A randomised controlled trial evaluating the effect of a multimedia video on informed consent in patients undergoing total laparoscopic hysterectomy

Not Applicable

Completed

• Conditions: Informed consent; Total laparoscopic hysterectomy; Surgery - Other surgery; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12621001496808
• Lead Sponsor: Avelyn Wong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-04
• Study Completion: 2023-12-29
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
knowledge scores in a questionnaire regarding the surgery . <br><br>This questionnaire has not been validated and was designed by the researchers specifically for this study, It has 15 questions and asks questions about the nature of the surgery, complications of the surgery and post-operative care after surgery.[ Baseline, immediately after intervention (primary endpoint) and 4 weeks post-intervention]

Secondary Outcome Measures

Name	Time	Method
Anxiety scores in the State-Trait Anxiety Inventory (STAI) survey which is a well-validated and commonly used measure of anxiety. It was not developed specifically for this study. [ baseline, immediately after intervention and 4 weeks after intervention. ];patient satisfaction questionnaire which is a 3 question dichotomous survey [ immediately after intervention and 4 weeks after intervention]