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Pain and Hysteroscopy

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University of Miami

Status

Completed

Conditions

Hysteroscopy Surgery

Treatments

Other: Objective Descriptive Language
Other: Anticipated Discomfort Language

Study type

Interventional

Funder types

Other

Identifiers

NCT05316506
20211092

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Anticipated Discomfort Group
Other group
Description:
Participants will be prompted using anticipated discomfort language during the standard of care hysteroscopy.
Treatment:
Other: Anticipated Discomfort Language
Objective Description Group
Other group
Description:
Participants will be prompted using objective description language during the standard of care hysteroscopy.
Treatment:
Other: Objective Descriptive Language

Trial contacts and locations

1

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Central trial contact

Jaclyn Kwal, MD; Jose Carugno, MD

Data sourced from clinicaltrials.gov

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