involvement in comforting their infants during painful procedures. To address this knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during infant bloodwork and how parents can use and advocate for these pain management strategies.
This project addresses a knowledge to practice gap that is highly relevant to all babies and their families. Thus, this study has the potential to advance health care of all babies and contribute to the science of KT by evaluating the implementation of a parent-targeted and mediated KT strategy in diverse hospital settings.
Hospitals were eligible for inclusion if they (1) provide Level 1 or Level 2 maternal/newborn care contributing data to the Better Outcomes Registry \& Network Ontario (BORN) Information Systems (BIS); (2) have a birth volume of at least 50 per year; (3) have <85% use of pain management (BF,SSC, sucrose) during newborn screening or bilirubin sampling, as per BIS data; and (4) have < 50% missing data for the pain management data element in the BIS. Participating hospitals will receive a tablet and will offer all parents the 5 minute BSweet2Babies video before newborn bloodwork. BORN Information System (BIS) data will subsequently be analyzed to evaluate the use of BF, SSC and sweet solutions.
Read the detailed description
Background: Newborn infants have blood work procedures for newborn screening and bilirubin testing in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively and safely reduce pain and distress in newborn infants during painful procedures. However, studies of neonatal pain management practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies. There is a clear need for developing and testing acceptable parent-targeted interventions, alongside health care provider-targeted knowledge translation (KT) interventions, to support parents' involvement in comforting their infants during painful procedures. To address this knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during infant bloodwork and how parents can use and advocate for these pain management strategies.
Objectives: To conduct a process evaluation to understand during the 6-month intervention period; (1) to what extent did HCPs implement the BSweet2Babies video in their setting; (2) What were the barriers and facilitators encountered in implementing the BSweet2Babies video; (3) What were the barriers and facilitators encountered in implementing the evidence shown in the BSweet2babies video (i.e. breastfeeding, skin-to-skin care, sucrose).
Study design and methods: Sequential exploratory mixed methods study. The mixed methods implementation study includes process evaluation, exploration of facilitators and barriers to implementation of the video and uptake of the demonstrated recommended pain management of BF, SSC or sucrose during initial blood sampling by heel prick.
Data Analysis: Directed content analysis will be used to analyse the qualitative data (i.e. monthly phone calls and bi-monthly community of practice teleconferences). Interview data will be transcribed verbatim with consent. A deductive and inductive approach will be used to code the qualitative data with codes developed apriori based on the Theoretical Domains Framework. Any concepts that do not fit within the framework will be assigned a new code.
Process evaluation will be described and summarized according to the process evaluation of complex intervention guide.
BORN Ontario data analysts in consultation with CoI Taljaard will conduct analysis using descriptive statistics to compare characteristics of participating sites and births including unit type (Level 1 compared to Level 2), birth volume, infant sex, and parity. In addition, BIS pain data will be reported as baseline and following the 6- month implementation period.
- Conditions
- Pain
- Being tested
- Parent-targeted BSweet2Babies video
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-targeted BSweet2Babies videoOther
The video portrays three babies having blood tests while being i) BF, ii) held SSC with the mother, and iii) receiving sucrose. The calming effects of these strategies are powerfully portrayed. Voice-over in user-friendly language explains how parents can help their babies by partnering with clinicians to use these strategies. As per the definition of patient-targeted and mediated interventions, this video is: i) patient (parent)-targeted, as it actively engages parents to improve their knowledge, positively affect their experience (during newborn screening), change their behavior and their baby's outcomes; ii) patient-mediated, as the video enables parents to change health professional behavior.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled | Participating hospitals will offer the video to all parents on their MBU during the 6 month intervention period (using the preferred delivery methods of the hospital and the parents). The video will be available via multiple means to facilitate optimal parental exposure in diverse settings. This will ensure flexibility of the delivery of the intervention, based on preferences of the nominated nurse leaders and their HCP team, families and available resources.
