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Behavioural Intervention

TENS for Pain Control During First-Trimester Abortion (TENS 2 0 Trial)

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-operative, collected during procedure (up to 30 seconds)

Awards & highlights

TENS 2 0 Trial Summary

This trial is investigating whether transcutaneous electrical nerve stimulation (TENS) is an effective pain management technique for first-trimester procedural abortions, as an alternative to IV sedation.

Who is the study for?

This trial is for English or Spanish-speaking individuals, 18 years or older, who are less than 12 weeks pregnant and seeking a first-trimester aspiration abortion without sedation. It's not for those planning to use oral/IV sedation, with conditions unsuitable for office procedures, fetal demise, needing misoprostol before the procedure, or with contraindications to TENS (like having a pacemaker or epilepsy).Check my eligibility

What is being tested?

The study tests if Transcutaneous Electrical Nerve Stimulation (TENS), which sends electrical currents through the skin to reduce pain sensitivity, can effectively manage pain during first-trimester abortions compared to a sham treatment. Participants will be randomly assigned to either TENS or sham in this blinded superiority trial.See study design

What are the potential side effects?

While TENS is generally considered safe and non-invasive, potential side effects may include local skin irritation where the electrodes are placed and discomfort from the electrical current. There might also be muscle twitching during use.

TENS 2 0 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intra-operative, collected during procedure (up to 30 seconds)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intra-operative, collected during procedure (up to 30 seconds)

This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-operative, collected during procedure (up to 30 seconds) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain during cervical dilation

Secondary outcome measures

Pain during procedure

Time spent in recovery area

TENS 2 0 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Transcutaneous electrical nerve stimulation (TENS)Experimental Treatment1 Intervention

Prior to the procedure, the patient will have two sets of two self-adhesive electrodes placed parallel to the spinal cord at the T10-L1 and S2-S4 levels for TENS administration. For participants randomized to the experimental group, the non-blinded study coordinator will turn on the TENS unit 5 minutes prior to the procedure and monitor stimulating frequency level (80-100 Hz and pulse duration of 400 microseconds; intensity or frequency will be monitored to be administered to a non-painful level).

Group II: ShamPlacebo Group1 Intervention

For the participants randomized to sham, the same placement of electrodes will occur, but the unit will not be delivering electrical stimulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous electrical nerve stimulation (TENS)

2020

Completed Phase 3

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,333,980 Total Patients Enrolled

42 Trials studying Pain

5,306 Patients Enrolled for Pain

Media Library

Transcutaneous electrical nerve stimulation (TENS) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05320432 — N/A

Pain Research Study Groups: Sham, Transcutaneous electrical nerve stimulation (TENS)

Pain Clinical Trial 2023: Transcutaneous electrical nerve stimulation (TENS) Highlights & Side Effects. Trial Name: NCT05320432 — N/A

Transcutaneous electrical nerve stimulation (TENS) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05320432 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for this medical experiment?

"As indicated on clinicaltrials.gov, this study is not currently accepting applicants. Initially posted August 12th 2022 and last updated September 7th 2022, the trial has no current openings; however there are 348 other trials that require participants at this time."

Answered by AI