AnxietyNCT06625567
The Effect of Preoperative Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
A study testing Animated video in people with Anxiety, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Office hysteroscopy is a gynecologic procedure performed to evaluate the uterine cavity. In the majority of cases, this procedure is performed without anesthesia. Previous studies found significant levels of anxiety in women undergoing this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Animated video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Feb 2023to 2 Sep 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) undergoing hysteroscopy without anesthesia in the hysteroscopy outpatient clinic.
Who cannot join
- Patients who are unable to understand or watch the audiovisual video
- Patients who are unable to understand or to complete the Hebrew questionnaires.
- Age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Patient Education Via Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
Office hysteroscopy is a gynecologic procedure performed to evaluate the uterine cavity. In the majority of cases, this procedure is performed without anesthesia.
Previous studies found significant levels of anxiety in women undergoing this procedure. In the current study, we will assess if the use of a preoperative audiovisual animated video describing will affect patient's anxiety and pain.
All patients will receive the standard education regarding the procedure from the physician. In the study group, in addition, an educational animated video will be shown. Subsequently, all patients will be asked to fill an anxiety assessment questionnaire in Hebrew (State-Trait Anxiety Inventory - State). After the procedure, patients will be asked about their pain level (VAS). Finally, patients in the study group will be asked to fill a short questionnaire regarding the educational video.
Read the detailed description
Backgroung: Office hysteroscopy is a gynecologic procedure performed to evaluate the uterine cavity in cases of various gynecologic problems and abnormal ultrasound findings (such as endometrial polyps, fibroids, abnormal uterine bleeding, and infertility). In the majority of cases, this procedure is performed without anesthesia using a small diameter (~3-4 mm) fibro-optic equipment and a minimally invasive "no-touch" vaginoscopic technique. Although this procedure is considered to be non-painful and well tolerated, previous studies found significant levels of anxiety in women undergoing hysteroscopy without anesthesia. Several non-pharmacologic approaches have been suggested with the aim of decreasing patients' anxiety. Among those, communication and patient's education appear to have a significant role. In the current study, we will assess the effect of an educational video describing the procedure on patients' anxiety before hysteroscopy without anesthesia, and compare it to the anxiety levels of patients who received the standard education.
Objective To assess if the use of a preoperative audiovisual animated video describing hysteroscopy without anesthesia will affect patient's anxiety and pain.
Design A prospective, non-blinded, randomized comparative study including patients undergoing hysteroscopy without anesthesia in the outpatient hysteroscopy clinic at Shamir (Assaf Harofe) medical center. In the control group, patients will receive the standard education regarding the procedure. In the study group, patients will also watch a short educational video.
Inclusion criteria:
Adult patients (≥18 years) undergoing hysteroscopy without anesthesia in the hysteroscopy outpatient clinic.
Exclusion criteria:
- Patients who are unable to understand or watch the audiovisual video
- Patients who are unable to understand or to complete the Hebrew questionnaires. The study will include a total of 200 patients. The patients will be randomly assigned to the study or to the control group according to the day of the procedure (i.e., on select pre-determined days all patients will be assigned either to the control group or to the study group).
All patients will receive the standard education regarding the procedure from the physician. In the study group, in addition, an educational animated video will be shown. Subsequently, all patients will be asked to fill an anxiety assessment questionnaire in Hebrew (State-Trait Anxiety Inventory - State) (Appendix 1). The hysteroscopy will be performed according to the routine clinical care. After the procedure, patients will be asked about their pain level (VAS). Finally, patients in the study group will be asked to fill a short questionnaire regarding the educational video (Appendix 2).
Demographic variable (age, body mass index, obstetrical history and gynecologic history) will be also collected.
