Labor PainNCT04946838
Transcutaneous Electrical Nerve Stimulation for Labor Pain Control in Combination With Cardiotocography
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 years and older, women only
- 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
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Jul 2021to 13 Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Vertex presentation
- Speak, read and understand Danish
Who cannot join
- Gestational age < 37+0 weeks
- Gestational age > to 41+6 weeks
- High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension (above 140/90), and hypotension (below 90/60), Intrauterine growth restriction (IUGR), polyhydramnious, and oligohydramnious).
- Pre-gestational body mass index (BMI) above 40 kg/m2
- Use of fetal scalp-electrode during the experiment
- Use of pacemakers and other electronic implants
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- Severe arrhythmia
- Present musculoskeletal illnesses (including myopathy and arthritis).
- Chronic pain within last 6 months (Pelvic girdle pain (PGP) to a mild degree (VAS 0-6 cm) is accepted in the experiment. Severe degree (VAS 6-10 cm) (e.g. bedridden or difficulty walking) especially within 24 hours before birth is excluded).
- Present/previous neurologic illnesses (including epilepsy, migraine, and sclerosis).
- Present medicated mental disorders (including dementia, personality disorders, bipolar, ADHD, and anxiety).
- Dermatological disorders (including skin allergy, tattoos or scars on the locations of electrodes)
- Use of other long-acting pain relief before the experiment (including Epidural, Morphine less than 16 hours before experiment), Acupuncture, Paracetamol (less than 8 hours before experiment), Cocktail (less than 8 hours before experiment), nitrous oxide (less than one hour before experiment), sterile water injection (less than two hours before experiment).
- Use of TENS 48 hours before the trial
- Drug addiction defined 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
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 TENS1 alternating between 4 to 100 Hz compared to sham-TENS.
The present study aims to evaluate TENS in combination with cardiotocography (CTG).
The combination of TENS with CTG in a feedback-loop has not been reported in any studies before.
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 screening questionnaire about the laboring parturient in cooperation with the subject and the 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 outcomes (VAS and PPT). The subjects will be exposed to one of the two combinations of TENS stimulation (low-to-high 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 |
|---|---|---|
| TENS | Experimental | TENS with 4/100 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.
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
Pain pressure threshold (PPT)
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 posted1 Jul 2021
- Study start9 Jul 2021
- Primary completion13 Aug 2021
- Study completion13 Aug 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
- 2 groups (TENS and sham)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Centaflow
- Responsible party
- Principal investigator, Kenoja Thuvarakan, Aalborg University
- Investigators
- Parisa Gazerani, PhD, Study director, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946838
- Sponsor's protocol ID
- 20210423
- Status last verified
- Aug 2021
- First submitted
- 23 Jun 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and individual participant data will be available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation for Labor Pain Control in Combination With Cardiotocography
- ClinicalTrials.gov ID
- NCT04946838
- Acronym / sponsor ID
- 20210423
- Conditions
- Labor Pain
- Keywords
- TENS, Labor pain, Childbirth, RCT, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Centaflow
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 1 Jul 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 TENS1 alternating between 4 to 100 Hz compared to sham-TENS.
The present study aims to evaluate TENS in combination with cardiotocography (CTG).
The combination of TENS with CTG in a feedback-loop has not been reported in any studies before.
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 screening questionnaire about the laboring parturient in cooperation with the subject and the 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 outcomes (VAS and PPT). The subjects will be exposed to one of the two combinations of TENS stimulation (low-to-high 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
- 2
- Model description
- 2 groups (TENS and sham)
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: DS5 electrical stimulatorTENS with 4/100 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 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Vertex presentation
- Speak, read and understand Danish
Key exclusion criteria (17 listed)
- Gestational age < 37+0 weeks
- Gestational age > to 41+6 weeks
- High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension (above 140/90), and hypotension (below 90/60), Intrauterine growth restriction (IUGR), polyhydramnious, and oligohydramnious).
- Pre-gestational body mass index (BMI) above 40 kg/m2
- Use of fetal scalp-electrode during the experiment
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, TENS |
Primary outcome
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.
Pain pressure threshold (PPT)
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 30 Aug 2021.
- Individual participant dataSharing planned: Yes. Study protocol and individual participant data will be available.
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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.
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 3 inclusion and 17 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 30 Aug 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?
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 30 Aug 2021.