The aim of this study was to determine the effect of telephone support on health-related quality of life in women with nausea and vomiting of pregnancy. This clinical trial was done on 64 primiparous women who referred to the selected health care centers in Mashhad city with gestational age 6-10 weeks. Modified Pregnancy-Unique Quantification of Emesis and Nausea questionnaire and Visual Analog stress Scale For eligible women with diagnosed of nausea and vomiting of pregnancy by nausea and vomiting protocol in "Safe Motherhood country program booklet" through interview was completed. If there is mild to moderate nausea and vomiting, necessary educational actions on the basis of the "checklist of patient education with pregnancy nausea and vomiting" was performed by researchers. This checklist according to nausea and vomiting protocol in "Safe Motherhood country program booklet" was prepared by the researcher. Demographic and obstetric questionnaire was completed for units of study (nausea and vomiting in pregnancy, quality of life questionnaire and Multidimensional Scale of Perceived Social Support). Units of study were allocated randomly into control (30 patients) and experimental group (30 patients). In the intervention group, telephone support was twice a week to four weeks, and each time was 15-20 minutes. Telephone support was includes advice on modification of diet and lifestyle, reduce fatigue and improve psychological states of pregnant. Control group was usual care. Again after four weeks, Modified Pregnancy-Unique Quantification of Emesis and Nausea questionnaire, nausea and vomiting in pregnancy quality of life questionnaire, multidimensional Scale of Perceived Social Support and Visual Analog stress Scale were complemented by face to face.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012316326N1
Registration date:2014-05-30, 1393/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-30, 1393/03/09
Registrant information
Name
Narjes Abbaszadeh
Name of organization / entity
Faculty of nursing and midwifery of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 79 1333 1199
Email address
abbaszn901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-10-02, 1392/07/10
Expected recruitment end date
2014-02-09, 1392/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of telephone support on health-related quality of life in women with nausea and vomiting of pregnancy
Public title
The effect of telephone support on health-related quality of life in nausea and vomiting of pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 6-10 week, First pregnancy, Having mild or moderate nausea and vomiting by Modified Pregnancy-Unique Quantification of Emesis and Nausea questionnaire, Access to telephone, Would like to participate in the study, Lack of medical disease in pregnancy, Lack of Hearing impairment , Not use anti-nausea drug treatments or alternative medicine during the past week
Exclusion criteria: obtain Score more than seven of the visual Analog stress scale, Having symptoms of threatened abortion
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Building Qureshi, Daneshgah Avenue
City
Mashhad
Postal code
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
research/920084/1/101
Health conditions studied
1
Description of health condition studied
Health-related quality of life in nausea and vomiting of pregnancy
ICD-10 code
O21
ICD-10 code description
Excessive vomiting in pregnancy
Primary outcomes
1
Description
Health-related quality of life in nausea and vomiting of pregnancy
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Nousea and vomiting in pregnancy quality of life questionnaire
Secondary outcomes
1
Description
Nausea and vomiting of pregnancy
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Modified Pregnancy-Unique Quantification of Emesis and Nausea questionnaire
Intervention groups
1
Description
Control group received just routine care
Category
N/A
2
Description
In the experimental group, 15-20 minutes phone provided twice a week for four weeks. Telephone support, included offering measures to improve diet and life style as well as actions for reducing fatigue and enhancing psychological well- being
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers no.1, 2, 3, 5 and Samen
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Building Qureshi, Daneshgah Avenue
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
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
Faculty of Nursing and Midwifery of Mashhad
Full name of responsible person
Zahra Abedian
Position
Master of midwifery
Other areas of specialty/work
Street address
Crossroads Doktora, Ibn-Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
abedianz@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty Nursing and Midwifery of Mashhad
Full name of responsible person
Zahra Abedian
Position
Master of midwifery
Other areas of specialty/work
Street address
Crossroads Doktora, Ibn-Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
abedianz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Nursing and Midwifery of Mashhad
Full name of responsible person
Narjes Abbaszadeh
Position
Student of Msc
Other areas of specialty/work
Street address
Cross Doctor, Ibn-Sina Street
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
abbaszn901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)