Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow Tenaculum Placement | Active Comparator | This group will have their tenaculum placed using the slow method |
|
| Cough Method | Active Comparator | This group will have their tenaculum placed using the cough method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cough method for placement of tenaculum | Other | The intervention in this arm is the placement of tenaculum via cough method |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Directly after tenaculum placement |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Directly after intrauterine device is placed |
| Provider Satisfaction With Tenaculum Placement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31666302 | Derived | Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. BMJ Sex Reprod Health. 2020 Apr;46(2):126-131. doi: 10.1136/bmjsrh-2019-200376. Epub 2019 Oct 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Cough Method |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Directly after tenaculum placement |
|
10 - 15 minutes of patient contact during and immediately after IUD insertion.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tashima Lambert, MD | Duke University Medical Center | 484-201-9332 | dr.tlambert@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2016 | May 11, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Slow Tenaculum Placement of tenaculum | Other | The intervention in this arm is the placement of tenaculum via slow method |
|
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. |
| Directly after tenaculum is placed |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants with Parity >=1 | Count of Participants | Participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Directly after intrauterine device is placed |
|
|
|
| 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. | Posted | Count of Participants | Participants | Directly after tenaculum is placed |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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 | 0 | 33 | 0 | 33 | 0 | 33 |
Not provided
Not provided
Not provided