Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625567
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
The Effect of Preoperative Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Preoperative Patient Education Via Animated Videos on Anxiety in Patients Undergoing Hysteroscopy Without Anesthesia
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 patients 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 patients 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 ie 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
Objective To assess if the use of a preoperative audiovisual animated video describing hysteroscopy without anesthesia will affect patients 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None