A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Duke University
- Enrollment
- 66
- Primary Endpoint
- Pain With Tenaculum Placement
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Randomized controlled trial that compares methods of tenaculum placement during intrauterine device insertion and their effect on pain. The two methods being compared are slow tenaculum placement versus tenaculum placement at time of cough. Subjects will be asked to rate their pain using visual analog scale. Primary outcome measured is pain at time of tenaculum placement. Secondary outcomes are overall pain with intrauterine device insertion and provider satisfaction with tenaculum placement.
Detailed Description
The two commonly described strategies for tenaculum placement, slow versus having the patient cough while the tenaculum is placed are utilized by providers based on preference and/or their previous training. There is no published study that compares these methods to one another. The investigators aim to compare these strategies, slow tenaculum placement versus the cough method, and their effects on pain at time of placement. 96 subjects will be randomized to each method. The subject will be asked to rate their pain using a 100-mm visual analog scale after speculum placement, after tenaculum is placed, and after completion of the procedure. The provider will be asked to rate their satisfaction with tenaculum placement on a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected using REDCap database.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women ages 18 years and older
- •Undergoing intrauterine device placement
- •English or Spanish speaking
Exclusion Criteria
- •Primary language other than English or Spanish
Outcomes
Primary Outcomes
Pain With Tenaculum Placement
Time Frame: Directly after tenaculum placement
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Secondary Outcomes
- Overall Pain With Intrauterine Device Insertion(Directly after intrauterine device is placed)
- Provider Satisfaction With Tenaculum Placement(Directly after tenaculum is placed)