All participating maternal/newborn centres will receive the following tools via the designated nurse unit leader of enrolled sites:
1. Parent-targeted BSweet2Babies video
2. Parent cards- Reminder for parents of video, with Quick Response (QR) code of the video
3. BSweet2Babies Poster-visual reminder for parents and HCP's on the enrolled units
4. Monthly support calls for the nursing leaders of the Mother Baby Units (MBU)
5. Bi-monthly community of practice teleconferences for the nursing leaders of the MBU Receives: Other: Parent-targeted BSweet2Babies video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Process Evaluation
Directed content analysis will be used to analyze data from monthly interview, bi-monthly teleconferences and end of intervention surveys
Measured: 7 months.
BORN BIS Pain Data
Number of effective pain treatment used during newborn screening.
Measured: Six months prior to study launch date.
BORN BIS Pain Data
Number of effective pain treatment used during newborn screening.
Measured: Six months following completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Sep 2018
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Child Health Support Unit (OCHSU), Better Outcomes Registry & Network Ontario, Dalhousie University, Ottawa Hospital Research Institute, University of Calgary, McGill University, The Hospital for Sick Children, Headwaters Health Care Centre, Champlain Maternal Newborn Regional Program, St Thomas Elgin General Hospital, Baby Friendly Hospital Initiative
- Responsible party
- Principal investigator, Denise Harrison, Children's Hospital of Eastern Ontario
- Investigators
- Denise Harrison, RN, PhD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099252
- Sponsor's protocol ID
- CHEO REB# 17/01CTO
- Acronym
- ONesiE
- Status last verified
- Jun 2020
- First submitted
- 28 Mar 2017
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Babies: A Study of Ontario Maternal-Newborn Hospitals on the Implementation of Parent-targeted Education (ONesiE)
- ClinicalTrials.gov ID
- NCT03099252
- Acronym / sponsor ID
- ONesiE / CHEO REB# 17/01CTO
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Ontario Child Health Support Unit (OCHSU), Better Outcomes Registry & Network Ontario, Dalhousie University, Ottawa Hospital Research Institute, University of Calgary, McGill University, The Hospital for Sick Children, Headwaters Health Care Centre, Champlain Maternal Newborn Regional Program, St Thomas Elgin General Hospital, Baby Friendly Hospital Initiative
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 4 Apr 2017 (actual)
- 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.
Newborn infants have blood work procedures for newborn screening and bilirubin testing in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively and safely reduce pain and distress in newborn infants during painful procedures. However, studies of neonatal pain management practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies. There is a clear need for developing and testing acceptable parent-targeted interventions, alongside health care provider (HCP)-targeted knowledge translation (KT) interventions, to support parents' involvement in comforting their infants during painful procedures. To address this knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during infant bloodwork and how parents can use and advocate for these pain management strategies.
This project addresses a knowledge to practice gap that is highly relevant to all babies and their families. Thus, this study has the potential to advance health care of all babies and contribute to the science of KT by evaluating the implementation of a parent-targeted and mediated KT strategy in diverse hospital settings.
Hospitals were eligible for inclusion if they (1) provide Level 1 or Level 2 maternal/newborn care contributing data to the Better Outcomes Registry \& Network Ontario (BORN) Information Systems (BIS); (2) have a birth volume of at least 50 per year; (3) have <85% use of pain management (BF,SSC, sucrose) during newborn screening or bilirubin sampling, as per BIS data; and (4) have < 50% missing data for the pain management data element in the BIS. Participating hospitals will receive a tablet and will offer all parents the 5 minute BSweet2Babies video before newborn bloodwork. BORN Information System (BIS) data will subsequently be analyzed to evaluate the use of BF, SSC and sweet solutions.
Detailed description
Background: Newborn infants have blood work procedures for newborn screening and bilirubin testing in their first days of life that cause pain, distress and physiological changes. Breastfeeding (BF), skin to skin care (SSC), or giving small amounts of sweet solutions (sucrose or glucose) with or without a pacifier, effectively and safely reduce pain and distress in newborn infants during painful procedures. However, studies of neonatal pain management practices in Ontario and throughout Canada demonstrate inconsistent use of these strategies. There is a clear need for developing and testing acceptable parent-targeted interventions, alongside health care provider-targeted knowledge translation (KT) interventions, to support parents' involvement in comforting their infants during painful procedures. To address this knowledge to action (KTA) gap, Denise Harrison's Be Sweet to Babies team developed the BSweet2Babies video, which demonstrates the effectiveness of BF, SSC, and sucrose during infant bloodwork and how parents can use and advocate for these pain management strategies.
