The effect of educational intervention based on Ottawa nutritional guidelines on nausea and vomiting and health-related quality of life in women with nausea and vomiting during pregnancy
The purpose of this study is to determintion the effect of education on nutritional Guideline Ottawa on nausea and vomiting and health-related quality of life in women with nausea and vomiting of pregnancy.
The two-group clinical trial was on 60 women pregnancy from 6 to11 weeks Daneshamoz and Ahmadi health center were refer in Mashhad. To avoid data transfer between the two groups we use lottery centers for intervention and control groups are determined.
Begining DOS-21 questionnaire, the Rhodes Index will be completed for three days, if the score is 16-3 Rhodes for them, specific quality of life questionnaire completed by interview about the women with nausea and vomiting of pregnancy- .
Then,Ottawa to guide nutritional will be Presented for intervention group at During two sessions Each one 60-minute after Two week of the end we want the intervention and control groups refer to health centers and index Rhodes deliver to scholar.
Then، 2 weeks Other،For the intervention group and the control and intervention groups Rhodes index sheets give again.Checklist of Implementation Guide Ottawa Given too.
In these two weeks, twice a week, with a distance of three days, we will call for the intervention group.
After four weeks of start study، again specific quality of life questionnaire for women with nausea and vomiting of pregnancy Rhodes Index of Nausea and vomiting will be completing for three days at intervention and control groups.than two groups compare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011920716N1
Registration date:2015-04-23, 1394/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-23, 1394/02/03
Registrant information
Name
Omid Kiani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3851 5116
Email address
kianibo911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-04-19, 1394/01/30
Expected recruitment end date
2015-08-21, 1394/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on Ottawa nutritional guidelines on nausea and vomiting and health-related quality of life in women with nausea and vomiting during pregnancy
Public title
The effect of educational intervention based on Ottawa nutritional guidelines on nausea and vomiting and health-related quality of life in women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1) Signing informed consent and being Iranian and resident of Mashhad.
2) The phone number available for contact.
3) Gestational age 11-6 Week (6 weeks and 1 day to 10 weeks and 6 days) .
4) Singleton pregnancy.
5) Age 18- 35 years old.
6) have a minimum education.
7) No physically and mentally ill.
8) Not using herbal remedies to reduce nausea and vomiting.
9) In response to the tool Rhodes score of 3 to 16 win.
10) BMI is equal to or less than 30.
11) Pregnancy is required.
12) No pregnancy following assisted reproductive techniques.
13) No audio problem and no mental retardation.
14) No history of two consecutive miscarriages before pregnancy.
15) No smoking, no drugs and alcohol.
16) The history of stressful events during the last six months is not.
17) 21-DOS in response to the questionnaire score less than 10, 14, 17, respectively, in the areas of depression, anxiety and stress attend..
Exclusion criteria:
1) No tendency to continue to participate in the study.
2) Obstetric complications occurred during the study.
3) vomit that is a cause other than pregnancy.
4) Admission due to severe nausea and vomiting of pregnancy.
5) Not attending in one of the sessions
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Next to the Hoveyzeh cinema, Mashhad
City
Mashhad
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
930441
Health conditions studied
1
Description of health condition studied
Nausea and vomiting during pregnancy
ICD-10 code
O21
ICD-10 code description
Excessive vomiting in pregnancy
Primary outcomes
1
Description
nausea and vomiting pregnancy
Timepoint
Four weeks after the intervention with two-week intervals
Method of measurement
Index of Nausea and vomiting Rhodes
Secondary outcomes
1
Description
Health-related quality of life after 4 weeks of study
Timepoint
The second week until the fourth week intervals for three days
Method of measurement
Health-Related Quality of Life Questionnaire in women with nausea and vomiting of pregnancy
Intervention groups
1
Description
Intervention group:
Training Guide Nutrition Ottawa
Category
Prevention
2
Description
Control group: Routin training for obstetric care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Danesh Amooz health centers
Full name of responsible person
Mahbobeh Soltani
Street address
Farhang Square - Danesh Amooz 10 - Danesh Amooz Boulevard- Vakil Abad Boulevard
City
Mashhad
2
Recruitment center
Name of recruitment center
Ahmadi health centers
Full name of responsible person
Mahbobeh Soltani
Street address
Abu Taleb intersection- Boulevard Shahid Gharani
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences - Deputy of Research and Technology
Full name of responsible person
Mohsen Tafaghodi (Pharm.D., Ph.D.) ( Deputy of Research and Technology)
Street address
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences, Next to the Hoveyzeh cinema, MashhadIran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences - Deputy of Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Siences
Full name of responsible person
Mahbobeh Soltani
Position
MSc student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina st., Doctora cross way, Daneshgah Avenue, Mashhad
City
Mashhad
Postal code
Phone
Fax
Email
soltanim912@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Golmakani Nahid
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ibn Sina st., Doctora cross way, Daneshgah Avenue, Mashhad
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
golmakanin@mums. ac. ir
Web page address
http://www.mums.ac.ir/nurse
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Omid Kiani
Position
Student of Biostatistics
Other areas of specialty/work
Street address
School of Public Health, 18th daneshgah. Daneshgah st., Mashhad
City
Mashhad
Postal code
Phone
Fax
Email
kianibo911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)