The Effect of Preoperative Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia

Shamir Medical Center (Assaf-Harofeh)

Status: Completed

Conditions: Anxiety

Treatments: Other: Animated video

Study type: Interventional

Funder types: Other

Identifiers

NCT06625567

11-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

No Intervention group

Description:

Patients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure.

Intervention group

Experimental group

Description:

Patients undergoing hysteroscopy without anesthesia. Patients will receive the standard education regarding the procedure and will also watch a short educational video.

Treatment:

Other: Animated video