Abortion in First TrimesterNCT03187002
Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion
A study testing Transcutaneous electrical nerve stimulation (TENS) and Moderate IV Sedation in people with Abortion in First Trimester, run by Stanford University at 1 site in United States.
Trial summary
High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion in First Trimester
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS) and Moderate IV Sedation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting for surgical abortion
- Gestational age <12 weeks
- < 18 years of age
- Agrees to be randomized
Who cannot join
- Allergy to study medications (lidocaine, fentanyl, midazolam)
- > 18 years of age
- Fetal demise
- Pre-procedure use of misoprostol
- No means of transportation following procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Mar Monte
San Jose, California, 95126
About this study
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial
High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.
- Conditions
- Abortion in First Trimester
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), Moderate IV Sedation, SHAM: Transcutaneous electrical nerve stimulation (TENS), SHAM: Moderate IV Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
Moderate IV SedationDrug
IV sedation with fentanyl and versed
SHAM: Transcutaneous electrical nerve stimulation (TENS)Other
Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
SHAM: Moderate IV SedationOther
Sham IV to ensure blinding
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Transcutaneous electrical nerve stimulation (TENS) Receives: Device: Transcutaneous electrical nerve stimulation (TENS); Other: SHAM: Moderate IV Sedation |
| Moderate IV Sedation | Active comparator | Fentanyl, versed Receives: Drug: Moderate IV Sedation; Other: SHAM: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspiration Pain
Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Measured: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)
Secondary outcomes (6)
Speculum Placement Pain
Pain with speculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Measured: Intraoperative, collected during procedure (up to 30 seconds)
Tenaculum Placement Pain
Pain at time of tenaculum placement, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Measured: Intraoperative, collected during procedure (up to 30 seconds)
Paracervical Block Pain
Pain with paracervical block, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Measured: Intraoperative, collected during procedure (up to 30 seconds)
Manual Cervical Dilation Pain
Pain with manual cervical dilation, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Measured: Intraoperative, collected during procedure (up to 30 seconds)
Speculum Removal Pain
Pain with speculum removal, assessed by visual analog scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
Measured: Intraoperative, collected during procedure (up to 30 seconds)
Total Procedure Time
Time from speculum placement to speculum removal, measured in minutes
Measured: Intraoperative, collected during procedure (up to 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start18 Jan 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion in First TrimesterStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187002
- Sponsor's protocol ID
- IRB-41589
- Status last verified
- Oct 2020
- First submitted
- 9 Jun 2017
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.
PubMed 34352845
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During First Trimester Abortion: A Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03187002
- Acronym / sponsor ID
- IRB-41589
- Conditions
- Abortion in First Trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-frequency, high-intensity transcutaneous electrical nerve-stimulation (TENS) is an inexpensive and non-invasive pain control approach. TENS, pulsating electrical currents that activate underlying nerves, does not have drug interactions or risk of overdose. Cochrane review of TENS for acute pain found inconclusive evidence. One previous abortion trial comparing TENS to IV sedation only looked at pain control in the recovery room. The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first-trimester surgical abortion. Primary outcome will be perceived pain by Visual Analogue Scale (VAS) during aspiration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS), Other: SHAM: Moderate IV SedationTranscutaneous electrical nerve stimulation (TENS) |
| Moderate IV Sedation | Active comparator | Drug: Moderate IV Sedation, Other: SHAM: Transcutaneous electrical nerve stimulation (TENS)Fentanyl, versed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presenting for surgical abortion
- Gestational age <12 weeks
- < 18 years of age
- Agrees to be randomized
Key exclusion criteria (5 listed)
- Allergy to study medications (lidocaine, fentanyl, midazolam)
- > 18 years of age
- Fetal demise
- Pre-procedure use of misoprostol
- No means of transportation following procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS)Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders. | Device | Transcutaneous electrical nerve stimulation (TENS) |
| Moderate IV SedationIV sedation with fentanyl and versed | Drug | Moderate IV Sedation |
| SHAM: Transcutaneous electrical nerve stimulation (TENS)Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding | Other | Moderate IV Sedation |
| SHAM: Moderate IV SedationSham IV to ensure blinding | Other | Transcutaneous electrical nerve stimulation (TENS) |
Primary outcome
Aspiration Pain
Time frame: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)
Pain with aspiration, assessed by visual analogue scale (VAS, 0-100mm; 0 being "no pain" and 100 being "worst pain imaginable")
6 secondary outcomes
Speculum Placement Pain
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Tenaculum Placement Pain
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Paracervical Block Pain
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Manual Cervical Dilation Pain
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Speculum Removal Pain
Time frame: Intraoperative, collected during procedure (up to 30 seconds)
Total Procedure Time
Time frame: Intraoperative, collected during procedure (up to 20 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34352845Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Principal Investigator, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) and Moderate IV Sedation in people with Abortion in First Trimester, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aspiration Pain (time frame: Intraoperative, collected during procedure at the time of aspiration (up to 30 seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.