Labor PainNCT04894539
Transcutaneous Electrical Nerve Stimulation for Labor Pain Control
A study testing DS5 electrical stimulator in people with Labor Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. Despite several years of research, there is still no agreement within the literature regarding the selection of TENS parameters. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- DS5 electrical stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2019to 6 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy
- Between ages 18-39 years
- Vertex presentation
- Speak, read and understand Danish
- At term (37-42 weeks gestation age)
Who cannot join
- High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension, and hypotension, intrauterine growth restriction, polyhydramnios, and oligohydramnios).
- Pre-gestational body mass index above 40 kg/m2
- Use of fetal-scalp electrode during the experiment
- Use of pacemakers and other electronic implants
- Severe arrhythmia
- Present musculoskeletal/neurological illnesses
Show all 14Show fewer
- Chronic pain within last 6 months
- Present medicated mental disorders
- Dermatological disorders
- Use of other long-acting pain relief
- Use of TENS 48 hours before the trial
- Drug addiction defines as the use of cannabis, opioids, or other drugs.
- Smokers
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electrical Nerve Stimulation as a Pain-relieving Approach in Labor Pain Control: a Randomized Double-blinded Controlled Pilot Study
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. Despite several years of research, there is still no agreement within the literature regarding the selection of TENS parameters. It is aimed to investigate two types of TENS frequencies (TENS1 alternating between 4 to 100 Hz and TENS2 alternating between 80 to 100 Hz) compared to sham-TENS.
Read the detailed description
Midwives and the study investigator will ask parturients, who are admitted to the labor ward at Region Hospital Herning satisfying the inclusion and exclusion criteria, whether they are interested in attending the experimental session.
The study will be conducted as soon as the subject is admitted at the labor ward. The study will only be conducted during early and active labor and not during the birth of the baby.
The subject in this study includes the package of a parturient and her neonate (after birth) as we also obtain data about the neonate. Hereby, two consent forms will be obtained. As this study is a non-invasive study, it is decided to have at least the consent of one parent.
The investigator will fill out a questionnaire about the parturient in cooperation with the subject and midwife, including screening questions related to inclusion and exclusion criteria before the experimental session starts.
The study will last approximately one hour and will be conducted during laboring circumstances. KT (Kenoja Thuvarakan) will carry out the experiment, and she will be present in the delivery room during the whole session.
The study includes several outcomes, including subjective and semi-objective pain measures. The primary outcome is VAS (0-10 cm scale), while secondary outcomes include PPT and satisfaction questionnaire (only at the end of the study). The subjects will be asked before, and immediately after the experimental exposure about the four outcomes (VAS and PPT). The subjects will be exposed to one of the two combinations of TENS stimulation (low and high alternating frequency), which will be compared to sham-TENS.
- Conditions
- Labor Pain
- Being tested
- DS5 electrical stimulator
- Keywords
- TENS, Labor pain, Childbirth, RCT, Pilot study
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS5 electrical stimulatorDevice
TENS
| Study group | Role | What they receive |
|---|---|---|
| TENS1 | Experimental | TENS with 4/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted. Receives: Device: DS5 electrical stimulator |
| TENS2 | Experimental | TENS with 80/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted. Receives: Device: DS5 electrical stimulator |
| Sham-TENS | Sham comparator | Sham with 100 Hz in frequency, 200 µs in pulse duration, and intensity below 5 mA. Receives: Device: DS5 electrical stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog scale (VAS)
10-cm pain intensity scale with 0 cm is no pain and 10 cm is unbearable pain. Decreased cm after baseline measurement indicates pain relief.
Measured: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
Change in Pain pressure threshold
Pain sensitivity measurement also defined as the minimum pressure needed to evoke a pain response measured in kPa. Increased kPa after baseline measurement indicates pain relief.
Measured: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
Secondary outcomes (4)
Satisfaction of TENS
Satisfaction rating on scale from 0 to 10 [0 as 'no satisfaction' and 10 as 'total satisfaction'].