- Conditions
- Anxiety
- Being tested
- Animated video
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated videoOther
Patients will watch an educational video describing the procedure before hysteroscopy without anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure. |
| Intervention group | Experimental | Patients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure and will also watch a short educational video. Receives: Other: Animated video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels before the procedure
Anxiety levels before the procedure will be assesses according to the State-Trait Anxiety Inventory - State questionnaire which is composed out of 20 questions. Scoring is 1-4 for each question and total score is calculated using a formula with a final score of under 30 indicating low anxiety, 31-45 moderate anxiety and 46 and above high level of anxeity . The hysteroscopy will be performed according to the routine clinical care.
Measured: Immediately before procedure
Secondary outcomes (1)
Pain levels after procedure
Pain levels measure by Visual Analogue Scale scored from 0-10 (0 indicating no pain and 10 the highest level of pain) after procedure is done
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start26 Feb 2023
- Primary completion28 Feb 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- A prospective, non-blinded, randomized comparative study including patients undergoing hysteroscopy without anesthesia in the outpatient hysteroscopy clinic at Shamir (Assaf Harofe) medical center. In the control group, patients will receive the standard education regarding the procedure. In the study group, patients will also watch a short educational video.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Neta Eisenberg Kogan, Assaf-Harofeh Medical Center
- Investigators
- Neta Eisenberg Kogan, Principal investigator, Shamir Assaf Harofeh medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625567
- Sponsor's protocol ID
- 11-23
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that is collected will be shared
Publications
Angioli R, De Cicco Nardone C, Plotti F, Cafa EV, Dugo N, Damiani P, Ricciardi R, Linciano F, Terranova C. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):454-9. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17.
PubMed 23962572Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.
PubMed 22387163Vitale SG, Caruso S, Ciebiera M, Torok P, Tesarik J, Vilos GA, Cholkeri-Singh A, Gulino FA, Kamath MS, Cianci A. Management of anxiety and pain perception in women undergoing office hysteroscopy: a systematic review. Arch Gynecol Obstet. 2020 Apr;301(4):885-894. doi: 10.1007/s00404-020-05460-2. Epub 2020 Mar 5.
PubMed 32140807Gambadauro 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 8 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 on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
- ClinicalTrials.gov ID
- NCT06625567
- Acronym / sponsor ID
- 11-23
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 26 Feb 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 3 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.
Office hysteroscopy is a gynecologic procedure performed to evaluate the uterine cavity. In the majority of cases, this procedure is performed without anesthesia.
Previous studies found significant levels of anxiety in women undergoing this procedure. In the current study, we will assess if the use of a preoperative audiovisual animated video describing will affect patient's anxiety and pain.
All patients will receive the standard education regarding the procedure from the physician. In the study group, in addition, an educational animated video will be shown. Subsequently, all patients will be asked to fill an anxiety assessment questionnaire in Hebrew (State-Trait Anxiety Inventory - State). After the procedure, patients will be asked about their pain level (VAS). Finally, patients in the study group will be asked to fill a short questionnaire regarding the educational video.
Detailed description
Backgroung: Office hysteroscopy is a gynecologic procedure performed to evaluate the uterine cavity in cases of various gynecologic problems and abnormal ultrasound findings (such as endometrial polyps, fibroids, abnormal uterine bleeding, and infertility). In the majority of cases, this procedure is performed without anesthesia using a small diameter (~3-4 mm) fibro-optic equipment and a minimally invasive "no-touch" vaginoscopic technique. Although this procedure is considered to be non-painful and well tolerated, previous studies found significant levels of anxiety in women undergoing hysteroscopy without anesthesia. Several non-pharmacologic approaches have been suggested with the aim of decreasing patients' anxiety. Among those, communication and patient's education appear to have a significant role. In the current study, we will assess the effect of an educational video describing the procedure on patients' anxiety before hysteroscopy without anesthesia, and compare it to the anxiety levels of patients who received the standard education.
Objective To assess if the use of a preoperative audiovisual animated video describing hysteroscopy without anesthesia will affect patient's anxiety and pain.
