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AnxietyNCT06651320

Preoperative Animated Videos in Patients Undergoing Operative Hysteroscopy Under Anesthesia

A study testing 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 in people with Anxiety and Satisfaction with Care, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Anxiety, Satisfaction with Care
What is being tested?
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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIsrael
Study dates
1 Nov 2024to 28 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Neta Eisenberg Kogan, MD contact

+972 54 2573878

netaeis3@gmail.com

Israel1 site
  • Shamir Medical Center

    Tsrifin

    Neta Eisenberg Kogan, MD, +972 50 2573878, netaeis3@gmail.com

    Matan Mor, MD, +972 50 6462862, MatanMorMiz@gmail.com

Other trials in Israel

About this study

Official title: Effect of Preoperative Patient Education Via Animated Videos in Patients Undergoing Operative Hysteroscopy Under Anesthesia

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.

Read the 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.

Exclusion criteria: Patients who patient who are not able to watch the audiovisual video or who cannot sign a consent form.

The research would require a total 100 patients. The sample sign is based upon a previous study done in our institute assessing the effect of an audiovisual video on anxiety levels of patients undergoing diagnostic and operative hysteroscopy without anesthesia.

The patients would be randomly divided into the Intervention and Nonintervention group. Patients would be requested to fill up a questionnaire

  1. Intervention group: traditional patient education (nurse + physician pre-procedural counseling) + supplemental animation video describing the procedure itself and what to expect from it. This group will receive a code they ca scan so they can watch the video before entering the examination room where the physician will see them and where the hysteroscopy will be performed.
  2. The Nonintervention group would receive the traditional patient education before the procedure (via the team's nurse and the doctor performing the procedure) and would be unaware of the animation video in order to avoid bias in the questionnaire.

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).

For each patient the performing physician would fill up a basic demographic questionnaire (age, weight, obstetrical history, chronic diseases and medications) and after completing the procedure - information regarding the intrauterine findings and the procedure itself (actual finding, size and location of the finding, procedural length, instruments used, etc).

Anesthesia parameters during the operative hysteroscopy would also be measured including the patients' blood pressure, pulse and BIS and amount of anesthetic agents in order to assess the anesthesia.

In the context of anesthesia, PSI (Patient state Index) is a monitoring tool used to assess the depth of anesthesia in patients during surgery. It helps anesthesiologists ensure that a patient is neither too deeply nor too lightly anesthetized, aiming for an optimal balance. It uses sensors placed on the patient's forehead to measure electrical activity in the brain (EEG) and processes these signals and calculates a PSI value between 0-100. Score of 25-50 is the target range for general anesthesia, suggesting an adequate depth of anesthesia where the patient is unlikely to be conscious or aware. 50< may indicate a lighter plane of anesthesia where there is a risk of consciousness while 100 means fully awake and alert. By monitoring BIS, anesthesiologists can adjust the amount of anesthetic agents in real-time to maintain appropriate anesthesia levels, avoiding both under-dosing (which can lead to awareness) and over-dosing (which can cause prolonged recovery times or side effects). PSI is used alongside other clinical assessments and monitoring devices, such as heart rate and blood pressure, to guide anesthesia management.

Being tested
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
Keywords
hysteroscopy
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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, recoveryOther

    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).

Study groups in NCT06651320
Study groupRoleWhat they receive
1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) +Experimentalintervention
Receives: 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 (viNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (2)
  1. Heart rate (bpm)

    Measured: During the procedure, up to 120 minutes

  2. Blood pressure (mmHg)

    Measured: During the procedure, up to 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion28 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06651320
Sponsor's protocol ID
ASF-189-24
Status last verified
Oct 2024
First submitted
16 Oct 2024
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24732993
  • 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.

    PubMed 26283891

Questions about this trial

What is this clinical trial studying?

A study testing 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 in people with Anxiety and Satisfaction with Care, run by Assaf-Harofeh Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Neta Eisenberg Kogan, MD (+972 54 2573878, netaeis3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06651320, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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