PainNCT07044622
Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Insertion Pain
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Pain, run by Yale University at 2 sites in United States.
Trial summary
This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- 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
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2025to Dec 2026
- 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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- English-speaking individual aged 18 years or older.
- Presenting for IUD initiation or replacement during ambulatory care visits to the Yale Family Planning service and Center for Women's Health and Midwifery clinic.
- Opting for either LNG 52mg or copper T380A IUD.
- Review of the provider participant study Information Sheet and provision of verbal consent.
- IUD insertion performed by Yale Family Planning and Center for Women's Health and Midwifery clinic faculty and fellows, as well as OB/GYN residents on their family planning rotation, with IUD insertion competency.
- Performing an IUD insertion on a patient participant who meets all patient participant eligibility criteria
Who cannot join
- Contraindication to IUD initiation
- Current Pelvic Infection
- Distorted Uterine Anatomy (I.e., uterine septum, didelphys, uterine fibroids with cavity length greater than 12mm)
- Pregnancy
- Any other contraindications to IUD insertion as determined by the patient's clinical care staff.
- Exclusionary criteria for study participation
Show all 17Show fewer
- Current IUD with no visible strings
- Contraindication or allergy to ibuprofen
- History of chronic pain disorder
- Recent opioid use in the previous 30 days
- History of cardiac arrhythmia
- History of heart disease (i.e., atrial fibrillation, congestive heart failure)
- Presence of an implantable device with an electrical discharge (i.e., pacemaker)
- History of epilepsy
- BMI > 50
- History of TENS use
- Planned pain intervention outside standard of care OR pre-procedure use of non-standard pain medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Women's Health and Midwifery
New Haven, Connecticut, 06519
Yale Family Planning Clinic
New Haven, Connecticut, 06519
About this study
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Pain
This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.
Read the detailed description
The researchers will recruit eligible participants from patients who opt for IUD initiation or replacement during ambulatory care visits at the Center for Women's Health and Midwifery and Yale Family Planning Clinic. Allocation to treatment will be based on a 1:1 blocked randomization scheme. A member of the research/clinical staff other than the provider performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The research staff member will set up the TENS unit accordingly by applying pads to the participant and initiating treatment with the correct settings. When setup is complete, the provider performing the IUD insertion and other clinical staff assisting with the procedure will enter the exam room with no knowledge of TENS treatment assignment to insert the IUD.
REDCap, a HIPAA-compliant, secure web application used for building and managing online surveys and databases, will be used for data collection in this study. Participants will complete three electronic surveys in REDCap during the study. The first survey is a baseline survey to collect demographics as well as medical, obstetric, and gynecologic history and other characteristics prior to the IUD insertion procedure.
IUD insertion will be performed by complex family planning faculty and fellows, as well as OB/GYN residents on their family planning rotation. A research staff member will be within reach of the study participant during the procedure to collect pain scores using a visual analog scale (VAS) presented on an iPad.
The second survey will have a visual analog scale for study participants to rate their pain between 0 and 100 at the following timepoints during IUD insertion:
- Baseline
- Immediately after bimanual exam
- Immediately after speculum insertion
- If applicable, immediately after IUD removal
- Immediately after tenaculum placement
- Immediately after uterine sounding
- Immediately after IUD insertion
- 5 minutes after speculum removal
The third survey will ask participants about reflections on their experience with IUD insertion and acceptability of the TENS device, and their past experiences. Clinical Providers who perform the IUD insertion will be asked to take a post IUD insertion survey. This survey will ask questions about the insertion and perceived patient pain.
Participation in the study is expected to only last one day, the day of IUD insertion.
- Conditions
- Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- IUD, TENS
- Medical subject headings
- Pain
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
The TENS 7000 digital TENS unit is a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
The TENS 7000 digital TENS unit is a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| Placebo TENS | Placebo comparator | For the placebo TENS group, setup will be identical, but the device will not be turned on. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reported on Visual Analog Scale (VAS)
Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Measured: Day 1 (Day of IUD insertion)
Secondary outcomes (1)
Post Procedure Surveys
Identify factors other than exposure to TENS associated with higher reported pain, and the acceptability of the TENS device by both patients and providers. Questions answered as yes or no, or on a 4 to 5-point scale.
