Optimal Method and Timing to Provide Information on Epidural and Spinal Anaesthesia for Primiparas
1 other identifier
interventional
280
0 countries
N/A
Brief Summary
Expectant mothers can give birth to their child either by vaginal delivery or by a caesarean section (the latter can be planned or necessary during an emergency). Among the pain-relieving options for vaginal delivery, they can choose to receive epidural analgesia. In case of a caesarean section, the three anaesthetic options are epidural, spinal, or general anaesthesia. The current Irish standard of care for the provision of information and consent for epidural and spinal anaesthesia entails a consultation with the anaesthesiologists at the request of the expectant mothers, shortly before the procedure. The uniformity of the information provided with this method is being debated. Moreover, there is a lack of consensus on the best timing and setting to informing patients. With the aim of standardising the provision of information on epidural and spinal anaesthesia, the Anaesthetic Department in Sligo University Hospital has created an informational video on such procedures, in which all benefits and possible complications are explained in detail. This video can be shown to expectant mothers at the antenatal classes or in the early stage of labour, as soon as they present to the labour ward. Importantly, this video is not aimed at promoting the use of the epidural catheter, rather at providing expectant mothers all the information on the technique, benefits, side effects and possible complications of the procedure. The main objective of this study is to evaluate whether this informational video is effective in improving patient confidence and satisfaction regarding these pain-relieving options, and what is the optimal timing to show the video. Our hypothesis is that, compared to the control group, women who watch the informational video will feel more confident in choosing to receive or not these pain-relieving options and therefore have a more positive childbirth experience. This study is a randomised control trial. Randomisation will produce 4 groups in total. Depending on the group allocation, participants may or may not be shown the informational video in relation to spinal/epidural anaesthesia at various stages (antenatal classes or at the time of their arrival on the labour ward). The control group will receive the usual Irish standard of care. After delivery, the patients will be interviewed with a questionnaire that will explore:
- Their satisfaction with the information provided in relation to the epidural/spinal anaesthesia;
- Their confidence in choosing to receive/not to receive these pain relieving options;
- Their ability to recollect the information provided on these pain-relieving options. To the extent of our knowledge, this is the first study that aims at improving parturients' sense of confidence and satisfaction in relation to the information provided on epidural and spinal anaesthesia. Should patients find this means of information beneficial to their care and overall experience, there is potential for nationwide distribution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
March 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2021
CompletedFebruary 25, 2020
February 1, 2020
1.3 years
February 20, 2020
February 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Patient satisfaction through survey questionnaire.
Women's satisfaction with the information received in relation to the epidural/spinal anaesthesia will be evaluated with a questionnaire developed with the help of a Consultant Psychiatrist. This questionnaire will be administered 48 hours after delivery.
48 hours after delivery
Secondary Outcomes (2)
Patient confidence through survey questionnaire.
48 hours after delivery
Patient recollection through survey questionnaire.
48 hours after delivery
Study Arms (4)
No Video
NO INTERVENTIONThese patients will not see the educational video on epidural/spinal analgesia and will receive the usual Irish standard of care.
Antenatal Video
EXPERIMENTALThese patients will see the educational video on epidural/spinal analgesia only at the antenatal classes.
Labour Video
EXPERIMENTALThese patients will see the educational video on epidural/spinal analgesia only at the beginning of labour.
Video Twice
EXPERIMENTALThese patients will see the educational video on epidural/spinal analgesia twice (during antenatal classes and at the beginning of labour).
Interventions
Ten-minutes educational video on epidural/spinal analgesia benefits and side effects (sample video link: https://youtu.be/jAhoKhvcbP4). The informational video will be administered by co-investigators, who are anaesthesiologists. The video will be shown on an institutional iPad that will be thoroughly disinfected by the co-investigators before and after each use. Co-investigators will receive training on the disinfection process, and each disinfection will be documented on a logbook, dated and signed by the co-investigators.
Eligibility Criteria
You may qualify if:
- Primiparas attending the labour ward in the early stage of labour
You may not qualify if:
- Patient refusal to participate
- Advanced phase of labour (as clinically assessed by midwives)
- Patient distress (as clinically assessed by midwives and anaesthesiologists)
- Intrauterine death
- Patients under 18 years of age
- Patients unable to provide consent
- Non-English speakers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 25, 2020
Study Start
March 2, 2020
Primary Completion
June 28, 2021
Study Completion
June 28, 2021
Last Updated
February 25, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share