None listed
Conditions
Brief summary
We seek to determine whether the use of a multimedia video can enhance consent for patients undergoing a total laparoscopic hysterectomy. In the era of increasingly complex surgical procedures and focus on patient-centred decision-making, the responsibility on clinicians to provide quality informed consent has never been more critical. In the current surgical climate, the Coronavirus pandemic has meant less face-to-face appointments and further delays from the initial booking appointment to surgery. Various media sources are often informally accessed by patients but these risk misinformation and further confusion. The addition of multimedia videos to routine consent has been shown to increase patient understanding and recall which optimizes informed consent and healthcare outcomes. This is a randomised controlled trial. Participants will be patients currently on the waitlist for a total laparoscopic hysterectomy at the Mercy Hospital for Women who have already received routine consent with their doctor. Participants will be assessed on their baseline understanding of the procedure, baseline anxiety levels and health literacy. They will be randomised into two groups. Group 1 will receive additional routine verbal consent. Group 2 will receive additional routine verbal consent and then watch an 11 minute multimedia video. Both groups will complete a questionnaire afterwards to evaluate their understanding of their procedure, anxiety and satisfaction levels which is repeated at 4 weeks. The multimedia video uses animations and text to describe the procedure of a total laparoscopic hysterectomy as well as complications and post-operative recovery. Our hypothesis is that patients who watch the multimedia video will have a better understanding of their procedure which will be reflected in a higher score in the questionnaire, without a negative impact on their anxiety level.
Interventions
The interventional group will receive routine consent and then watch a supplementary multimedia video describing their planned surgery which is the exposure.
Routine consent involves verbal consent with the surgeon or senior member of the research team, as usually performed when waitlisted for surgery, to describe indications for surgery and associated complications. It will take 5-10 minutes and be performed at recruitment.
The multimedia video will be delivered immediately after routine co
The interventional group will receive routine consent and then watch a supplementary multimedia video describing their planned surgery which is the exposure. Routine consent involves verbal consent with the surgeon or senior member of the research team, as usually performed when waitlisted for surgery, to describe indications for surgery and associated complications. It will take 5-10 minutes and be performed at recruitment. The multimedia video will be delivered immediately after routine consent. The video is an 11 minute video which uses animations to depict and describe the relevant anatomy and indications for surgery, an explanation of the surgery, and the post-operative recovery. The video was not designed specifically for this study and is available for The Australasian Gynaecological Endoscopy and Surgery (AGES) Society members on the AGES website only. It is not available currently to the general public. There is one multimedia video for total laparoscopic hysterectomy and one for total laparoscopy hysterectomy with bilateral salpingo-oophrectomy. This will delivered via email link which will self-destruct. Given the delays to surgery with the current global pandemic and ever-changing directions to the elective surgery waitlist in Victoria, Australia it will not be possible to know when this exposure will be in relation to the actual surgery. The trial is designed to assess change in outcomes immediately after the exposure and at 4 weeks. A member of the research team will audit each participant to ensure consent forms are signed before proceeding to the next step of the study. We will use an automated program (REDCAPS) which allows for reminders to participants, and notifications to investigators until consent and questionnaires are completed. We will use email read receipts to check adherence to the intervention.
Sponsors
Avelyn Wong
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women requiring a total laparoscopic hysterectomy as determined and agreed to by both the surgeon and the participant. 2. Over 18 years of age at time of surgery. 3. Participants who understand the conditions of the study and are willing to participate for the duration of study including all follow-up. 4. Participants who are capable of, and have given, informed consent to their participation in the study. 5. Participants must have sufficient English reading and writing comprehension to complete the questionnaires
Exclusion criteria
1. Hysterectomy for malignant indications or under the gynae-oncology team
Outcome results
None listed