Pain and Hysteroscopy
Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
April 7, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedSeptember 26, 2023
September 1, 2023
1 year
March 30, 2022
September 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of participants in each pain category
Day 1 (post-procedure)
Study Arms (2)
Anticipated Discomfort Group
OTHERParticipants will be prompted using anticipated discomfort language during the standard of care hysteroscopy.
Objective Description Group
OTHERParticipants will be prompted using objective description language during the standard of care hysteroscopy.
Interventions
This language involves pain descriptors provided from physician to patient during procedure.
This language involves neutral/objective descriptors provided from physician to patients during procedure.
Eligibility Criteria
You may qualify if:
- Adults 18 years of age and older
- Scheduled for in office hysteroscopy
- Able to consent for the study in English or Spanish
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami Hospital
Miami, Florida, 33136, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Carugno, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Obstetrics and Gynecology Minimally Invasive Gynecology/Robotic Division Director.
Study Record Dates
First Submitted
March 30, 2022
First Posted
April 7, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
September 26, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share