Endometrial Diseases, Pain, Postoperative
Conditions
Keywords
endometrial biopsy, transcutaneous electrical nerve stimulation
Brief summary
The purpose of this study is to see whether transcutaneous electrical nerve stimulation (or TENS) reduces pain during an endometrial biopsy. A TENS unit is an over-the-counter, FDA approved device that sends low-level electrical impulses through the skin to reduce the amount of discomfort experienced during procedures. A TENS unit is very low-risk and used in a lot of ways, including for chronic pain, after surgery, and during labor. Since there is no standard way of managing discomfort during an endometrial biopsy, the investigators think that TENS might be helpful. Participating in the study may require some additional time in clinic to answer research-related questions. Subjects will be asked to answer demographic questions (which will be combined anonymously) before and after the procedure, as well as rate subject's pain at different time points during the procedure. The biggest benefit in participating is that subject's discomfort might be lower during and after the procedure. Subjects may not benefit from participating in this study. There is a small risk of a skin reaction from wearing the TENS pads.
Interventions
DEVICETENS 7000
TENS device to be used in both the active and placebo groups
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The participant and the provider completing the endometrial biopsy will be blinded to what group (intervention or placebo) that the subject is in. The clinical research coordinator assisting with the study and placement of the TENS will not be blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 18 years old * undergoing an outpatient endometrial biopsy * Duke gynecological oncology clinics and general gynecology clinic
Exclusion criteria
* age younger than 18 years * unable to follow study instructions and/or independently adjust TENS settings * cutaneous damage at the TENS application site * pacemaker or automatic implanted cardiac defibrillator * inability to understand or declines to sign the informed consent form * previous personal experience using a TENS unit * concurrent procedure (ex. IUD placement at time of biopsy) * pregnant women (will be excluded as part of standard of care for endometrial evaluation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) | Immediately after endometrial biopsy | Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of the Intervention Acceptability Based on Survey Response | End of procedure | A 0 to 100 mm scale similar to VAS (visual analog scale) to assess acceptability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention. 0 - completely acceptable to 100 - not at all acceptable |
| Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS) | End of procedure | A 0 to 100 mm scale similar to VAS to assess tolerability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention. |
| Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy | Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain |
| Provider Satisfaction With the Procedure | End of procedure | A 0 to 100 mm scale similar to VAS (visual analog scale) to assess provider satisfaction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active TENS Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups | 68 |
| Placebo TENS Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups | 67 |
| Total | 135 |
Baseline characteristics
| Characteristic | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 57 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 16 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 51 Participants | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 23 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 12 Participants | 18 Participants |
| Race (NIH/OMB) White | 26 Participants | 27 Participants | 53 Participants |
| Region of Enrollment United States | 68 Participants | 67 Participants | 135 Participants |
| Sex: Female, Male Female | 68 Participants | 67 Participants | 135 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 74 |
| other Total, other adverse events | 0 / 75 | 1 / 74 |
| serious Total, serious adverse events | 0 / 75 | 1 / 74 |
Outcome results
Primary
Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Time frame: Immediately after endometrial biopsy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active TENS | Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) | 50 mm |
| Placebo TENS | Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) | 60 mm |
p-value: 0.039Wilcoxon (Mann-Whitney)
Secondary
Measure of the Intervention Acceptability Based on Survey Response
A 0 to 100 mm scale similar to VAS (visual analog scale) to assess acceptability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention. 0 - completely acceptable to 100 - not at all acceptable
Time frame: End of procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active TENS | Measure of the Intervention Acceptability Based on Survey Response | 0 mm |
| Placebo TENS | Measure of the Intervention Acceptability Based on Survey Response | 0 mm |
Secondary
Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Time frame: Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Active TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | Speculum Placement | 20 mm |
| Active TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | Tenaculum Placement | 50 mm |
| Active TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | 5 min post biopsy | 10 mm |
| Active TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | 15 min post biopsy | 7.5 mm |
| Placebo TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | 15 min post biopsy | 10 mm |
| Placebo TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | Speculum Placement | 10 mm |
| Placebo TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | 5 min post biopsy | 20 mm |
| Placebo TENS | Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals | Tenaculum Placement | 55 mm |
Secondary
Provider Satisfaction With the Procedure
A 0 to 100 mm scale similar to VAS (visual analog scale) to assess provider satisfaction
Time frame: End of procedure
Population: Data not collected due to unavailability of providers post-procedure.
Secondary
Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)
A 0 to 100 mm scale similar to VAS to assess tolerability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention.
Time frame: End of procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active TENS | Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS) | 17.5 mm |
| Placebo TENS | Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS) | 30 mm |