Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529003
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
TENS Unit To Decrease Pain After Laminaria Insertion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial TENS Unit To Decrease Pain After Laminaria Insertion
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to learn more about the transcutaneous nerve stimulation TENS unit an over-the-counter option for pain relief that is not a medication The investigators are hoping to find out if this device decreases pain during and after laminaria placement for patients undergoing both elective and medically indicated second-trimester termination of pregnancy
Detailed Description:
To compare the maximum pain scores reported during the interval between osmotic dilator placement and DE procedure of patients receiving the standard of care plus sham placebo and those who use an adjunctive Transcutaneous electrical nerve stimulation TENS unit in addition to standard of care
Secondary objectives include comparing pain scores at the time of laminaria insertion assessing the number and duration of TENS sessions additional analgesic use satisfaction with pain management and patient perception of the ease of use of the TENS unit
Secondary objectives include comparing pain scores at the time of laminaria insertion assessing the number and duration of TENS sessions additional analgesic use satisfaction with pain management and patient perception of the ease of use of the TENS unit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None