RCT of Pain Perception With Fast and Slow Tenaculum Application

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain, Acute Pain, Procedural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fast tenaculum application

Group Type EXPERIMENTAL

Speed of tenaculum application

Intervention Type PROCEDURE

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

Slow tenaculum application

Group Type EXPERIMENTAL

Speed of tenaculum application

Intervention Type PROCEDURE

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

Interventions

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Speed of tenaculum application

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. plans for IUD insertion or endometrial biopsy;
2. 18 to 49 years of age;
3. not taken analgesics or anxiolytics in the previous 24 hours;
4. the ability and are willing to give informed consent.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No