Clinical trial NCT06625567: The Effect of Preoperative Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
Official title: Effect of Preoperative Patient Education Via Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-10-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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. 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:

1. Patients who are unable to understand or watch the audiovisual video
2. 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.

Eligibility criteria: 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.
* Age \< 18

Primary outcomes:
measure: Anxiety levels before the procedure
timeFrame: Immediately before procedure
Secondary outcomes:
measure: Pain levels after procedure
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Rishon LeZion
country: Israel
facility: Shamir medical center
Study officials:
affiliation: Shamir Assaf Harofeh medical center
name: Neta Eisenberg Kogan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Carta 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.
citation: Vitale 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.
citation: 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.