Evaluation Effect of TENS in Lumbar & acupuncture on the reduction of Labor Pain
Design
In this study, 84 eligible pregnant women referring to maternity wards of Al-Zahra government Hospital in Rasht to be admitted for delivery in 2017, will be selected . Mothers are randomly assigned to four groups of A, B, C, D with a randomized balance block method of 1: 1: 1: 1 ratio.
Settings and conduct
This clinical trial study will be carried out to reduce the pain of normal labor during the delivery period at the Al-Zahra State Hospital in Rasht.Random sequences will be generated using the Random Generator program and will be assigned to the serial number in closed envelopes in the acceptance section and will be awarded to eligible individuals who are enrolled in the study, respectively. The code is recorded in the Patient Information Collection Form. The first operator (experienced medical staff experienced in labor and trained to use tennis at the relevant points) uses TENS on the bedside of mothers. The patient and the pain outcome evaluator (second operator) are not aware of the nature of the codes (double blind study).
Participants/Inclusion and exclusion criteria
Pregnant women aged 35-18 years old, Pregnancy age 41-37 weeks, single fetus with Cephalic presentation؛ Without the use of epidural analgesia or narcotics 12-24hours before entering the study, without the experience of using TENS or acupressure, absence of skin diseases in the area of intervention, absence of high risk pregnancie
Intervention groups
Four intervention groups are: A) Placebo control (Inactive lumbar and acupuncture TENS group). B) Active acupuncture TENS group. C) Active lumbar TENS group. D) Active lumbar and acupuncture TENS group
Main outcome variables
Pain severity score؛TENS satisfaction score؛ latent phase duration؛ active phase duration؛ first minute apgar؛ neonate fifth minute apgar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080826001096N6
Registration date:2018-05-02, 1397/02/12
Registration timing:registered_while_recruiting
Last update:2018-05-02, 1397/02/12
Update count:0
Registration date
2018-05-02, 1397/02/12
Registrant information
Name
Seyede Hajar Sharami
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
sharami@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison Effect of Transcutaneouse Electrical Nerve Stimulation (TENS) in Lumbar & acupuncture points in reducing Labor Pain
Public title
Effect of TENS on the reduction of labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 35-18 years old
Having reading and writing skills
The gestational age: 41-37 weeks
Single pregnancy
Cephalic fetal presentation
Latent phase of labor (dilatation less than 4-3 cm)
Exclusion criteria:
Use of epidural analgesia or other anesthetics within 24 hours before entering the study
The experience of using TENS or Acupuncture
The use of oxytocin to induce and augmentation of labor before entering the study
Mental and anatomical disorders (psychosis, schizophrenia, uterine abnormalities and pelvic stenosis)
chronic diseases (heart disease, hypertension, diabetes)
Skin diseases e (any lesion, inflammation and eczema) in the area of intervention
high risk pregnancies (gestational hypertension, polyhydramnios and oligohydramnios known by ultrasound)
Reduce fetal movements before entering the study
Intrauterine growth retardation (IUGR)
Rupture of membrane for more than 12 hours
Use narcotics 12 hours before entering the study
Infertility history
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Mothers are randomly assigned to four groups of A, B, C, D with a randomized balance block method of 1: 1: 1: 1 ratio. Random sequences will be generated using the Random Generator program and will be assigned to the serial number in closed envelopes in the acceptance section, and will be given to eligible individuals who are enrolled in the study, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Labor practitioners (the first operator) who have been trained to interview and complete the form and application of TENS on the suitable points, will be conducted on the mothers bedside. The relevant code is recorded in the patient's information collection form. The operator completes the demographic characteristics and delivery process of each patient in the coded form according to the medical records. The patient and the outcome evaluator of pain (second operator) do not know the nature of the codes (double blind study).
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
• Ethics committee of Guilan University of Medical Sciences
Street address
Research vice-chancellorship Building, in front of 17-Shahrivar Hospital, Shahid Siadati St., Namjoo Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
66949- 41446
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.GUMS.REC.1396.300
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O83.9
ICD-10 code description
Assisted single delivery, unspecified
Primary outcomes
1
Description
Pain severity score
Timepoint
1. The beginning of the study, 2.One hour after the close of TENS 3.The beginning of the active phase (dilation of 4-5 cm) 4.The end of the first phase (full dilatation)
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
1
Description
TENS satisfaction score
Timepoint
4 hours after childbirth
Method of measurement
Researcher made 3 questions questionnaire
Intervention groups
1
Description
Placebo control (Inactive lumbar and acupuncture TENS group): Lumbar and acupuncture points electrodes will be connected to the study participants and will receive very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports a tingling sensation. This flow is not repeated until the end of the first stage of labor. The pain score according to the schedule is measured in four stages.
Category
Placebo
2
Description
Intervention group: B) Active acupuncture TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The acupuncture points TENS machine is in the hands of the trained operator. Based on body weight of the participants, the output current is stabilized at 10 to 18 mA. For a person of higher weight, you need to provide more effective electrical stimulation, which elicits a tingling sensation. For each mother, for half an hour, pulse are sent to acupuncture points. Repeated applications of TENS will be sent upon mother's request (up to 4 phase ).The lumbar TENS machine is placed in the hands of the mother. Lumbar electrode-pads will receive very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports a tingling sensation. This flow is not repeated until the end of the first stage of labor. The pain score according to the schedule will be measured in four stages.
Category
Treatment - Devices
3
Description
Intervention group: Active Lumbar TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The Lumbar TENS machine is in the hands of the mother. The mother is taught how to increase the degree of electrical pulse with the onset of pain, which is the most pain-relieving effect, with the slightest sensation of tingling (Burst waves). Each time the contractions of labor, Boost waves sent by the mother. In this way, the pulse of the lumbar electrodes is sent to the mother's self-diagnosis to reduce pain at the onset of contractions. Then, the mother takes an active role. The acupuncture points TENS machine is in the hands of the trained operator. The acupuncture points electrodes sends very little stimulation (at 5 mA) without changing the frequency in a few seconds, so that the mother reports an tingling transient sensation. This electrical current is not repeated until the end of the first stage of labor. The pain score according to the schedule will be measured in four stages.
Category
Treatment - Devices
4
Description
Intervention group: Active lumbar and acupuncture TENS group: Lumbar and acupuncture points electrode-pads will be connected to the study participants. The Lumbar TENS machine is in the hands of the mother. The mother is taught how to increase the degree of electrical pulse with the onset of pain, which is the most pain-relieving effect, with the slightest sensation of tingling (Burst waves). Each time the contractions of labor, Boost waves sent by the mother.The acupuncture points TENS machine is in the hands of the trained operator. For each mother, for half an hour, pulse are sent to acupuncture points. Repeated applications of TENS will be sent upon mother's request (up to 4 phase ). The pain score according to the schedule will be measured in four stages.