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Completed

NCT Number: NCT02716636

Fast Versus Slow Tenaculum Placement

The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.

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Key information

Conditions

IUD Insertion Complication Endometrial Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years old and older
  • Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
  • English speaking and able to consent

Exclusion criteria

  • Incarcerated
  • Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix

Treatment and study plan

Slow placement of the tenaculum

Procedure

Slow placement of the tenaculum on the cervix

Primary outcomes

  1. Pain with tenaculum placement assessed using a VAS scale

    Time frame: procedure

    Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.

Secondary outcomes

  1. Overall pain perception assessed using a VAS scale

    Time frame: procedure

    Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.

  2. Provider perception of patient pain assessed using a VAS scale

    Time frame: procedure

    Providers will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.

Sponsors and collaborators

Lead sponsor

Abbey Hardy-Fairbanks

Other

Registry information

Official study title

Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2016
Registry last updated
Mar 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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