Measured: Day 1 (Day of IUD insertion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Null findings from similar study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Tessa Madden, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044622
- Sponsor's protocol ID
- 2000038467
- Status last verified
- Feb 2026
- First submitted
- 23 Jun 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data meta-analysis for this study will not be done. De-identified individual participant data will be analyzed according to the statistical plan mentioned in the study protocol for manuscript preparation and journal publication. Individual participant data will be shared within the study team. Also, IPD will be shared with the IRB according to institutional guidelines.
Publications
Gero A, Elliott S, Baayd J, Cohen S, Simmons RG, Gawron LM. Factors associated with a negative Patient Acceptable Symptom State (PASS) response with intrauterine device placement: A retrospective survey of HER Salt Lake participants. Contraception. 2024 May;133:110385. doi: 10.1016/j.contraception.2024.110385. Epub 2024 Feb 1.
PubMed 38307487Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26.
PubMed 31563628Wu J, Trahair E, Happ M, Swartz J. TikTok, #IUD, and User Experience With Intrauterine Devices Reported on Social Media. Obstet Gynecol. 2023 Jan 1;141(1):215-217. doi: 10.1097/AOG.0000000000005027. Epub 2022 Dec 5.
PubMed 36473194Svahn S, Niemeyer Hultstrand J, Tyden T, Ekstrand Ragnar M. Contraception use and attitudes: women's concerns regarding hormonal contraception and copper intrauterine devices. Eur J Contracept Reprod Health Care. 2021 Dec;26(6):473-478. doi: 10.1080/13625187.2021.1975267. Epub 2021 Sep 30.
PubMed 34590968Bracken J, Graham CA. Young women's attitudes towards, and experiences of, long-acting reversible contraceptives. Eur J Contracept Reprod Health Care. 2014 Aug;19(4):276-84. doi: 10.3109/13625187.2014.917623. Epub 2014 Jun 2.
PubMed 24882426Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.
PubMed 30095776Lohr PA, Lyus R, Prager S. Use of intrauterine devices in nulliparous women. Contraception. 2017 Jun;95(6):529-537. doi: 10.1016/j.contraception.2016.08.011. Epub 2016 Aug 31.
PubMed 27591814Pergialiotis V, Vlachos DG, Protopappas A, Vlachos GD. Analgesic options for placement of an intrauterine contraceptive: a meta-analysis. Eur J Contracept Reprod Health Care. 2014 Jun;19(3):149-60. doi: 10.3109/13625187.2014.903238. Epub 2014 May 14.
PubMed 24828514Shahnazi M, Nikjoo R, Yavarikia P, Mohammad-Alizadeh-Charandabi S. Inhaled lavender effect on anxiety and pain caused from intrauterine device insertion. J Caring Sci. 2012 Nov 28;1(4):255-61. doi: 10.5681/jcs.2012.035. eCollection 2012 Dec.
PubMed 25276703Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25.
PubMed 31882291Cimsir MT, Yildiz MS. Could the Valsalva manoeuvre be an alternative to the tenaculum for intrauterine device insertion? Eur J Contracept Reprod Health Care. 2021 Dec;26(6):503-506. doi: 10.1080/13625187.2021.1934442. Epub 2021 Jun 11.
PubMed 34114522Rahman M, King C, Saikaly R, Sosa M, Sibaja K, Tran B, Tran S, Morello P, Yeon Seo S, Yeon Seo Y, Jacobs RJ. Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. Cureus. 2024 Mar 8;16(3):e55785. doi: 10.7759/cureus.55785. eCollection 2024 Mar.
PubMed 38586685Gemzell-Danielsson K, Jensen JT, Monteiro I, Peers T, Rodriguez M, Di Spiezio Sardo A, Bahamondes L. Interventions for the prevention of pain associated with the placement of intrauterine contraceptives: An updated review. Acta Obstet Gynecol Scand. 2019 Dec;98(12):1500-1513. doi: 10.1111/aogs.13662. Epub 2019 Jun 27.
PubMed 31112295Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3.
