Pain and Hysteroscopy

Hysteroscopy Surgery Clinical Trial

Official title:

Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316506
• Other study ID #: 20211092
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopy Surgery

Intervention

Other:
• Anticipated Discomfort Language
This language involves pain descriptors provided from physician to patient during procedure.
• Objective Descriptive Language
This language involves neutral/objective descriptors provided from physician to patients during procedure.

Locations

Country	Name	City	State
United States	University of Miami Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain as measured by Visual Analog Scale (VAS)	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).	Baseline (pre-procedure), Day 1 (post-procedure)
Secondary	Number of participants in each pain category	Number of participants reporting actual pain compared to their anticipated the pain post procedure.; Pain Free; Less painful than anticipated; As painful as anticipated; More painful than anticipated; Much more painful than anticipated	Day 1 (post-procedure)