Pain Perception With Tenaculum Placement
A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures
1 other identifier
interventional
66
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Jan 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2016
CompletedFirst Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2017
CompletedResults Posted
Study results publicly available
March 18, 2019
CompletedMarch 18, 2019
December 1, 2018
1.1 years
November 17, 2016
May 14, 2018
December 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Overall Pain With Intrauterine Device Insertion
Directly after intrauterine device is placed
Provider Satisfaction With Tenaculum Placement
Directly after tenaculum is placed
Study Arms (2)
Slow Tenaculum Placement
ACTIVE COMPARATORThis group will have their tenaculum placed using the slow method
Cough Method
ACTIVE COMPARATORThis group will have their tenaculum placed using the cough method
Interventions
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
Eligibility Criteria
You may qualify if:
- Women ages 18 years and older
- Undergoing intrauterine device placement
- English or Spanish speaking
You may not qualify if:
- Primary language other than English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Related Publications (1)
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.
PMID: 31666302DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Non-blinded study 2. No gold standard for pain analysis 3. Lack of accountability for confounder of anxiety/use of anxiolytics
Results Point of Contact
- Title
- Tashima Lambert, MD
- Organization
- Duke University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 21, 2016
Study Start
January 10, 2016
Primary Completion
February 23, 2017
Study Completion
February 23, 2017
Last Updated
March 18, 2019
Results First Posted
March 18, 2019
Record last verified: 2018-12