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IRCT20151103024866N15 IRCT 2021-06-04 Kerman University of Medical Sciences Comparison of electrical nerve stimulation with and without flow through the skin (TENS) with supportive psychological intervention on labor pain and its maternal and neonatal consequences in pregnant women Comparison of electrical nerve stimulation with and without flow through the skin (TENS) with supportive psychological intervention on labor pain and its maternal and neonatal consequences in pregnant women 2021-06-10 anticipated 90 Complete https://irct.ir/trial/56645 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The lottery method was used for randomization. In such a way that on three papers, one number 1, one number 2 and one number 3 were written. The papers were folded and each pregnant woman who was eligible to enter the study picked up one of these papers. Number 1 was the tennis group, number 2 was the counseling group, and number 3 was the control group, Blinding description: The researcher divided the people into three groups by lottery and the intervention was performed by the researcher. But the assessor of the outcome was the midwife who performed the delivery and had no knowledge of the intervention or control, nor did the data analyzer know the individuals. N/A pain level during childbirth. Intervention 1: Intervention group: Tens group: With the start of the active phase of labor (cervical dilatation ≥4), the MAXTENS 2000 tennis device with two pairs of electrodes will be used, so that the upper electrodes between the L1-T10 vertebrae and the lower electrodes between the S2-S4 vertebrae at a distance of 7 cm on both sides of the spine Are placed. The device is set with continuous current, frequency of 100 Hz per minute and wavelength of 250 microseconds and continues until the beginning of the second stage of labor (dilation 10 cm). Intervention 2: Intervention group: Supportive and psychological Counselling group: The trained midwife has been present in the counseling group since the active phase of labor. Expressing energetic and hopeful sentences, teaching breathing and relaxation techniques during and in between contractions, promoting female self-esteem during childbirth and performing mindfulness techniques are the main cases of psychological supportive intervention. Intervention 3: Control group: The control group performs routine labor care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Katayoun Alidousti
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 kalidousti@gmail.com Kerman University of Medical Sciences scientific Katayoun Alidousti
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 kalidousti@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) The first delivery Iranian nationality Age 40-18 Having gestational age of 41-37 weeks Single pregnancy Cephalic presentation The active phase of labor has begun (dilatation ≥4) 18 years 40 years Female History of epidural analgesia Presence of a sore or scar or inflammation at the junction of the tens probe with with a pacemaker Has a chronic underlying disease used painkillers 3 hours before the intervention and during the intervention Addicted to cigarettes and drugs and alcohol Have a clear and recognizable barrier to normal delivery at the time of sampling Have a history of cesarean section Diagnosed, untreated mental illness Treatment - Other Behavior N/A Intervention group: Tens group: With the start of the active phase of labor (cervical dilatation ≥4), the MAXTENS 2000 tennis device with two pairs of electrodes will be used, so that the upper electrodes between the L1-T10 vertebrae and the lower electrodes between the S2-S4 vertebrae at a distance of 7 cm on both sides of the spine Are placed. The device is set with continuous current, frequency of 100 Hz per minute and wavelength of 250 microseconds and continues until the beginning of the second stage of labor (dilation 10 cm). Intervention group: Supportive and psychological Counselling group: The trained midwife has been present in the counseling group since the active phase of labor. Expressing energetic and hopeful sentences, teaching breathing and relaxation techniques during and in between contractions, promoting female self-esteem during childbirth and performing mindfulness techniques are the main cases of psychological supportive intervention. Control group: The control group performs routine labor care Pain level during childbirth based on Visual Analogue Scale. Timepoint: At the beginning of the study (dilatation ≥4) and the end of the first stage of labor (dilatation 10 cm). Method of measurement: Visual Analogue Scale for pain. Neonatal Apgar. Timepoint: first and fifth minutes. Method of measurement: Apgar table. Delivery morbidity. Timepoint: during childbirth till one hours postpartum. Method of measurement: observational and gynecologist opinion. Kerman University of Medical Sciences Approved 2020-07-12 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)