IUD Insertion ComplicationNCT02716636
Fast Versus Slow Tenaculum Placement
A study testing Slow placement of the tenaculum in people with IUD Insertion Complication and Endometrial Diseases, run by Abbey Hardy-Fairbanks.
Trial summary
The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IUD Insertion Complication, Endometrial Diseases
- What is being tested?
- Slow placement of the tenaculum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- 11 Apr 2016to 6 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and older
- Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
- English speaking and able to consent
Who cannot join
- Incarcerated
- Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix
About this study
Official title: Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial
The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.
Read the detailed description
IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.
- Conditions
- IUD Insertion Complication, Endometrial Diseases
- Being tested
- Slow placement of the tenaculum
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow placement of the tenaculumProcedure or surgery
Slow placement of the tenaculum on the cervix
| Study group | Role | What they receive |
|---|---|---|
| Fast placement | No intervention | Placement of the tenaculum quickly and without avoiding ratchet |
| Slow placement of the tenaculum | Experimental | Placement of the tenaculum over a 7-10 second time frame and not allowing the tenaculum to ratchet audibly. Receives: Procedure: Slow placement of the tenaculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain with tenaculum placement assessed using a VAS scale
Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
Measured: procedure
Secondary outcomes (2)
Overall pain perception assessed using a VAS scale
Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
Measured: procedure
Provider perception of patient pain assessed using a VAS scale
Providers will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start11 Apr 2016
- Primary completion6 Mar 2017
- Study completion6 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUD Insertion ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbey Hardy-Fairbanks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abbey Hardy-Fairbanks, University of Iowa
- Investigators
- Abbey J Hardy-Fairbanks, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716636
- Sponsor's protocol ID
- 201509756
- Status last verified
- Mar 2018
- First submitted
- 17 Nov 2015
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Versus Slow Tenaculum Placement for Office Procedures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02716636
- Acronym / sponsor ID
- 201509756
- Conditions
- IUD Insertion Complication, Endometrial Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Abbey Hardy-FairbanksUniversity, hospital or other
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 6 Mar 2017 (actual)
- Study completion
- 6 Mar 2017 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.
Detailed description
IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast placement | No intervention | –Placement of the tenaculum quickly and without avoiding ratchet |
| Slow placement of the tenaculum | Experimental | Procedure: Slow placement of the tenaculumPlacement of the tenaculum over a 7-10 second time frame and not allowing the tenaculum to ratchet audibly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and older
- Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
- English speaking and able to consent
Key exclusion criteria (2 listed)
- Incarcerated
- Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow placement of the tenaculumSlow placement of the tenaculum on the cervix | Procedure or surgery | Slow placement of the tenaculum |
Primary outcome
Pain with tenaculum placement assessed using a VAS scale
Time frame: procedure
Subjects will record their pain on a paper VAS scale at the time of the procedure only. This is the only data collection point for this measure.
2 secondary outcomes
Overall pain perception assessed using a VAS scale
Time frame: procedure
Provider perception of patient pain assessed using a VAS scale
Time frame: procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
Related trials for IUD Insertion Complication
Recruiting
Assessing Pain and Effectiveness of Carevix Device for IUD Insertions
IUD, Abnormal Uterine Bleeding
RecruitingObservational study
Timing of LNG-IUD Insertion and Ovarian Cyst Formation
Ovarian Cysts, Menstrual Cycle
Recruiting
TENS Unit for Analgesia During IUD Insertion
IUD, Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbey J Hardy-Fairbanks, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing Slow placement of the tenaculum in people with IUD Insertion Complication and Endometrial Diseases, run by Abbey Hardy-Fairbanks.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain with tenaculum placement assessed using a VAS scale (time frame: procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.