Transcutaneous Electrical Nerve Stimulation (TENS) for Intrauterine Device (IUD) Insertion Pain

Yale University

Status

Enrolling

Conditions

Pain

Treatments

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type

Interventional

Funder types

Other

Identifiers

NCT07044622

2000038467

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Patient Participants:

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.

Inclusion Criteria Provider Participants:

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

Exclusion Criteria Patient Participants:

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
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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups, including a placebo group

Active TENS

Active Comparator group

Description:

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.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Placebo TENS

Placebo Comparator group

Description:

For the placebo TENS group, setup will be identical, but the device will not be turned on.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)