Pain and Hysteroscopy

Not Applicable

Completed

• Conditions: Hysteroscopy Surgery
• Interventions: Other: Objective Descriptive Language; Other: Anticipated Discomfort Language

• Registration Number: NCT05316506
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-07
• Study Start: 2022-09-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

1. Adults 18 years of age and older
2. Scheduled for in office hysteroscopy
3. Able to consent for the study in English or Spanish

Exclusion Criteria

1. Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions)
2. Previous in-office hysteroscopy
3. Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal
4. Minors, prisoners, or other members of vulnerable populations
5. Patients who cannot communicate in English or Spanish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Objective Description Group	Objective Descriptive Language	Participants will be prompted using objective description language during the standard of care hysteroscopy.
Anticipated Discomfort Group	Anticipated Discomfort Language	Participants will be prompted using anticipated discomfort language during the standard of care hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Change in Pain as measured by Visual Analog Scale (VAS)	Baseline (pre-procedure), Day 1 (post-procedure)	Pain will be assessed using the Visual Analog Scale (VAS). Visual Analog Scale (VAS) is score from 0 (no pain) to 10 (worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Number of participants in each pain category	Day 1 (post-procedure)	Number of participants reporting actual pain compared to their anticipated the pain post procedure.; 1. Pain Free; 2. Less painful than anticipated; 3. As painful as anticipated; 4. More painful than anticipated; 5. Much more painful than anticipated

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States