IUD Insertion PainNCT06335823
Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with IUD Insertion Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IUD Insertion Pain
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2024to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years old
- Individuals with a cervix and uterus
- Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
- Meet medical eligibility for IUD placement
- Ability to consent in English
- Ability to use the visual analogue scale (VAS)
Who cannot join
- Contraindications to IUD placement
- Use of analgesics within the last 4 hours prior to IUD placement
- Presence of a pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.
- Conditions
- IUD Insertion Pain
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), Placebo Transcutaneous electrical nerve stimulation (TENS)
- Keywords
- contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Placebo Transcutaneous electrical nerve stimulation (TENS)Device
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS unit | Experimental | All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Non-active TENS unit | Placebo comparator | All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. Receives: Device: Placebo Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During IUD Insertion as Measured by the VAS Score
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Measured: IUD placement/introducer removal up to 5 minute
Secondary outcomes (4)
Pain During IUD Insertion as Measured by the VAS Score
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Measured: speculum placement up to 1 minute
Pain During IUD Insertion as Measured by the VAS Score
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Measured: tenaculum placement up to 1 minute
Pain During IUD Insertion as Measured by the VAS Score
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Measured: sound insertion up to 5 minute
Pain Post IUD Insertion as Measured by the VAS Score
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Measured: 5 minute post IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start5 Jun 2024
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IUD Insertion PainStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean M Marino, APRN-CNP, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335823
- Sponsor's protocol ID
- STUDY20231621
- Status last verified
- Feb 2026
- First submitted
- 21 Mar 2024
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled Study on the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
- ClinicalTrials.gov ID
- NCT06335823
- Acronym / sponsor ID
- STUDY20231621
- Conditions
- IUD Insertion Pain
- Keywords
- contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Posted 2 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS unit | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. |
| Non-active TENS unit | Placebo comparator | Device: Placebo Transcutaneous electrical nerve stimulation (TENS)All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45 years old
- Individuals with a cervix and uterus
- Seeking intrauterine device (IUD) placement for contraception or management of abnormal uterine bleeding
- Meet medical eligibility for IUD placement
- Ability to consent in English
Key exclusion criteria (3 listed)
- Contraindications to IUD placement
- Use of analgesics within the last 4 hours prior to IUD placement
- Presence of a pacemaker
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width. | Device | Active TENS unit |
| Placebo Transcutaneous electrical nerve stimulation (TENS)All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on. | Device | Non-active TENS unit |
Primary outcome
Pain During IUD Insertion as Measured by the VAS Score
Time frame: IUD placement/introducer removal up to 5 minute
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
4 secondary outcomes
Pain During IUD Insertion as Measured by the VAS Score
Time frame: speculum placement up to 1 minute
Pain During IUD Insertion as Measured by the VAS Score
Time frame: tenaculum placement up to 1 minute
Pain During IUD Insertion as Measured by the VAS Score
Time frame: sound insertion up to 5 minute
Pain Post IUD Insertion as Measured by the VAS Score
Time frame: 5 minute post IUD insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jean M Marino, APRN-CNP principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with IUD Insertion Pain, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 6 inclusion and 3 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 During IUD Insertion as Measured by the VAS Score (time frame: IUD placement/introducer removal up to 5 minute). 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 2 Mar 2026.