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.
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.
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
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
- 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.
- 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.
- Conditions
- Anxiety, Satisfaction with Care
- 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 group | Role | What they receive |
|---|---|---|
| 1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) + | Experimental | intervention 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 (vi | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Heart rate (bpm)
Measured: During the procedure, up to 120 minutes
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.
- First posted21 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Matan Mor, Assaf-Harofeh Medical Center
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 24732993Gambadauro 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Patient Education Via Animated Videos in Patients Undergoing Operative Hysteroscopy Under Anesthesia
- ClinicalTrials.gov ID
- NCT06651320
- Acronym / sponsor ID
- ASF-189-24
- Conditions
- Anxiety, Satisfaction with Care
- Keywords
- hysteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) + | Experimental | 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, recoveryintervention |
| 2 The Nonintervention group would receive the traditional patient education before the procedure (vi | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (above 18 and older),
- Patients undergoing operative hysteroscopy under anesthesia in our OR due to uterine findings previously diagnosed during diagnostic hysteroscopy.
Key exclusion criteria (2 listed)
- Patients who are not able to watch the audiovisual video
- Patients who cannot sign a consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, recoveryThe 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). | Other | 1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) + |
Primary outcome
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
2 secondary outcomes
Heart rate (bpm)
Time frame: During the procedure, up to 120 minutes
Blood pressure (mmHg)
Time frame: During the procedure, up to 120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Background: PubMed 24732993Ayyadhah 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.
- Background: PubMed 26283891Gambadauro 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.
- Individual participant dataSharing planned: Undecided
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.