Effect of Preoperative Patient Education Via Animated Videos in Patients Undergoing Operative Hysteroscopy Under Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Number of patients who experienced anxiety before the procedure as assessed by STAI-S
Study Overview
Brief Summary
The goal of this clinical trial is to assess if the use of an audiovisual animated video, describing the gynecological procedure (hysteroscopy) the patient is about to undergo, will help to reduce the patient's level of anxiety, affect her anesthesia parameters and increase their overall satisfaction from the procedure.
Our hypothesis is that patient who will watch the video (intervention group) will experience less anxiety, will have lower heart rate and lower blood pressure during the procedure, and have overall more satisfaction with the procedure, compared to patients who will not watch the preoperative video (control group).
Patients will be asked to rate their anxiety level before the procedure and their satisfaction afterwards.
Detailed Description
Is has been questioned what the effectiveness of various modes of delivering preoperative education in reducing preoperative anxiety is and as a result pain and overall satisfaction of patients from surgical producers. It is known that women undergoing hysteroscopy suffer from significant levels of anxiety, with repercussions on pain perception, success rates and satisfaction (1). In the inpatient surgery setting, preoperative anxiety is commonly managed by means of pharmacological interventions such as the use of anxiolytics and sedatives. Communication and patient education have been proved as effective tools to reduce preoperative anxiety, and their role should be increasingly acknowledged, now that many patients are active consumers of unfiltered and largely unreliable information through the Internet.
One meta-analysis which included 14 interventional trials (1) concluded that preoperative education interventions are promising in reducing preoperative anxiety in patients scheduled for surgical procedures (1).
Objective To assess if the use of an audiovisual animated video describing the gynecological procedure (hysteroscopy) the patient is about to undergo will help to reduce the patient's level of anxiety, affect her anesthesia parameters and increase their overall satisfaction from the procedure.
Design A randomized control trial including the patients undergoing operative hysteroscopy under anesthesia in the operation room via the endoscopy unit's team, Shamir hospital, Israel.
Inclusion criteria: adult patients (above 18 and older), undergoing operative hysteroscopy under anesthesia in our OR due to uterine findings previously diagnosed during diagnostic hysteroscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (above 18 and older),
- •Patients undergoing operative hysteroscopy under anesthesia in our OR due to uterine findings previously diagnosed during diagnostic hysteroscopy.
Exclusion Criteria
- •Patients who are not able to watch the audiovisual video
- •Patients who cannot sign a consent form.
Outcomes
Primary Outcomes
Number of patients who experienced anxiety before the procedure as assessed by STAI-S
Time Frame: From the enrollment to the beginning of general anesthesia, up to 48 hours
Secondary Outcomes
- Heart rate (bpm)(During the procedure, up to 120 minutes)
- Blood pressure (mmHg)(During the procedure, up to 120 minutes)
Investigators
Matan Mor
Attending physician - Minimal Invasive Gynecology Unit, Shamir Medical Center
Assaf-Harofeh Medical Center