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Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation During Delivery

Primary Purpose

Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transcutaneous electrical nerve stimulation device
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Sham Comparator

Arm Label

Active TENS 1 Group

Active TENS 2 Group

Placebo Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2021
Last Updated
April 14, 2021
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT04851938
Brief Title
Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation During Delivery
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Hormone, Labour, Pain, Midwife, Pregnant, Transcutaneous Electrical Nerve Stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TENS 1 Group
Arm Type
Active Comparator
Arm Title
Active TENS 2 Group
Arm Type
Active Comparator
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Title
Control Group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical nerve stimulation device
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain perception and anxiety
Description
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.
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meltem Akbaş, Phd
Phone
+905065146780
Email
makbaskanat@gmail.com
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sarıcam
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Evaluation of the Effect of Transcutaneous Electrical Nerve Stimulation During Delivery

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