To assess the effect of self-hypnosis versus no hypnosis on delivery pain in pregnant women
Design
A randomized clinical trial, phase 2, including 640 patients
Settings and conduct
The eligible pregnant women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 40 years; gestational age of 28 months or over
Exclusion criteria: Chronic diseases such as diabetes or cardiovascular diseases; gestational complications such as gestational diabetes or preeclampsia or preterm labor
Intervention groups
Intervention group: Normal delivery with self-hypnosis train to pregnant woman during 5 one-hour sessions
Control group: Normal delivery without hypnosis
Main outcome variables
Primary outcome: Assessing the severity of pain during delivery using visual analog scale (VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N199
Registration date:2017-12-05, 1396/09/14
Registration timing:prospective
Last update:2017-12-05, 1396/09/14
Update count:0
Registration date
2017-12-05, 1396/09/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-06, 1396/09/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of self-hypnosis versus no hypnosis on delivery pain in pregnant women: a randomized clinical trial
Public title
Comparing effect of self-hypnosis versus no hypnosis on delivery pain in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years
Gestational age of 28 months or over
Exclusion criteria:
Chronic diseases such as diabetes or cardiovascular diseases
Gestational complications such as gestational diabetes or preeclampsia or preterm labor
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
640
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups by writing the names of intervention and control on two sheets and then taking the sheets randomly
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-11-04, 1396/08/13
Ethics committee reference number
IR.UMSHA.REC.1396.522
Health conditions studied
1
Description of health condition studied
Normal delivery
ICD-10 code
O60.2
ICD-10 code description
Term delivery with preterm labor
Primary outcomes
1
Description
Assessing the severity of pain
Timepoint
During delivery
Method of measurement
Using visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Normal delivery with self-hypnosis train to pregnant woman during 5 one-hour sessions
Category
Prevention
2
Description
Control group: Normal delivery without hypnosis
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Mohammad Rasool Abdoli
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mohammad_kola@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Fax
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Rasool Abdoli
Position
Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mohammad_kola@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Soghra Rabiei
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
rabiei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available