MedTrace Logo

Audio-recording of Consent for Anaesthesia for Elective Caesarean Section

NCT04238741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-01-23

No results posted yet for this study

Summary

Informed consent should be obtained from patients (with capacity) before treatment - including anaesthesia - is administered. If the consent process is inadequate, it may lead to poor decision-making and dissatisfaction, sometimes leading to complaints or legal claims. Obstetric practice is a high-risk area for medicolegal claims and accurate, reliable documentation of consent is therefore vital in this group.

The hypothesis is that audio-recording of consent discussions would provide a record of the discussion for the patient and healthcare staff to refer to later, to assist in understanding and potentially prevent dissatisfaction, complaints and claims; and may improve the consent process itself if both parties know that the discussion will be audio-recorded.

This project aims to establish the acceptability and feasibility of audio-recording of consent for elective caesarean section. The investigators will trial the concept by establishing audio-recording of consent for anaesthesia for elective caesarean section, and aim to investigate the views of patients at Chelsea and Westminster Hospital taking part.

The investigators aim to address the following research questions:

* what are the views of patients (and to a lesser extent, doctors) involved in audio-recording of consent discussions for anaesthesia for elective caesarean section regarding its acceptability and utility?
* what were the perceived concerns and/or practical obstacles to overcome in the trial of concept?

Conditions

  • Caesarean Section
  • Anesthesia

Interventions

OTHER

Audio-recording of consent for anaesthesia for elective caesarean section

Antenatal women will be invited to attend 5-15 days before their caesarean section for an anaesthetic consent discussion with audio-recording. Participants will complete a questionnaire immediately following the recorded discussion and again within the 48 hours following their surgery, to establish their views on the process of audio-recording of consent and the potential usefulness/acceptability of the audio-recording.

Sponsors & Collaborators

  • Chelsea and Westminster NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Steve Yentis · Chelsea and Westminster Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-25
Primary Completion
2019-01-29
Completion
2019-01-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238741 on ClinicalTrials.gov