Objectives: To conduct a process evaluation to understand during the 6-month intervention period; (1) to what extent did HCPs implement the BSweet2Babies video in their setting; (2) What were the barriers and facilitators encountered in implementing the BSweet2Babies video; (3) What were the barriers and facilitators encountered in implementing the evidence shown in the BSweet2babies video (i.e. breastfeeding, skin-to-skin care, sucrose).
Study design and methods: Sequential exploratory mixed methods study. The mixed methods implementation study includes process evaluation, exploration of facilitators and barriers to implementation of the video and uptake of the demonstrated recommended pain management of BF, SSC or sucrose during initial blood sampling by heel prick.
Data Analysis: Directed content analysis will be used to analyse the qualitative data (i.e. monthly phone calls and bi-monthly community of practice teleconferences). Interview data will be transcribed verbatim with consent. A deductive and inductive approach will be used to code the qualitative data with codes developed apriori based on the Theoretical Domains Framework. Any concepts that do not fit within the framework will be assigned a new code.
Process evaluation will be described and summarized according to the process evaluation of complex intervention guide.
BORN Ontario data analysts in consultation with CoI Taljaard will conduct analysis using descriptive statistics to compare characteristics of participating sites and births including unit type (Level 1 compared to Level 2), birth volume, infant sex, and parity. In addition, BIS pain data will be reported as baseline and following the 6- month implementation period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled | – | Other: Parent-targeted BSweet2Babies videoParticipating hospitals will offer the video to all parents on their MBU during the 6 month intervention period (using the preferred delivery methods of the hospital and the parents). The video will be available via multiple means to facilitate optimal parental exposure in diverse settings. This will ensure flexibility of the delivery of the intervention, based on preferences of the nominated nurse leaders and their HCP team, families and available resources. All participating maternal/newborn centres will receive the following tools via the designated nurse unit leader of enrolled sites: 1. Parent-targeted BSweet2Babies video 2. Parent cards- Reminder for parents of video, with Quick Response (QR) code of the video 3. BSweet2Babies Poster-visual reminder for parents and HCP's on the enrolled units 4. Monthly support calls for the nursing leaders of the Mother Baby Units (MBU) 5. Bi-monthly community of practice teleconferences for the nursing leaders of the MBU |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ontario hospitals that provide Level 1 or Level 2 maternal/newborn care, contributing data to the BORN Information System and meet the eligibility criteria.
Key inclusion criteria (6 listed)
- Hospitals providing Level 1 and Level 2 maternal/newborn care contributing data to the BIS
- A birth volume of at least 50 per year
- >85% use of pain management (BF, SSC, sucrose) during newborn screening
- >50% missing data for the pain management data element in the BIS. element.
- two hospitals that were used as pilot sites will be excluded
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Parent-targeted BSweet2Babies videoThe video portrays three babies having blood tests while being i) BF, ii) held SSC with the mother, and iii) receiving sucrose. The calming effects of these strategies are powerfully portrayed. Voice-over in user-friendly language explains how parents can help their babies by partnering with clinicians to use these strategies. As per the definition of patient-targeted and mediated interventions, this video is: i) patient (parent)-targeted, as it actively engages parents to improve their knowledge, positively affect their experience (during newborn screening), change their behavior and their baby's outcomes; ii) patient-mediated, as the video enables parents to change health professional behavior. | Other | Enrolled |
Primary outcome
Process Evaluation
Time frame: 7 months.
Directed content analysis will be used to analyze data from monthly interview, bi-monthly teleconferences and end of intervention surveys
BORN BIS Pain Data
Time frame: Six months prior to study launch date.
Number of effective pain treatment used during newborn screening.
BORN BIS Pain Data
Time frame: Six months following completion of the intervention.
Number of effective pain treatment used during newborn screening.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Denise Harrison, RN, PhD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Children's Hospital of Eastern Ontario 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 6 inclusion and 0 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 11 Jun 2020. 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.
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?
Process Evaluation (time frame: 7 months.). The study lists 3 primary outcomes in all. 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 11 Jun 2020.