IUD Insertion Pain
Conditions
Keywords
contraception
Brief 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. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.
Interventions
DEVICETranscutaneous 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.
DEVICEPlacebo 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.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* Contraindications to IUD placement * Use of analgesics within the last 4 hours prior to IUD placement * Presence of a pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain During IUD Insertion as Measured by the VAS Score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain During IUD Insertion as Measured by the VAS Score | speculum placement up to 1 minute | The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable |
| Pain Post IUD Insertion as Measured by the VAS Score | 5 minute post IUD insertion | The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJean M Marino, APRN-CNP
University Hospitals
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 8.9 |
| BMI | 29.4 kg/m^2 STANDARD_DEVIATION 8.4 |
| Chronic Pain Disease No | 21 Participants |
| Chronic Pain Disease Yes | 9 Participants |
| Dysmenorrhea Mild pain | 6 Participants |
| Dysmenorrhea Moderate pain | 17 Participants |
| Dysmenorrhea No pain | 7 Participants |
| Dysmenorrhea Severe pain | 7 Participants |
| Dysmenorrhea Worst pain imaginable | 5 Participants |
| Education Level Bachelors degree or higher | 19 participants |
| Education Level High school or equivalent | 20 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| History of Prior Pregnancy 0 Deliveries | 17 Participants |
| History of Prior Pregnancy 1 or more deliveries | 5 Participants |
| History of Vaginal Delivery No | 44 Participants |
| History of Vaginal Delivery Yes | 16 Participants |
| Marijuana Use Daily | 5 Participants |
| Marijuana Use Monthly | 2 Participants |
| Marijuana Use N/A - Age<21 | 2 Participants |
| Marijuana Use No use | 17 Participants |
| Marijuana Use Rarely | 6 Participants |
| Marijuana Use Weekly | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 |
| other Total, other adverse events | 0 / 26 | 0 / 27 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 |
Outcome results
None listed