Pain and Hysteroscopy

September 25, 2023 updated by: Jose Carugno, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anticipated Discomfort Group
Participants will be prompted using anticipated discomfort language during the standard of care hysteroscopy.
Other: Anticipated Discomfort Language
This language involves pain descriptors provided from physician to patient during procedure.
Other: Objective Description Group
Participants will be prompted using objective description language during the standard of care hysteroscopy.
Other: Objective Descriptive Language
This language involves neutral/objective descriptors provided from physician to patients during procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (pre-procedure), Day 1 (post-procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

  1. Pain Free
  2. Less painful than anticipated
  3. As painful as anticipated
  4. More painful than anticipated
  5. Much more painful than anticipated
Day 1 (post-procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Jose Carugno, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20211092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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