The purpose of this study is to investigate the effect of hypnosis on the severity of pain in the first stage of labor in primiparous women.
Design
In this study, 64 pregnant women referred to health centers in Sabzevar who are eligible to enter the study are selected. Participants are randomly divided into intervention and control groups and each code is assigned to hide the intervention group of each participant.
Settings and conduct
The both Intervention and control groups from the 32nd week of gestation are trained for 8 sessions (twice a week) in an educational class at Mobini Hospital in Sabzevar city. The control group is trained about stages of delivery, prenatal care, risk symptoms, baby care and ... by a midwifery master and in the intervention group, in addition, hypnosis is trained by a single hypnotherapist and hypnosis conditioning is done. During the first stage of labor, a hypnotherapist along with a midwife who has been trained in the field of hypnosis, are present in place and carries out conditioning procedures for the intervention group. In the control group, routine care is performed during labor. The Visual Analog Scale Questionnaire for pain measurement is completed in both groups during labor and after delivery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
nulliparous women
age of 23 to 35 years
gestational age of 30 to 32 weeks at the start of the study
normal fetus in ultrasound scans
not having contraindications for vaginal delivery
having at least primary education
Singleton pregnancy
having normal BMI
Exclusion criteria:
history of psychotherapy or mental disease
cigarette, opioid, and alcohol addiction
history of repetitive abortion and infertility.
Intervention groups
Intervention group from the 32nd week of gestation are hypnotized by hypnotherapist for 6 sessions (weekly). During the first stage of labor, hypnosis is also done by a hypnotherapist.
Main outcome variables
Severity of labor pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161222031519N2
Registration date:2018-04-04, 1397/01/15
Registration timing:registered_while_recruiting
Last update:2018-04-04, 1397/01/15
Update count:0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
Zahra Zare
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8301
Email address
zarez@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hypnosis on pain severity of the first stage of labor in primiparous women
Public title
The effect of hypnosis on the severity of labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: first pregnancy, age of 20 to 35 years, gestational age 30- 32 weeks at the begining of the study, healthy and normal fetus in ultrasound survey ، not having detectable barriers to normal delivery, singleton pregnancy, no history of mental disorder, no addiction to cigarettes, drugs and alcohol.
Exclusion criteria:
Termination of pregnancy for any reason before the end of the sessions
Indication for cesarean delivery
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The research units were divided into two intervention and control groups by simple randomization method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Boulevard Nuclear Martyrs,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114- 96179131
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.MEDSAB.REC.1394.69
Health conditions studied
1
Description of health condition studied
Relationship hypnosis with pain severity of first stage of labor in primiparous women.
ICD-10 code
E084, E080
ICD-10 code description
single spontaneous delivery
Primary outcomes
1
Description
Severity of labor pain
Timepoint
Study of pain severity 4 times in the first stage of labor in dilatation of 4.6, 8 and 10 cm
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group": from the 32 weeks of gestational age for 8 sessions (twice a week), they are trained about stages of delivery, prenatal care, risk symptoms, baby care and ... by a midwifery master. In addition, hypnosis is trained by a single hypnotherapist and conditioning hypnosis is done. During the first stage of labor, a hypnotherapist is present at the site and carries out the conditioning process.
Category
Treatment - Other
2
Description
Control group: During labour, they receive routine care.