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Optimal Method and Timing to Provide Information on Epidural and Spinal Anaesthesia for Primiparas

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ClinicalTrials.gov Identifier: NCT04283721
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Omar Tujjar, Sligo General Hospital

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.


Condition or disease Intervention/treatment Phase
Patient Satisfaction Confidence, Self Other: Educational video Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Optimal Method and Timing to Provide Information on Epidural and Spinal Anaesthesia for Primiparas: A Qualitative Randomised Control Trial
Estimated Study Start Date : March 2, 2020
Estimated Primary Completion Date : June 28, 2021
Estimated Study Completion Date : June 28, 2021

Arm Intervention/treatment
No Intervention: No Video
These patients will not see the educational video on epidural/spinal analgesia and will receive the usual Irish standard of care.
Experimental: Antenatal Video
These patients will see the educational video on epidural/spinal analgesia only at the antenatal classes.
Other: Educational video
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.

Experimental: Labour Video
These patients will see the educational video on epidural/spinal analgesia only at the beginning of labour.
Other: Educational video
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.

Experimental: Video Twice
These patients will see the educational video on epidural/spinal analgesia twice (during antenatal classes and at the beginning of labour).
Other: Educational video
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient confidence through survey questionnaire. [ Time Frame: 48 hours after delivery ]
    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.

  2. Patient recollection through survey questionnaire. [ Time Frame: 48 hours after delivery ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primiparas attending the labour ward in the early stage of labour

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283721


Contacts
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Contact: Omar Tujjar, Consultant ++353 071 9171111 omar.tujjar@hse.ie

Sponsors and Collaborators
Sligo General Hospital
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Responsible Party: Omar Tujjar, Principal Investigator, Sligo General Hospital
ClinicalTrials.gov Identifier: NCT04283721    
Other Study ID Numbers: 786
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No