PubMed 26222246Babazadeh-Zavieh SS, Bashardoust Tajali S, Haeri SMJ, Shamsi A. Effects of Transcutaneous Electrical Nerve Stimulation on Chronic Pelvic Pain in Women: A Systematic Review and Meta-Analysis. Complement Med Res. 2023;30(2):161-173. doi: 10.1159/000528133. Epub 2022 Nov 21.
PubMed 36412569
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Pain
- ClinicalTrials.gov ID
- NCT07044622
- Acronym / sponsor ID
- 2000038467
- Conditions
- Pain
- Keywords
- IUD, TENS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Null findings from similar study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- 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.
This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.
Detailed description
The researchers will recruit eligible participants from patients who opt for IUD initiation or replacement during ambulatory care visits at the Center for Women's Health and Midwifery and Yale Family Planning Clinic. Allocation to treatment will be based on a 1:1 blocked randomization scheme. A member of the research/clinical staff other than the provider performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The research staff member will set up the TENS unit accordingly by applying pads to the participant and initiating treatment with the correct settings. When setup is complete, the provider performing the IUD insertion and other clinical staff assisting with the procedure will enter the exam room with no knowledge of TENS treatment assignment to insert the IUD.
REDCap, a HIPAA-compliant, secure web application used for building and managing online surveys and databases, will be used for data collection in this study. Participants will complete three electronic surveys in REDCap during the study. The first survey is a baseline survey to collect demographics as well as medical, obstetric, and gynecologic history and other characteristics prior to the IUD insertion procedure.
IUD insertion will be performed by complex family planning faculty and fellows, as well as OB/GYN residents on their family planning rotation. A research staff member will be within reach of the study participant during the procedure to collect pain scores using a visual analog scale (VAS) presented on an iPad.
The second survey will have a visual analog scale for study participants to rate their pain between 0 and 100 at the following timepoints during IUD insertion:
- Baseline
- Immediately after bimanual exam
- Immediately after speculum insertion
- If applicable, immediately after IUD removal
- Immediately after tenaculum placement
- Immediately after uterine sounding
- Immediately after IUD insertion
- 5 minutes after speculum removal
The third survey will ask participants about reflections on their experience with IUD insertion and acceptability of the TENS device, and their past experiences. Clinical Providers who perform the IUD insertion will be asked to take a post IUD insertion survey. This survey will ask questions about the insertion and perceived patient pain.
Participation in the study is expected to only last one day, the day of IUD insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use. |
| Placebo TENS | Placebo comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)For the placebo TENS group, setup will be identical, but the device will not be turned on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- English-speaking individual aged 18 years or older.
- Presenting for IUD initiation or replacement during ambulatory care visits to the Yale Family Planning service and Center for Women's Health and Midwifery clinic.
- Opting for either LNG 52mg or copper T380A IUD.
Key exclusion criteria (17 listed)
- Contraindication to IUD initiation
- Current Pelvic Infection
- Distorted Uterine Anatomy (I.e., uterine septum, didelphys, uterine fibroids with cavity length greater than 12mm)
- Pregnancy
- Any other contraindications to IUD insertion as determined by the patient's clinical care staff.
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)The TENS 7000 digital TENS unit is a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction. | Device | Active TENS |
| Transcutaneous Electrical Nerve Stimulation (TENS)The TENS 7000 digital TENS unit is a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction. | Device | Placebo TENS |
Primary outcome
Pain reported on Visual Analog Scale (VAS)
Time frame: Day 1 (Day of IUD insertion)
Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
1 secondary outcome
Post Procedure Surveys
Time frame: Day 1 (Day of IUD insertion)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background: PubMed 38307487Gero A, Elliott S, Baayd J, Cohen S, Simmons RG, Gawron LM. Factors associated with a negative Patient Acceptable Symptom State (PASS) response with intrauterine device placement: A retrospective survey of HER Salt Lake participants. Contraception. 2024 May;133:110385. doi: 10.1016/j.contraception.2024.110385. Epub 2024 Feb 1.
