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Pain and Hysteroscopy

Sponsor
University of Miami (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05316506
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Anticipated Discomfort Language
  • Other: Objective Descriptive Language
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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. Pain Free Less painful than anticipated As painful as anticipated More painful than anticipated Much more painful than anticipated

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Hospital Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jose Carugno, Associate Professor Obstetrics and Gynecology Minimally Invasive Gynecology/Robotic Division Director., University of Miami
ClinicalTrials.gov Identifier:
NCT05316506
Other Study ID Numbers:
  • 20211092
First Posted:
Apr 7, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 10, 2022