An interventional study of Cough method for placement of tenaculum and Slow Tenaculum Placement of tenaculum in Pain, sponsored by Duke University. Completed. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-18.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
This group will have their tenaculum placed using the slow method
Other: Slow Tenaculum Placement of tenaculum
This group will have their tenaculum placed using the cough method
Other: Cough method for placement of tenaculum
The intervention in this arm is the placement of tenaculum via cough method
The intervention in this arm is the placement of tenaculum via slow method
Pain With Tenaculum Placement
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Time frame: Directly after tenaculum placement
Overall Pain With Intrauterine Device Insertion
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Time frame: Directly after intrauterine device is placed
Provider Satisfaction With Tenaculum Placement
Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.
Time frame: Directly after tenaculum is placed
| Milestone | Slow Tenaculum Placement | Cough Method |
|---|---|---|
| Started | 33 | 33 |
| Completed | 33 | 33 |
| Not completed | 0 | 0 |
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
| units on a scale | Slow Tenaculum Placement | Cough Method |
|---|---|---|
| Pain With Tenaculum Placement | 44 (21 to 63) | 32 (19 to 54) |
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
| units on a scale | Slow Tenaculum Placement | Cough Method |
|---|---|---|
| Overall Pain With Intrauterine Device Insertion | 62 (48 to 84) | 54 (32 to 71) |
Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.
| Participants | Slow Tenaculum Placement | Cough Method |
|---|---|---|
| Provider Satisfaction With Tenaculum Placement | 26 | 27 |
Collected over 10 - 15 minutes of patient contact during and immediately after IUD insertion.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Slow Tenaculum Placement | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Cough Method | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Slow Tenaculum Placement | Cough Method | Total |
|---|---|---|---|
| Median | 25 (21 to 31) | 28 (18 to 42) | 26 (22.2 to 31) |
| Sex: Female, Male(Participants) | Slow Tenaculum Placement | Cough Method | Total |
|---|---|---|---|
| Female | 33 | 33 | 66 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Slow Tenaculum Placement | Cough Method | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 6 | 13 |
| Not Hispanic or Latino | 26 | 27 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Slow Tenaculum Placement | Cough Method | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 9 | 22 |
| White | 13 | 19 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 5 | 12 |
| Number of Participants with Parity >=1(Participants) | Slow Tenaculum Placement | Cough Method | Total |
|---|---|---|---|
| Count of participants | 14 | 19 | 33 |
| Body mass index(kg/m^2) | Slow Tenaculum Placement | Cough Method | Total |
|---|---|---|---|
| Median | 26.4 (23 to 36.5) | 24.8 (22 to 38.1) | 26.1 (22.2 to 37.6) |
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