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

NCT06625567 | Completed

• 1 other identifier: 11-23
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately before procedure

Secondary Outcomes (1)

• Pain levels after procedure

  Immediately after procedure

Study Arms (2)

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.

Other: Animated video

Interventions

Animated video OTHER

Patients will watch an educational video describing the procedure before hysteroscopy without anesthesia

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) undergoing hysteroscopy without anesthesia in the hysteroscopy outpatient clinic.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir medical center

Rishon LeZiyyon, Israel

Location

Related Publications (4)

• 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.

  PMID: 23962572 RESULT

• 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.

  PMID: 22387163 RESULT

• 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.

  PMID: 32140807 RESULT

• 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.

  PMID: 26283891 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Neta Eisenberg Kogan

  Shamir Assaf Harofeh medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician in the gynecology endoscopy unit

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 3, 2024
• Study Start: February 26, 2023
• Primary Completion: February 28, 2024
• Study Completion: September 2, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will be shared onced sent to publication for unlimited time
• Access Criteria: The data will be published in suitable journals for that purpose

Locations

IL (1)