Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve StimulationNCT04851938
Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation During Delivery
A study testing transcutaneous electrical nerve stimulation device in people with Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Pain and anxiety levels experienced during labour are important factors affecting mother and baby health. An indicator that affects these factors is the levels of hormones that special for birth in the mother's blood. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation
- What is being tested?
- transcutaneous electrical nerve stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 1 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 38-42 "week of pregnancy"
- Who will give normal vaginal delivery
- Dilatation of 4 cm and above
- Single fetus and head presentation
- Can speak Turkish and communicate
- Agreeing to participate in the study
- Not having risky pregnancy
Who cannot join
- Application of induction
- Using birth analgesia / anesthesia
- With pacemakers
- With skin damage in the area where TENS will be applied
- With any skin disease
- With contraction anomalies
- With epilepsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cukurova University
Adana, Sarıcam, 01330
About this study
Official title: Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation Applied In Different Frequencies on Hormone Levels, Birth Pain Perception and Anxiety During Delivery
Pain and anxiety levels experienced during labour are important factors affecting mother and baby health. An indicator that affects these factors is the levels of hormones that special for birth in the mother's blood. The application of transcutaneous electrical nerve stimulation is a nonpharmacological method that midwives can apply and determining the effect on these factors will be a guide for the future applications.
The research will be conducted between 20 March 2020 and 10 March 2021 at the Adana Seyhan State Hospital of the Ministry of Health of the Republic of Turkiye. The universe will be formed by the all pregnant women who are accepted to give birth to the birth room of the named hospital. The number of normal births in the relevant hospital in 2019 is 5979 per year. Power analysis was done with Gpower 3.1 for the number of samples. Báez-Suárez et al. Based on his study, the standard deviation of the pain scale was found as 1.48 and it was determined that at least 25 pregnant women per group with %5 error and %90 strength would be sufficient. It was planned to conduct a study with 28 pregnant women per group, with an increase in the sample size by %10, with the prospect of possible employment. One hundred and twelve pregnant women selected among pregnant women will be divided into 4 groups using a simple randomisation method and a random sequence will be created. Active transcuteneous electrical nerve stimulation at different doses will be applied to the two groups and the third group will be set as a placebo group. In the active phases of labour, active trancutaneous electrical nerve stimulation, which is adjusted to the first group of the pregnant women with a cervical aperture of at least 4 cm, modified biphasic asymmetric pulseand it was set to a pulse width of 100 μs and a frequency of 100 Hz (1). In the active transcutaneous electrical nerve stimulation second group, it emitted an asyymetric, balanced, biphasic square waveform at a mixed stimulating frequency that randomly varied between 80 and 100 Hz, and it had a pulse duration of 350 μs (2) will be applied for 30 minutes. Transcutaneous electrical nerve stimulation electrodes will be connected to the placebo group and 30 minutes will be waited without electric application. Transcutaneous electrical nerve stimulation electrodes will be connected to the control group and 30 minutes will be waited without electric application. Transcutaneous electrical nerve stimulation will be connected to the spinal cord in parallel with the levels of T10-L1 and S2-4 with two adhesive electrodes. Before and after transcutaneous electrical nerve stimulation application to pregnant women, hormon levels, visual analogue scale (VAS), pain assessment, state worry scale for anxiety assessment will be performed. Statistical Package for the Social Sciences 20.0 program will be used in the analysis of the data.
Birth pain is one of the most common types of pain. Various studies have been conducted on whether or not birth pain can be effectively reduced with transcutaneous electrical nerve stimulation application. However, no study evaluating the effect of transcutaneous electrical nerve stimulation application at different frequencies during delivery as a placebo controlled and double blind experimental study in terms of perception of birth pain, anxiety, hormon levels such as endrophin, oxytocin and cortisol was not found. Therefore, this study will be conducted as a randomised controlled experimental study to evaluate the effect of transcutaneous electrical nerve stimulation on birth pain, endorphine level, anxiety and satisfaction during delivery.
- Conditions
- Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation
- Being tested
- transcutaneous electrical nerve stimulation device
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulation deviceDevice
The application of transcutaneous electrical nerve stimulation is a nonpharmacological method that midwives can apply and determining the effect on these factors will be a guide for the future applications.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS 1 Group | Active comparator | Not described Receives: Device: transcutaneous electrical nerve stimulation device |
| Active TENS 2 Group | Active comparator | Not described Receives: Device: transcutaneous electrical nerve stimulation device |
| Placebo Group | Placebo comparator | Not described Receives: Device: transcutaneous electrical nerve stimulation device |
| Control Group | Sham comparator | Not described Receives: Device: transcutaneous electrical nerve stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain perception and anxiety
Pain and anxiety levels experienced during labour are important factors affecting mother and baby health. For pain perseption VAS scale was used. For anxiety state anxiety scale was used.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start20 Mar 2020
- Primary completion20 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve StimulationStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Sülü, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851938
- Sponsor's protocol ID
- CukurovaU TYL-2020-12916
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation Applied In Different Frequencies on Hormone Levels, Birth Pain Perception and Anxiety During Delivery
- ClinicalTrials.gov ID
- NCT04851938
- Acronym / sponsor ID
- CukurovaU TYL-2020-12916
- Conditions
- Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 21 Apr 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.
