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NCT Number: NCT05458037

RCT of Pain Perception With Fast and Slow Tenaculum Application

This project will be a randomized controlled trial (RCT) measuring pain perception with two different tenaculum placement techniques on the uterine cervix. A tenaculum is an instrument used to hold the cervix (the opening to the uterus or womb) in place. The trial will measure pain perception with a Visual Analog Scale (VAS) from 0 to 100 mm for two different tenaculum placement techniques, fast and slow closure on the uterine cervix. The main objective of this study is to determine if there is a difference in pain perception with fast compared to slow tenaculum placement techniques on the uterine cervix. We hypothesize that the slow technique will be perceived as less painful for subjects as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). Subsidiary objectives include describing overall pain levels during the procedure.

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Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location status: Recruiting

Location contact

Rebecca Allen

CONTACT

About this study

In order to detect a 15 mm difference on the VAS with two-sided 5% alpha and 80% power and a standard deviation of 33 mm (based on prior studies), a total of 71 subjects per group are required. We aim to recruit 75 subjects per arm in order to account for possible drop out.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • plans for IUD insertion or endometrial biopsy;
  • 18 to 49 years of age;
  • not taken analgesics or anxiolytics in the previous 24 hours;
  • the ability and are willing to give informed consent.

Exclusion criteria

  • Do not speak English unless interpreter present;
  • Taken any narcotic or opiate medication in the last 24 hours.
  • Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines.
  • Taken any anti-anxiety medication or drug in the last 24 hours.
  • Taken any NSAIDS or Tylenol in the last 12 hours.

Treatment and study plan

Speed of tenaculum application

Procedure

Fast or slow closure of the tenaculum for application to the uterine cervix

Primary outcomes

  1. Pain perception with tenaculum application

    Time frame: during procedure

    Pain scores will be determined using the Visual Analog Scale (VAS) from 0 to 100 mm.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Allen, MD

CONTACT

[email protected]

401-274-1122 ext. 2724

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

A Randomized Controlled Trial of Pain Perception With Fast and Slow Tenaculum Application to the Uterine Cervix

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2022
Registry last updated
May 3, 2024

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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