Preoperative Animated Videos in Patients Undergoing Operative Hysteroscopy Under Anesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssaf-Harofeh Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (above 18 and older),
Patients undergoing operative hysteroscopy under anesthesia in our OR due to uterine findings previously diagnosed during diagnostic hysteroscopy.
Disqualifiers
Patients who are not able to watch the audiovisual video
Patients who cannot sign a consent form.
Trial design
Design model
Parallel
Treatments tested in this trial
The patients in the interventional arm will be introduced to video will be introduced to a concise, animated video explaining the steps they are about to undergo in the department, the OR, recovery
Other interventionThe patients in the interventional arm will be introduced to video will be introduced to a concise, animated video explaining the steps they are about to undergo in the department, the OR, recovery and discharge. How to prepare for the procedure, what to expect during and after the procedure and what are the possible follow up scenarios. In order to overcome language berries videos would be available in basic 6th grader language and translated into English, Arabic and Russian for the non-Hebrew speaking population. There would be one staff member aware of the patient's allocation the international Vs nonintervention arm while the rest of the staff would be masked to the research arm the patient was allocated to. Once they have watched the video they would be asked to fill up a questionnaire their anxiety level concerning the procedure (STAI-S).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: 1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) +Experimental treatment 1 intervention
Group B: 2 The Nonintervention group would receive the traditional patient education before the procedure (viNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 hoursSecondary outcomes
1
Heart rate (bpm)
Time frame
During the procedure, up to 120 minutes2
Blood pressure (mmHg)
Time frame
During the procedure, up to 120 minutesSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: