Patient SatisfactionNCT04283721
Optimal Method and Timing to Provide Information on Epidural and Spinal Anaesthesia for Primiparas
A study testing Educational video in people with Patient Satisfaction and Confidence, Self, run by Sligo General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patient Satisfaction, Confidence, Self
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2020to 28 Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primiparas attending the labour ward in the early stage of labour
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optimal Method and Timing to Provide Information on Epidural and Spinal Anaesthesia for Primiparas: A Qualitative Randomised Control Trial
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.
Read more
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.
- Conditions
- Patient Satisfaction, Confidence, Self
- Being tested
- Educational video
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No Video | No intervention | These patients will not see the educational video on epidural/spinal analgesia and will receive the usual Irish standard of care. |
| Antenatal Video | Experimental | These patients will see the educational video on epidural/spinal analgesia only at the antenatal classes. Receives: Other: Educational video |
| Labour Video | Experimental | These patients will see the educational video on epidural/spinal analgesia only at the beginning of labour. Receives: Other: Educational video |
| Video Twice | Experimental | These patients will see the educational video on epidural/spinal analgesia twice (during antenatal classes and at the beginning of labour). Receives: Other: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after delivery
Secondary outcomes (2)
Patient confidence through survey questionnaire.
Women's degree of confidence in choosing to receive or not to receive epidural/spinal as pain-relieving options will be evaluated with a questionnaire developed with the help of a Consultant Psychiatrist. This questionnaire will be administered 48 hours after delivery.
Measured: 48 hours after delivery
Patient recollection through survey questionnaire.
Women's degree of recollecting the information received on 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.
Measured: 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start2 Mar 2020 (estimated)
- Primary completion28 Jun 2021 (estimated)
- Study completion28 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sligo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Tujjar, Sligo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283721
- Sponsor's protocol ID
- 786
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- 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 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Method and Timing to Provide Information on Epidural and Spinal Anaesthesia for Primiparas: A Qualitative Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04283721
- Acronym / sponsor ID
- 786
- Conditions
- Patient Satisfaction, Confidence, Self
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Sligo General HospitalUniversity, hospital or other
- Study start
- 2 Mar 2020 (estimated)
- Primary completion
- 28 Jun 2021 (estimated)
- Study completion
- 28 Jun 2021 (estimated)
- First posted
- 25 Feb 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Video | No intervention | –These patients will not see the educational video on epidural/spinal analgesia and will receive the usual Irish standard of care. |
| Antenatal Video | Experimental | Other: Educational videoThese patients will see the educational video on epidural/spinal analgesia only at the antenatal classes. |
| Labour Video | Experimental | Other: Educational videoThese patients will see the educational video on epidural/spinal analgesia only at the beginning of labour. |
| Video Twice | Experimental | Other: Educational videoThese patients will see the educational video on epidural/spinal analgesia twice (during antenatal classes and at the beginning of labour). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primiparas attending the labour ward in the early stage of labour
Key exclusion criteria (7 listed)
- 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
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 videoTen-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. | Other | Antenatal Video, Labour Video, Video Twice |
Primary outcome
Patient satisfaction through survey questionnaire.
Time frame: 48 hours after delivery
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.
2 secondary outcomes
Patient confidence through survey questionnaire.
Time frame: 48 hours after delivery
Patient recollection through survey questionnaire.
Time frame: 48 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 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.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Patient Satisfaction and Confidence, Self, run by Sligo General Hospital.
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 7 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 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Omar Tujjar, Consultant (++353 071 9171111, omar.tujjar@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction through survey questionnaire. (time frame: 48 hours after delivery). 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 25 Feb 2020.