Trial Outcomes & Findings for Pain Perception With Tenaculum Placement (NCT NCT02969421)
NCT ID: NCT02969421
Last Updated: 2019-03-18
Results Overview
Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Directly after tenaculum placement
Results posted on
2019-03-18
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Perception With Tenaculum Placement
Baseline characteristics by cohort
| Measure |
Slow Tenaculum Placement
n=33 Participants
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
|
Cough Method
n=33 Participants
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
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
28 years
n=7 Participants
|
26 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Number of Participants with Parity >=1
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Body mass index
|
26.4 kg/m^2
n=5 Participants
|
24.8 kg/m^2
n=7 Participants
|
26.1 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Directly after tenaculum placementMeasured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Outcome measures
| Measure |
Slow Tenaculum Placement
n=33 Participants
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
|
Cough Method
n=33 Participants
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
|
|---|---|---|
|
Pain With Tenaculum Placement
|
44 units on a scale
Interval 21.0 to 63.0
|
32 units on a scale
Interval 19.0 to 54.0
|
SECONDARY outcome
Timeframe: Directly after intrauterine device is placedMeasured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.
Outcome measures
| Measure |
Slow Tenaculum Placement
n=33 Participants
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
|
Cough Method
n=33 Participants
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
|
|---|---|---|
|
Overall Pain With Intrauterine Device Insertion
|
62 units on a scale
Interval 48.0 to 84.0
|
54 units on a scale
Interval 32.0 to 71.0
|
SECONDARY outcome
Timeframe: Directly after tenaculum is placedMeasured 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.
Outcome measures
| Measure |
Slow Tenaculum Placement
n=33 Participants
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
|
Cough Method
n=33 Participants
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
|
|---|---|---|
|
Provider Satisfaction With Tenaculum Placement
|
26 Participants
|
27 Participants
|
Adverse Events
Slow Tenaculum Placement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cough Method
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place