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Pain and Hysteroscopy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05316506
Enrollment
70
Registered
2022-04-07
Start date
2022-09-01
Completion date
2023-09-01
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy Surgery

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.

Interventions

OTHERAnticipated Discomfort Language

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

OTHERObjective Descriptive Language

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

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Number of participants in each pain categoryDay 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026