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
Determining the effect of hypnosis on the number and severity of uterine contractions, the latency of labor and neonatal apgar score in women with preterm delivery in two groups of intervention (hypnosis) and control
Design
Two arm parallel groups randomized trial with preterm labor women and outcome assessment
Settings and conduct
Demographic characteristics and the anxiety questionnaire will be completed after the diagnosis of preterm labor. In eligible cases, random allocating will be performed. Pain will be assessed by the Visual Analogue Scale. Uterine Contractions will be recorded. Hypnosis will be done. At the time of termination of pregnancy in two groups, duration of delivery delay and neonate Apgar score and the mother's anxiety will be assessed by a collaborator (one person per shift). Data analysis and design contributors are blind to groups.
Participants/Inclusion and exclusion criteria
Preterm labor 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 or anti-social personality;
No signs of placental abruption;
No signs of pre-eclampsia;
No sign of fetal distress;
No rupture of membranes;
Maternal addiction;
Maternal chronic -systemic diseases
Intervention groups
Mothers, in group A, receive routine treatments and there will be no medicinal interventions. In group B, hypnosis will be done in addition to routine treatments and the mothers will be taught self-hypnosis and self-hypnosis CDs will be distributed among mothers by the researcher. Hypnosis intervention will take 6 hours, on average, which will be done in four 1.5-hour sessions. The sessions will be conducted every day. Daily survey on home exercises will be done by researcher.
Main outcome variables
uterine contraction; duration between start of treatment and delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031117N9
Registration date:2019-03-10, 1397/12/19
Registration timing:prospective
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of hypnosis on preterm labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
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).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Recording uterine contractions by Toco machine before and after Hypnosis
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofEthics committee of Mazandaran University of Medical sciences University of Medic
Street address
Vice –Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.MAZUMS.REC.97.3253
Health conditions studied
1
Description of health condition studied
preterm labor
ICD-10 code
060
ICD-10 code description
preterm labour and delivery
Primary outcomes
1
Description
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)
2
Description
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).
3
Description
birth weight and Apgar score
Timepoint
Immediately after birth
Method of measurement
Digital scale and Apgar
4
Description
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
5
Description
Mother's anxiety
Timepoint
In termination time
Method of measurement
Pregnancy Related Anxiety Questionnaire (PRAQ 17)
Secondary outcomes
1
Description
time from intervention to delivery
Timepoint
before intervention and at delivery
Method of measurement
document the time.
Intervention groups
1
Description
. 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.
Category
Treatment - Other
2
Description
Control group: control group: Mothers in this group receive routine treatments and there will be no medicinal interventions
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Sari
Full name of responsible person
Dr. Soghra Khani
Street address
Amir Mazandaran Boullevard
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
s.khani@mazums.ac.ir
2
Recruitment center
Name of recruitment center
Shafa Hospital, Sari
Full name of responsible person
Dr. Soghra Khani
Street address
Mahyar, Sari
City
Sari
Province
Mazandaran
Postal code
59777 - 48178
Phone
+98 11 3320 5006
Fax
Email
sarishafahospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Hedayati Zadeh
Street address
Vice Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square, Moalem Street. sari Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3325 7230
Fax
+98 11 3325 7231
Email
akbar_hedayati@mazums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Soghra khani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3336 8918
Email
s.khani@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghra khani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran Sari Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 11 3336 7342
Email
s.khani@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghra khani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery Faculty, Vesal street, sari, Mazandaran Sari Mazandaran
City
Sari
Province
Mazandaran
Postal code
4817918479
Phone
+98 113367342
Email
s.khani@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers in academia and academia.
Under which criteria data/document could be used
Data will be provided to researchers in accordance with the principle of confidentiality.
From where data/document is obtainable
Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery school, Vesal street, AmirMazandarani Boulvard. khanisog343@gmail.com
What processes are involved for a request to access data/document
After emailing and sending the profile, it will be sent within a week.