Pain
Conditions
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.
Interventions
OTHERCough method for placement of tenaculum
The intervention in this arm is the placement of tenaculum via cough method
OTHERSlow Tenaculum Placement of tenaculum
The intervention in this arm is the placement of tenaculum via slow method
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Tenaculum Placement | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Pain With Intrauterine Device Insertion | Directly after intrauterine device is placed | Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain. |
| Provider Satisfaction With Tenaculum Placement | Directly after tenaculum is placed | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Slow Tenaculum Placement This group will have their tenaculum placed using the slow method
Slow Tenaculum Placement of tenaculum: The intervention in this arm is the placement of tenaculum via slow method | 33 |
| Cough Method This group will have their tenaculum placed using the cough method
Cough method for placement of tenaculum: The intervention in this arm is the placement of tenaculum via cough method | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | Slow Tenaculum Placement | Total | Cough Method |
|---|---|---|---|
| Age, Continuous | 25 years | 26 years | 28 years |
| Body mass index | 26.4 kg/m^2 | 26.1 kg/m^2 | 24.8 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 53 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with Parity >=1 | 14 Participants | 33 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 22 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) White | 13 Participants | 32 Participants | 19 Participants |
| Sex: Female, Male Female | 33 Participants | 66 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Slow Tenaculum Placement | Pain With Tenaculum Placement | 44 units on a scale |
| Cough Method | Pain With Tenaculum Placement | 32 units on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Slow Tenaculum Placement | Overall Pain With Intrauterine Device Insertion | 62 units on a scale |
| Cough Method | Overall Pain With Intrauterine Device Insertion | 54 units on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Slow Tenaculum Placement | Provider Satisfaction With Tenaculum Placement | 26 Participants |
| Cough Method | Provider Satisfaction With Tenaculum Placement | 27 Participants |