Pain
Conditions
Keywords
IUD, TENS
Brief 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. 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: 1. Baseline 2. Immediately after bimanual exam 3. Immediately after speculum insertion 4. If applicable, immediately after IUD removal 5. Immediately after tenaculum placement 6. Immediately after uterine sounding 7. Immediately after IUD insertion 8. 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.
Interventions
DEVICETranscutaneous 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.
Sponsors
Yale University
Society of Family Planning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reported on Visual Analog Scale (VAS) | Day 1 (Day of IUD insertion) | Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Procedure Surveys | Day 1 (Day of IUD insertion) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTessa Madden, MD, MPH
Yale University
Outcome results
None listed