Skip to main content
OpenTrials
Completed

NCT Number: NCT05316506

Pain and Hysteroscopy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hysteroscopy Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Hospital

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Anticipated Discomfort Language

Other

This language involves pain descriptors provided from physician to patient during procedure.

Objective Descriptive Language

Other

This language involves neutral/objective descriptors provided from physician to patients during procedure.

Primary outcomes

  1. Change in Pain as measured by Visual Analog Scale (VAS)

    Time frame: 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 outcomes

  1. Number of participants in each pain category

    Time frame: Day 1 (post-procedure)

    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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.