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Pain Perception With Tenaculum Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02969421
Recruitment Status : Completed
First Posted : November 21, 2016
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Interventions Other: Cough method for placement of tenaculum
Other: Slow Tenaculum Placement of tenaculum
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Slow Tenaculum Placement Cough Method
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 33 33
Completed 33 33
Not Completed 0 0
Arm/Group Title Slow Tenaculum Placement Cough Method Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 66 participants
25
(21 to 31)
28
(18 to 42)
26
(22.2 to 31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
33
 100.0%
33
 100.0%
66
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Hispanic or Latino
7
  21.2%
6
  18.2%
13
  19.7%
Not Hispanic or Latino
26
  78.8%
27
  81.8%
53
  80.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  39.4%
9
  27.3%
22
  33.3%
White
13
  39.4%
19
  57.6%
32
  48.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
  21.2%
5
  15.2%
12
  18.2%
Number of Participants with Parity >=1  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
14
  42.4%
19
  57.6%
33
  50.0%
Body mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 33 participants 33 participants 66 participants
26.4
(23 to 36.5)
24.8
(22 to 38.1)
26.1
(22.2 to 37.6)
1.Primary Outcome
Title Pain With Tenaculum Placement
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Slow Tenaculum Placement Cough Method
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 33 33
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
44
(21 to 63)
32
(19 to 54)
2.Secondary Outcome
Title Overall Pain With Intrauterine Device Insertion
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Slow Tenaculum Placement Cough Method
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 33 33
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
62
(48 to 84)
54
(32 to 71)
3.Secondary Outcome
Title Provider Satisfaction With Tenaculum Placement
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Slow Tenaculum Placement Cough Method
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 33 33
Measure Type: Count of Participants
Unit of Measure: Participants
26
  78.8%
27
  81.8%
Time Frame 10 - 15 minutes of patient contact during and immediately after IUD insertion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Slow Tenaculum Placement Cough Method
Hide Arm/Group Description

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

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

All-Cause Mortality
Slow Tenaculum Placement Cough Method
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Hide Serious Adverse Events
Slow Tenaculum Placement Cough Method
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Slow Tenaculum Placement Cough Method
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
  1. Non-blinded study
  2. No gold standard for pain analysis
  3. Lack of accountability for confounder of anxiety/use of anxiolytics
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tashima Lambert, MD
Organization: Duke University Medical Center
Phone: 484-201-9332
EMail: dr.tlambert@gmail.com
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02969421    
Other Study ID Numbers: Pro00078232
First Submitted: November 17, 2016
First Posted: November 21, 2016
Results First Submitted: May 14, 2018
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019