]>
IRCT20161126031117N9 IRCT 2019-03-10 Mazandaran University of Medical Sciences The effect of hypnosis on preterm labor The effect of hypnosis on the number and severity of uterine contractions, the latency of delivery and neonatal apgar score in women with preterm delivery in two groups of intervention (hypnosis) and control 2019-04-04 anticipated 40 Complete https://irct.ir/trial/36339 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Recording uterine contractions by Toco machine before and after Hypnosis, Randomization description: The samples will be divided into two A and B groups by drawing randomly. Each group contains 20 samples. Forty A and B cards will be put in a container. Every participant, with inclusion criteria, will be asked to pick up a card. The taken card indicates the group. If two participants will be accepted simultaneously, the first drawing will be done and the second sample will not be participated in the study till the end of first participant’s intervention (Hypnosis). N/A preterm labor. Intervention 1: . Intervention group: In this group, hypnosis will be done and if delivery hasn't occurred, in addition to routine treatments, the mothers will be taught self-hypnosis and self-hypnosis CDs will be distributed among mothers by the researcher. Hypnosis intervention will take 7 hours, on average, which will be done in four 1.5-hour sessions. The sessions will be conducted every day. If the patient will be discharged, the sessions will be continued the day after discharge, in a suitable place. Daily survey on home exercises will be done by researcher through phone contact. Intervention 2: Control group: control group: Mothers in this group receive routine treatments and there will be no medicinal interventions. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people. When: Start the access period 6 months after printing the results To whom: Data will only be available to researchers in academia and academia. Conditions: Data will be provided to researchers in accordance with the principle of confidentiality. Where to obtain: Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery school, Vesal street, AmirMazandarani Boulvard. khanisog343@gmail.com How to obtain: After emailing and sending the profile, it will be sent within a week. Comments:
public Soghra khani
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 4817918479 +98 11 3336 8918 s.khani@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr. Soghra khani
Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran Sari Mazandaran
Sari Iran (Islamic Republic of) 4817918479 +98 11 3336 7342 s.khani@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Preterm labor, recognizing regular uterine contractions by physical examination and recording uterine activity by Toco machine, during 25-37 weeks pregnancy or 24 weeks pregnancy if fetal weight estimation is more than 750gr or if cervical dilatation is more than 1cm No signs of severe depression Dilatation less than 4cm while reception No suicidal or self-harm thoughts No signs of paranoid personality, anti-social and psychosis disorders in clinical interviews by psychologist No signs of placental abruption in diagnostic ultrasonography imaging and clinical symptoms No signs of pre-eclampsia diagnosed by gynecologist Diagnostic criteria: Blood pressure equal or more than 140/90 mmHg after 20 weeks pregnancy and Proteinuria equal or more than 300 mg in 24 hours No sign of fetal distress is diagnosed by gynecologist. Diagnostic criteria: no variability patterns or decreased variability less than 5 beats per minute (bpm) with late deceleration or moderate-to-severe variable deceleration, or beat pattern less than 110bpm for 10minutes or more No rupture of membranes without any history of sudden and severe vaginal discharge diagnosed by experienced gynecologist through vaginal examination 15 years 49 years Female Mother's addiction Maternal chronic -systemic diseases 060 preterm labour and delivery Treatment - Other Treatment - Other . Intervention group: In this group, hypnosis will be done and if delivery hasn't occurred, in addition to routine treatments, the mothers will be taught self-hypnosis and self-hypnosis CDs will be distributed among mothers by the researcher. Hypnosis intervention will take 7 hours, on average, which will be done in four 1.5-hour sessions. The sessions will be conducted every day. If the patient will be discharged, the sessions will be continued the day after discharge, in a suitable place. Daily survey on home exercises will be done by researcher through phone contact. Control group: control group: Mothers in this group receive routine treatments and there will be no medicinal interventions Severity and number of uterine contractions. Timepoint: Before doing hypnosis, after doing hypnosis, and then every one hour till dilatation 4cm and in control group every one hour till dilatation 4cm. Method of measurement: The on line analysis of the mechanical (TOCO). Amount of felt pain. Timepoint: Immediately after determining the groups and then after doing hypnosis in intervention group. Method of measurement: Visual Analog Scale (VAS). Birth weight and Apgar score. Timepoint: Immediately after birth. Method of measurement: Digital scale and Apgar. Age of pregnancy in termination time. Timepoint: In termination time. Method of measurement: According to the first day of the last menstrual period and ultrasonography imaging of early pregnancy. Mother's anxiety. Timepoint: In termination time. Method of measurement: Pregnancy Related Anxiety Questionnaire (PRAQ 17). Time from intervention to delivery. Timepoint: before intervention and at delivery. Method of measurement: document the time. Mazandaran University of Medical Sciences Approved 2018-12-03 Ethics committee ofEthics committee of Mazandaran University of Medical sciences University of Medic Vice –Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square Sari Mazandaran Iran (Islamic Republic of)