Effect of Benson's relaxation training versus no training on the severity of nausea and vomiting and quality of life in pregnant women: a randomized clinical trial
To assess the effect of Benson's relaxation training versus no training on the severity of nausea and vomiting and quality of life in pregnant women
Design
This is a randomized clinical trial, phase II, in which 100 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible pregnant women who will refer to Comprehensive Health Centers in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 30 years,
First pregnancy, singleton with the live fetus,
Gestational age of 6 to 10 weeks,
Nausea and vomiting,
Literate
Exclusion criteria:
High-risk pregnancy,
History of infertility,
Pyelonephritis,
Thyroid disorder,
Gastrointestinal disease,
Mental disease,
Using alcohol, narcotics or cigarette
Intervention groups
Intervention group:
Routine pregnancy period plus face-to-face training Benson's relaxation during three consecutive sessions each session 45 to 60 minutes
Control group:
Just routine pregnancy period
Main outcome variables
Primary outcome:
Nausea and vomiting
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N307
Registration date:2019-10-12, 1398/07/20
Registration timing:prospective
Last update:2019-10-12, 1398/07/20
Update count:0
Registration date
2019-10-12, 1398/07/20
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
2019-11-01, 1398/08/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Benson's relaxation training versus no training on the severity of nausea and vomiting and quality of life in pregnant women: a randomized clinical trial
Public title
Effect of Benson's relaxation training versus no training on the severity of nausea and vomiting and quality of life in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 30 years,
First pregnancy, singleton with live fetus,
Gestational age of 6 to 10 weeks,
Nausea and vomiting,
Literate
Exclusion criteria:
High-risk pregnancy,
History of infertility,
Pyelonephritis,
Thyroid disorder,
Gastrointestinal disease,
Mental disease,
Using alcohol, narcotics or cigarette
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the Comprehensive Health Centers to the intervention and control groups through the drawing of lots. To do this, we will write the names of the Comprehensive Health Centers on the paper sheets. Then, we draw one sheet at a time and assign the Comprehensive Health Centers to the intervention or control group.
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
2019-08-10, 1398/05/19
Ethics committee reference number
IR.UMSHA.REC.1398.424
Health conditions studied
1
Description of health condition studied
Pregnancy nausea and vomiting
ICD-10 code
O21
ICD-10 code description
Excessive vomiting in pregnancy
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Before the intervention and at the end of fourth week after the intervention
Method of measurement
Using PUQE-24 questionnaire
2
Description
Quality of life
Timepoint
Before the intervention and at the end of fourth week after the intervention
Method of measurement
Using SF-36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine pregnancy period plus face-to-face training Benson's relaxation during three consecutive sessions each session 45 to 60 minutes
Category
Other
2
Description
Control group: Just routine pregnancy period
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Zahra Jadidi
Street address
School of Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
jadidi.zahra77@gmail.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
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
Zahra Jadidi
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
jadidi.zahra77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Soodabeh Aghababaii
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aghababaii@yahoo.com
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