Design A prospective, non-blinded, randomized comparative study including patients undergoing hysteroscopy without anesthesia in the outpatient hysteroscopy clinic at Shamir (Assaf Harofe) medical center. In the control group, patients will receive the standard education regarding the procedure. In the study group, patients will also watch a short educational video.
Inclusion criteria:
Adult patients (≥18 years) undergoing hysteroscopy without anesthesia in the hysteroscopy outpatient clinic.
Exclusion criteria:
- Patients who are unable to understand or watch the audiovisual video
- Patients who are unable to understand or to complete the Hebrew questionnaires. The study will include a total of 200 patients. The patients will be randomly assigned to the study or to the control group according to the day of the procedure (i.e., on select pre-determined days all patients will be assigned either to the control group or to the study group).
All patients will receive the standard education regarding the procedure from the physician. In the study group, in addition, an educational animated video will be shown. Subsequently, all patients will be asked to fill an anxiety assessment questionnaire in Hebrew (State-Trait Anxiety Inventory - State) (Appendix 1). The hysteroscopy will be performed according to the routine clinical care. After the procedure, patients will be asked about their pain level (VAS). Finally, patients in the study group will be asked to fill a short questionnaire regarding the educational video (Appendix 2).
Demographic variable (age, body mass index, obstetrical history and gynecologic history) will be also collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, non-blinded, randomized comparative study including patients undergoing hysteroscopy without anesthesia in the outpatient hysteroscopy clinic at Shamir (Assaf Harofe) medical center. In the control group, patients will receive the standard education regarding the procedure. In the study group, patients will also watch a short educational video.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure. |
| Intervention group | Experimental | Other: Animated videoPatients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure and will also watch a short educational video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) undergoing hysteroscopy without anesthesia in the hysteroscopy outpatient clinic.
Key exclusion criteria (3 listed)
- Patients who are unable to understand or watch the audiovisual video
- Patients who are unable to understand or to complete the Hebrew questionnaires.
- Age < 18
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 |
|---|---|---|
| Animated videoPatients will watch an educational video describing the procedure before hysteroscopy without anesthesia | Other | Intervention group |
Primary outcome
Anxiety levels before the procedure
Time frame: Immediately before procedure
Anxiety levels before the procedure will be assesses according to the State-Trait Anxiety Inventory - State questionnaire which is composed out of 20 questions. Scoring is 1-4 for each question and total score is calculated using a formula with a final score of under 30 indicating low anxiety, 31-45 moderate anxiety and 46 and above high level of anxeity . The hysteroscopy will be performed according to the routine clinical care.
1 secondary outcome
Pain levels after procedure
Time frame: Immediately after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 23962572Angioli R, De Cicco Nardone C, Plotti F, Cafa EV, Dugo N, Damiani P, Ricciardi R, Linciano F, Terranova C. Use of music to reduce anxiety during office hysteroscopy: prospective randomized trial. J Minim Invasive Gynecol. 2014 May-Jun;21(3):454-9. doi: 10.1016/j.jmig.2013.07.020. Epub 2013 Aug 17.
- Results publication: PubMed 22387163Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.
- Results publication: PubMed 32140807Vitale SG, Caruso S, Ciebiera M, Torok P, Tesarik J, Vilos GA, Cholkeri-Singh A, Gulino FA, Kamath MS, Cianci A. Management of anxiety and pain perception in women undergoing office hysteroscopy: a systematic review. Arch Gynecol Obstet. 2020 Apr;301(4):885-894. doi: 10.1007/s00404-020-05460-2. Epub 2020 Mar 5.
- Results publication: 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: Yes. The data that is collected will be shared
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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.
Neta Eisenberg Kogan principal investigator
Shamir Assaf Harofeh medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animated video in people with Anxiety, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety levels before the procedure (time frame: Immediately before procedure). 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 NCT06625567, which also lists 4 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 8 Oct 2024.