- Background: PubMed 31563628Hunter TA, Sonalkar S, Schreiber CA, Perriera LK, Sammel MD, Akers AY. Anticipated Pain During Intrauterine Device Insertion. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):27-32. doi: 10.1016/j.jpag.2019.09.007. Epub 2019 Sep 26.
- Background: PubMed 36473194Wu J, Trahair E, Happ M, Swartz J. TikTok, #IUD, and User Experience With Intrauterine Devices Reported on Social Media. Obstet Gynecol. 2023 Jan 1;141(1):215-217. doi: 10.1097/AOG.0000000000005027. Epub 2022 Dec 5.
- Background: PubMed 34590968Svahn S, Niemeyer Hultstrand J, Tyden T, Ekstrand Ragnar M. Contraception use and attitudes: women's concerns regarding hormonal contraception and copper intrauterine devices. Eur J Contracept Reprod Health Care. 2021 Dec;26(6):473-478. doi: 10.1080/13625187.2021.1975267. Epub 2021 Sep 30.
- Background: PubMed 24882426Bracken J, Graham CA. Young women's attitudes towards, and experiences of, long-acting reversible contraceptives. Eur J Contracept Reprod Health Care. 2014 Aug;19(4):276-84. doi: 10.3109/13625187.2014.917623. Epub 2014 Jun 2.
- Background: PubMed 30095776Mody SK, Farala JP, Jimenez B, Nishikawa M, Ngo LL. Paracervical Block for Intrauterine Device Placement Among Nulliparous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Sep;132(3):575-582. doi: 10.1097/AOG.0000000000002790.
- Background: PubMed 27591814Lohr PA, Lyus R, Prager S. Use of intrauterine devices in nulliparous women. Contraception. 2017 Jun;95(6):529-537. doi: 10.1016/j.contraception.2016.08.011. Epub 2016 Aug 31.
- Background: PubMed 24828514Pergialiotis V, Vlachos DG, Protopappas A, Vlachos GD. Analgesic options for placement of an intrauterine contraceptive: a meta-analysis. Eur J Contracept Reprod Health Care. 2014 Jun;19(3):149-60. doi: 10.3109/13625187.2014.903238. Epub 2014 May 14.
- Background: PubMed 25276703Shahnazi M, Nikjoo R, Yavarikia P, Mohammad-Alizadeh-Charandabi S. Inhaled lavender effect on anxiety and pain caused from intrauterine device insertion. J Caring Sci. 2012 Nov 28;1(4):255-61. doi: 10.5681/jcs.2012.035. eCollection 2012 Dec.
- Background: PubMed 31882291Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25.
- Background: PubMed 34114522Cimsir MT, Yildiz MS. Could the Valsalva manoeuvre be an alternative to the tenaculum for intrauterine device insertion? Eur J Contracept Reprod Health Care. 2021 Dec;26(6):503-506. doi: 10.1080/13625187.2021.1934442. Epub 2021 Jun 11.
- Background: PubMed 38586685Rahman M, King C, Saikaly R, Sosa M, Sibaja K, Tran B, Tran S, Morello P, Yeon Seo S, Yeon Seo Y, Jacobs RJ. Differing Approaches to Pain Management for Intrauterine Device Insertion and Maintenance: A Scoping Review. Cureus. 2024 Mar 8;16(3):e55785. doi: 10.7759/cureus.55785. eCollection 2024 Mar.
- Long-Acting Reversible Contraception Implants and Intrauterine DevicesLink provided by the sponsor.
- Patient-Reported Outcomes Measurement Information System Global-10, PROMIS Global-10. APTALink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data meta-analysis for this study will not be done. De-identified individual participant data will be analyzed according to the statistical plan mentioned in the study protocol for manuscript preparation and journal publication. Individual participant data will be shared within the study team. Also, IPD will be shared with the IRB according to institutional guidelines.
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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.
Tessa Madden, MD, MPH principal investigator
Yale University
2 sites 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 Pain, run by Yale University at 2 sites 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 8 inclusion and 17 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: withdrawn, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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 reported on Visual Analog Scale (VAS) (time frame: Day 1 (Day of IUD insertion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07044622, which also lists 24 linked publications.
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 13 Feb 2026.