Pain and anxiety levels experienced during labour are important factors affecting mother and baby health. An indicator that affects these factors is the levels of hormones that special for birth in the mother's blood. The application of transcutaneous electrical nerve stimulation is a nonpharmacological method that midwives can apply and determining the effect on these factors will be a guide for the future applications.
The research will be conducted between 20 March 2020 and 10 March 2021 at the Adana Seyhan State Hospital of the Ministry of Health of the Republic of Turkiye. The universe will be formed by the all pregnant women who are accepted to give birth to the birth room of the named hospital. The number of normal births in the relevant hospital in 2019 is 5979 per year. Power analysis was done with Gpower 3.1 for the number of samples. Báez-Suárez et al. Based on his study, the standard deviation of the pain scale was found as 1.48 and it was determined that at least 25 pregnant women per group with %5 error and %90 strength would be sufficient. It was planned to conduct a study with 28 pregnant women per group, with an increase in the sample size by %10, with the prospect of possible employment. One hundred and twelve pregnant women selected among pregnant women will be divided into 4 groups using a simple randomisation method and a random sequence will be created. Active transcuteneous electrical nerve stimulation at different doses will be applied to the two groups and the third group will be set as a placebo group. In the active phases of labour, active trancutaneous electrical nerve stimulation, which is adjusted to the first group of the pregnant women with a cervical aperture of at least 4 cm, modified biphasic asymmetric pulseand it was set to a pulse width of 100 μs and a frequency of 100 Hz (1). In the active transcutaneous electrical nerve stimulation second group, it emitted an asyymetric, balanced, biphasic square waveform at a mixed stimulating frequency that randomly varied between 80 and 100 Hz, and it had a pulse duration of 350 μs (2) will be applied for 30 minutes. Transcutaneous electrical nerve stimulation electrodes will be connected to the placebo group and 30 minutes will be waited without electric application. Transcutaneous electrical nerve stimulation electrodes will be connected to the control group and 30 minutes will be waited without electric application. Transcutaneous electrical nerve stimulation will be connected to the spinal cord in parallel with the levels of T10-L1 and S2-4 with two adhesive electrodes. Before and after transcutaneous electrical nerve stimulation application to pregnant women, hormon levels, visual analogue scale (VAS), pain assessment, state worry scale for anxiety assessment will be performed. Statistical Package for the Social Sciences 20.0 program will be used in the analysis of the data.
Birth pain is one of the most common types of pain. Various studies have been conducted on whether or not birth pain can be effectively reduced with transcutaneous electrical nerve stimulation application. However, no study evaluating the effect of transcutaneous electrical nerve stimulation application at different frequencies during delivery as a placebo controlled and double blind experimental study in terms of perception of birth pain, anxiety, hormon levels such as endrophin, oxytocin and cortisol was not found. Therefore, this study will be conducted as a randomised controlled experimental study to evaluate the effect of transcutaneous electrical nerve stimulation on birth pain, endorphine level, anxiety and satisfaction during delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active TENS 1 Group | Active comparator | Device: transcutaneous electrical nerve stimulation device |
| Active TENS 2 Group | Active comparator | Device: transcutaneous electrical nerve stimulation device |
| Placebo Group | Placebo comparator | Device: transcutaneous electrical nerve stimulation device |
| Control Group | Sham comparator | Device: transcutaneous electrical nerve stimulation device |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 38-42 "week of pregnancy"
- Who will give normal vaginal delivery
- Dilatation of 4 cm and above
- Single fetus and head presentation
- Can speak Turkish and communicate
Key exclusion criteria (7 listed)
- Application of induction
- Using birth analgesia / anesthesia
- With pacemakers
- With skin damage in the area where TENS will be applied
- With any skin disease
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 deviceThe application of transcutaneous electrical nerve stimulation is a nonpharmacological method that midwives can apply and determining the effect on these factors will be a guide for the future applications. | Device | Active TENS 1 Group, Active TENS 2 Group, Control Group, Placebo Group |
Primary outcome
pain perception and anxiety
Time frame: 30 minutes
Pain and anxiety levels experienced during labour are important factors affecting mother and baby health. For pain perseption VAS scale was used. For anxiety state anxiety scale was used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
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.
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 device in people with Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation, run by Cukurova University at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Apr 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meltem Akbaş, Phd (+905065146780, makbaskanat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain perception and anxiety (time frame: 30 minutes). 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 21 Apr 2021.