Measured: Right after last measurements of VAS & PPT
Experienced pain reduction
Response to yes or no
Measured: Right after last measurements of VAS & PPT
Interest in the use of TENS again
Response to yes, no, or don't know
Measured: Right after last measurements of VAS & PPT
Recommend TENS to others
Response to yes, no, or don't know
Measured: Right after last measurements of VAS & PPT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start1 Aug 2019
- Primary completion5 Apr 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- Model description
- 3 groups (TENS1, TENS2, and sham)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Centaflow, Herning Hospital
- Responsible party
- Principal investigator, Kenoja Thuvarakan, Aalborg University
- Investigators
- Parisa Gazerani, PhD, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894539
- Sponsor's protocol ID
- 20190821
- Status last verified
- Jul 2021
- First submitted
- 13 May 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is described in Danish and therefore no plan of sharing.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation as a Pain-relieving Approach in Labor Pain Control: a Randomized Double-blinded Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04894539
- Acronym / sponsor ID
- 20190821
- Conditions
- Labor Pain
- Keywords
- TENS, Labor pain, Childbirth, RCT, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Centaflow, Herning Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. Despite several years of research, there is still no agreement within the literature regarding the selection of TENS parameters. It is aimed to investigate two types of TENS frequencies (TENS1 alternating between 4 to 100 Hz and TENS2 alternating between 80 to 100 Hz) compared to sham-TENS.
Detailed description
Midwives and the study investigator will ask parturients, who are admitted to the labor ward at Region Hospital Herning satisfying the inclusion and exclusion criteria, whether they are interested in attending the experimental session.
The study will be conducted as soon as the subject is admitted at the labor ward. The study will only be conducted during early and active labor and not during the birth of the baby.
The subject in this study includes the package of a parturient and her neonate (after birth) as we also obtain data about the neonate. Hereby, two consent forms will be obtained. As this study is a non-invasive study, it is decided to have at least the consent of one parent.
The investigator will fill out a questionnaire about the parturient in cooperation with the subject and midwife, including screening questions related to inclusion and exclusion criteria before the experimental session starts.
The study will last approximately one hour and will be conducted during laboring circumstances. KT (Kenoja Thuvarakan) will carry out the experiment, and she will be present in the delivery room during the whole session.
The study includes several outcomes, including subjective and semi-objective pain measures. The primary outcome is VAS (0-10 cm scale), while secondary outcomes include PPT and satisfaction questionnaire (only at the end of the study). The subjects will be asked before, and immediately after the experimental exposure about the four outcomes (VAS and PPT). The subjects will be exposed to one of the two combinations of TENS stimulation (low and high alternating frequency), which will be compared to sham-TENS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 3 groups (TENS1, TENS2, and sham)
| Arm | Type | Receives |
|---|---|---|
| TENS1 | Experimental | Device: DS5 electrical stimulatorTENS with 4/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted. |
| TENS2 | Experimental | Device: DS5 electrical stimulatorTENS with 80/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted. |
| Sham-TENS | Sham comparator | Device: DS5 electrical stimulatorSham with 100 Hz in frequency, 200 µs in pulse duration, and intensity below 5 mA. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Between ages 18-39 years
- Vertex presentation
- Speak, read and understand Danish
- At term (37-42 weeks gestation age)
Key exclusion criteria (14 listed)
- High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension, and hypotension, intrauterine growth restriction, polyhydramnios, and oligohydramnios).
- Pre-gestational body mass index above 40 kg/m2
- Use of fetal-scalp electrode during the experiment
- Use of pacemakers and other electronic implants
- Severe arrhythmia
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 |
|---|---|---|
| DS5 electrical stimulatorTENS | Device | Sham-TENS, TENS1, TENS2 |
Primary outcome
Change in Visual Analog scale (VAS)
Time frame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
10-cm pain intensity scale with 0 cm is no pain and 10 cm is unbearable pain. Decreased cm after baseline measurement indicates pain relief.
Change in Pain pressure threshold
Time frame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
Pain sensitivity measurement also defined as the minimum pressure needed to evoke a pain response measured in kPa. Increased kPa after baseline measurement indicates pain relief.
4 secondary outcomes
Satisfaction of TENS
Time frame: Right after last measurements of VAS & PPT
Experienced pain reduction
Time frame: Right after last measurements of VAS & PPT
Interest in the use of TENS again
Time frame: Right after last measurements of VAS & PPT
Recommend TENS to others
Time frame: Right after last measurements of VAS & PPT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No. Individual participant data is described in Danish and therefore no plan of sharing.
Related trials for Labor Pain
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Recruiting
A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
Labour Analgesia
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.
Parisa Gazerani, PhD study director
Aalborg 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 DS5 electrical stimulator in people with Labor Pain, run by Aalborg University at 1 site in Denmark.
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 5 inclusion and 14 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 28 Jul 2021. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Visual Analog scale (VAS) (time frame: Baseline, 10 minutes post stimulation, 30 minutes post stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2021; AzTrials last refreshed its copy on 1 Nov 2026.