Preoperative Animated Videos in Patients Undergoing Operative Hysteroscopy Under Anesthesia

NCT06651320 | Not Yet Recruiting

• 1 other identifier: ASF-189-24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Satisfaction with Care

Keywords

hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Number of patients who experienced anxiety before the procedure as assessed by STAI-S

  From the enrollment to the beginning of general anesthesia, up to 48 hours

Secondary Outcomes (2)

• Heart rate (bpm)

  During the procedure, up to 120 minutes

• Blood pressure (mmHg)

  During the procedure, up to 120 minutes

Study Arms (2)

1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) +

EXPERIMENTAL

intervention

Other: 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

2 The Nonintervention group would receive the traditional patient education before the procedure (vi

NO INTERVENTION

Interventions

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

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 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).

1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) +

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (above 18 and older),
• Patients undergoing operative hysteroscopy under anesthesia in our OR due to uterine findings previously diagnosed during diagnostic hysteroscopy.

You may not qualify if:

• Patients who are not able to watch the audiovisual video
• Patients who cannot sign a consent form.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir Medical Center

Ẕerifin, Israel

Location

Related Publications (2)

• Ayyadhah Alanazi A. Reducing anxiety in preoperative patients: a systematic review. Br J Nurs. 2014 Apr 10-23;23(7):387-93. doi: 10.12968/bjon.2014.23.7.387.

  PMID: 24732993 BACKGROUND

• Gambadauro P, Navaratnarajah R, Carli V. Anxiety at outpatient hysteroscopy. Gynecol Surg. 2015;12(3):189-196. doi: 10.1007/s10397-015-0895-3. Epub 2015 May 13.

  PMID: 26283891 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Neta Eisenberg Kogan, MD

CONTACT

+972 54 2573878; netaeis3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician - Minimal Invasive Gynecology Unit, Shamir Medical Center

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

IL (1)