Analgesia, EpiduralNCT05355103
Effects of an Educational Tool on Knowledge and Risk Retention About Epidural Analgesia in Parturients.
A study testing Educational tool about epidural analgesia in people with Analgesia, Epidural, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The purpose of this study if to assess the basic knowledge of parturients about epidural analgesia, including an assessment of risks and benefits, but also risks associated with the procedure, and the impact of giving an informative document, in addition to usual consent counseling, on retention of risks. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Epidural
- What is being tested?
- Educational tool about epidural analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2021to Mar 2023
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant woman
- Age over 18 years old
- Had epidural analgesia during labour
Who cannot join
- Medical condition having influence on the risks of receiving epidural analgesia
- Insufficient understanding of french language
- Inability to provide medical consent
- Diagnosed and documented intellectual limitation
- Epidural anesthesia being converted to general anesthesia for a urgent cesarean section
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Marie-Chantal Dubois, MD, 819-346-1110 ext. 14403, Marie-Chantal-Dubois@USherbrooke.ca
About this study
Official title: Effects of an Educational Tool on Knowledge and Risk Retention About Epidural Analgesia in Parturients: a Prospective Before-and-after Study
The purpose of this study if to assess the basic knowledge of parturients about epidural analgesia, including an assessment of risks and benefits, but also risks associated with the procedure, and the impact of giving an informative document, in addition to usual consent counseling, on retention of risks.
A questionnaire was build by Delphi method by an expert panel in anesthesia. The questionnaire was answered on the first postpartum day by a group of patient that received the usual consent in the investigators's institution, including a standard explanation of risks and benefits at the moment they receive the epidural analgesia.
Read more
Parallel to the recruiting of the first group of patient receiving standard information and consent, an educational tool was build to provide informations relative to the epidural, including informations about the technique, the functioning of the epidural, the risks and benefits.
A second group of patient, who will received the educational tool antepartum at the time of admission to hospital for their delivery, will answer the same questionnaire on post-partum day 1. The results will then be compared to determine if the educational tool can improve the knowledge about epidural and so lead to a better consent about the epidural technique.
Comments about the educational tool and suggestions for improvement will also be collected.
Read the detailed description
Discussing the risk and benefits of an epidural to a laboring woman can be a difficult task. Obtaining consent for the procedure whilst the pain, the anxiety, and the necessity of acting fast because of an active labor are added to the overwhelming quantity of information a laboring woman receive is among the challenges anesthesiologist must face before doing an epidural. The validity of the consent of a labouring women has already been proven in several studies. Indeed, it has been shown by that pain, either mild or severe, has no impact on the retention of epidural risks that have been explained. However, there is a significant variability regarding risk disclosure within different practice settings, particularly with respect to the incidence of serious complications. In studies, knowledge about the epidural and retention of information given at the time of consent remains poor, but could be improved by a learning tool (e.g., video, explanatory leaflet)
At the investigators's institution, standardized risks are exposed to the patient during the epidural technique. The five risks mentioned are hypotension, lumbar pain, failure (10%), risk of dura mater puncture (1%) and post-puncture headache as well as severe nerve injury up to paralysis (1/200 000). These risks are checked off on the anesthesia sheet when discussed with the patient. Groupe "before" will be asked about recall of risk and information giving after standard consent counseling. Groupe "after" will be exposed to an informative document explaining the risk as soon as active labour was confirmed. Participants will also have usual consent information standardized by local practice.
On post-partum day 1, participants will be asked about the risks exposed at the moment of consent regarding epidural analgesia by means of a questionnaire. The questionnaire distributed to patients contains true and false statement about the epidural and they will be asked about the truth of information. No additional information about the epidural will be disclose to the patients during the questionnaire. Group "before" will also be asked questions about how they would like to receive information concerning epidural and group "after" will be asked about if they appreciate receiving an informative brochure.
The informative document will be created by the study team and sent to the anesthesia and obstetrics teams in at study team's hospital for pre-approval. The maternity nurses will be asked to give the document as soon as the patient will be admitted to the ward. Before being recruited, parturient will have to ensure that they had indeed read the document before receiving epidural analgesia.
The aim of this before-and-after study is to evaluate the impact of adding an information document available at the admission for active labour on improving the knowledge of patients receiving epidural anesthesia as well as its effectiveness on retention of the risks explained at the time of consent. In addition, one of the sub-objectives is to identify which factors influence risk retention in order to eventually better adapt our pre-epidural counseling.
- Conditions
- Analgesia, Epidural
- Being tested
- Educational tool about epidural analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational tool about epidural analgesiaOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Women having received epidural analgesia after a standard verbal consent provided by the anesthesiologist before doing the epidural technique, representing the standard of practice in our institution |
| Exposed group | Active comparator | Woman having received epidural analgesia after having received and read an educational tool at her admission to labour and delivery unit, in addition to the standard verbal consent. Receives: Other: Educational tool about epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge and risk retention about epidural analgesia
Assessment of knowledge and risk retention about epidural analgesia. A questionnaire was build using Delphi method by an expert panel composed of anesthesiologists and Obstetric anesthesiologists. The final score of this questionnaire is the measurement tool for the primary outcome and is a dependant variable.
- Score will be determined by the number of right answers a patient has on a scale of 0 to 12 (12 questions)
- A patient gets 1 point for every right answer
- The scale is based on the number of questions in the questionnaire and is not validated in the literature
Since the two groups are independent, a T-test will be used if the data are normal. If not, a Mann-Whitney test will be used.
Multivariates analysis by linear regression will be done for the variables above to consider possible confounding factors:
- Previous epidural analgesia
- Pain at the moment of the epidural technique
- Satisfaction about the information received about epidural analgesia
Measured: Post-partum day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Jun 2021
- Primary completionSep 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, EpiduralStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie-Chantal Dubois, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355103
- Sponsor's protocol ID
- 2021-3575: Epid_Consent
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Educational Tool on Knowledge and Risk Retention About Epidural Analgesia in Parturients: a Prospective Before-and-after Study
- ClinicalTrials.gov ID
- NCT05355103
- Acronym / sponsor ID
- 2021-3575: Epid_Consent
- Conditions
- Analgesia, Epidural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 2 May 2022 (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.
The purpose of this study if to assess the basic knowledge of parturients about epidural analgesia, including an assessment of risks and benefits, but also risks associated with the procedure, and the impact of giving an informative document, in addition to usual consent counseling, on retention of risks.
A questionnaire was build by Delphi method by an expert panel in anesthesia. The questionnaire was answered on the first postpartum day by a group of patient that received the usual consent in the investigators's institution, including a standard explanation of risks and benefits at the moment they receive the epidural analgesia.
Parallel to the recruiting of the first group of patient receiving standard information and consent, an educational tool was build to provide informations relative to the epidural, including informations about the technique, the functioning of the epidural, the risks and benefits.
A second group of patient, who will received the educational tool antepartum at the time of admission to hospital for their delivery, will answer the same questionnaire on post-partum day 1. The results will then be compared to determine if the educational tool can improve the knowledge about epidural and so lead to a better consent about the epidural technique.
Comments about the educational tool and suggestions for improvement will also be collected.
Detailed description
Discussing the risk and benefits of an epidural to a laboring woman can be a difficult task. Obtaining consent for the procedure whilst the pain, the anxiety, and the necessity of acting fast because of an active labor are added to the overwhelming quantity of information a laboring woman receive is among the challenges anesthesiologist must face before doing an epidural. The validity of the consent of a labouring women has already been proven in several studies. Indeed, it has been shown by that pain, either mild or severe, has no impact on the retention of epidural risks that have been explained. However, there is a significant variability regarding risk disclosure within different practice settings, particularly with respect to the incidence of serious complications. In studies, knowledge about the epidural and retention of information given at the time of consent remains poor, but could be improved by a learning tool (e.g., video, explanatory leaflet)
At the investigators's institution, standardized risks are exposed to the patient during the epidural technique. The five risks mentioned are hypotension, lumbar pain, failure (10%), risk of dura mater puncture (1%) and post-puncture headache as well as severe nerve injury up to paralysis (1/200 000). These risks are checked off on the anesthesia sheet when discussed with the patient. Groupe "before" will be asked about recall of risk and information giving after standard consent counseling. Groupe "after" will be exposed to an informative document explaining the risk as soon as active labour was confirmed. Participants will also have usual consent information standardized by local practice.
On post-partum day 1, participants will be asked about the risks exposed at the moment of consent regarding epidural analgesia by means of a questionnaire. The questionnaire distributed to patients contains true and false statement about the epidural and they will be asked about the truth of information. No additional information about the epidural will be disclose to the patients during the questionnaire. Group "before" will also be asked questions about how they would like to receive information concerning epidural and group "after" will be asked about if they appreciate receiving an informative brochure.
The informative document will be created by the study team and sent to the anesthesia and obstetrics teams in at study team's hospital for pre-approval. The maternity nurses will be asked to give the document as soon as the patient will be admitted to the ward. Before being recruited, parturient will have to ensure that they had indeed read the document before receiving epidural analgesia.
The aim of this before-and-after study is to evaluate the impact of adding an information document available at the admission for active labour on improving the knowledge of patients receiving epidural anesthesia as well as its effectiveness on retention of the risks explained at the time of consent. In addition, one of the sub-objectives is to identify which factors influence risk retention in order to eventually better adapt our pre-epidural counseling.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Women having received epidural analgesia after a standard verbal consent provided by the anesthesiologist before doing the epidural technique, representing the standard of practice in our institution |
| Exposed group | Active comparator | Other: Educational tool about epidural analgesiaWoman having received epidural analgesia after having received and read an educational tool at her admission to labour and delivery unit, in addition to the standard verbal consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant woman
- Age over 18 years old
- Had epidural analgesia during labour
Key exclusion criteria (6 listed)
- Medical condition having influence on the risks of receiving epidural analgesia
- Insufficient understanding of french language
- Inability to provide medical consent
- Diagnosed and documented intellectual limitation
- Epidural anesthesia being converted to general anesthesia for a urgent cesarean section
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 |
|---|---|---|
| Educational tool about epidural analgesiaSee arm description | Other | Exposed group |
Primary outcome
Knowledge and risk retention about epidural analgesia
Time frame: Post-partum day 1
Assessment of knowledge and risk retention about epidural analgesia. A questionnaire was build using Delphi method by an expert panel composed of anesthesiologists and Obstetric anesthesiologists. The final score of this questionnaire is the measurement tool for the primary outcome and is a dependant variable. * Score will be determined by the number of right answers a patient has on a scale of 0 to 12 (12 questions) * A patient gets 1 point for every right answer * The scale is based on the number of questions in the questionnaire and is not validated in the literature Since the two groups are independent, a T-test will be used if the data are normal. If not, a Mann-Whitney test will be used. Multivariates analysis by linear regression will be done for the variables above to consider possible confounding factors: * Previous epidural analgesia * Pain at the moment of the epidural technique * Satisfaction about the information received about epidural analgesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational tool about epidural analgesia in people with Analgesia, Epidural, run by Université de Sherbrooke 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 6 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 2 May 2022. 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?
Contact Marie-Chantal Dubois, MD (819-346-1110 ext. 14403, marie-chantal.dubois@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and risk retention about epidural analgesia (time frame: Post-partum day 1). 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 2 May 2022.