To assess the effect of supportive counseling by midwife with and without acupressure on nausea and vomiting in pregnant women
Design
This is a randomized clinical trial, phase II, in which 140 eligible pregnant women 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 35 years;
Gestational age of 8 to 10 weeks;
Nausea and vomiting;
Wanted pregnancy;
Literate
Exclusion criteria:
History of acupuncture or acupressure;
Mental disorders;
Gastric or renal diseases;
Using tobacco or alcohol;
Pregnancy complications
Intervention groups
Intervention group 1:
Routine care during pregnancy plus supportive counseling for 45 to 60 minutes for 3 sessions and bracelet with push button for 14 days
Intervention group 2:
Routine care during pregnancy plus supportive counseling for 45 to 60 minutes for 3 sessions and bracelet without push button for 14 days
Intervention group 3:
Routine care during pregnancy plus supportive counseling for 45 to 60 minutes for 3 sessions
Control group:
Just routine care during pregnancy
Main outcome variables
Primary outcome:
The severity of nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N297
Registration date:2019-09-21, 1398/06/30
Registration timing:prospective
Last update:2019-09-21, 1398/06/30
Update count:0
Registration date
2019-09-21, 1398/06/30
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
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supportive counseling by midwife with and without acupressure on nausea and vomiting in pregnant women: a randomized clinical trial
Public title
Effect of supportive counseling by midwife with and without acupressure on nausea and vomiting in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years;
Gestational age of 8 to 10 weeks;
Nausea and vomiting;
Wanted pregnancy;
Literate
Exclusion criteria:
History of acupuncture or acupressure;
Mental disorders;
Gastric or renal diseases;
Using tobacco or alcohol;
Pregnancy complications
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to four groups through the drawing of lots. To do this, we prepare four sheets and write "A", "B", "C", and "D" on every sheet. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the four groups.
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.1398.422
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
The severity of nausea and vomiting
Timepoint
Before the intervention and 14 days later
Method of measurement
By history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Routine care during pregnancy plus supportive counseling for 45 to 60 minutes for 3 sessions and bracelet with push button for 14 days
Category
Treatment - Other
2
Description
Intervention group 2: Routine care during pregnancy plus supportive counseling for 45 to 60 minutes for 3 sessions and bracelet without push button for 14 days
Category
Treatment - Other
3
Description
Intervention group 3: Routine care during pregnancy plus supportive counseling for 45 to 60 minutes for 3 sessions
Category
Treatment - Other
4
Description
Control group: Just routine care during pregnancy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan City
Full name of responsible person
Azadeh Azadi Mghtader
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
moghtader89@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
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
Azadeh Azadi Mghtader
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
moghtader89@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Masoomi
Position
Fertility Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahra.masoomi@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