Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation During Delivery

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation
• Intervention / Treatment: Device: transcutaneous electrical nerve stimulation device

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem Akbas, PhD; Phone Number: +905065146780; Email: makbaskanat@gmail.com

Study Locations

• Turkey
  • Sarıcam
    • Adana, Sarıcam, Turkey, 01330
      • Recruiting
      • Cukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Device: transcutaneous electrical nerve stimulation device; 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.
Sham Comparator: Control Group	Device: transcutaneous electrical nerve stimulation device; 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.
Active Comparator: Active TENS 1 Group	Device: transcutaneous electrical nerve stimulation device; 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.
Active Comparator: Active TENS 2 Group	Device: transcutaneous electrical nerve stimulation device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Anticipated): May 20, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 21, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CukurovaU TYL-2020-12916

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No