The purpose of this study was to investigate the effect of behavior therapy on nausea, gagging and vomiting in pregnancy. 50 pregnant women referred to Imam Khomeini Hospital and Touba Specialized Clinic in the Sari city , at 6-12 weeks of gestational age, moderate and severe nausea and vomiting complaints and single pregnancy were enrolled and non-randomly assigned to the intervention and control groups. Hospitalized mothers, mothers with digestive disorders and thyroid disorders, as well as mothers with high risk pregnancies were not included in the study. Behavioral therapy sessions were conducted for the intervention group in 6 sessions of 50 minutes (for 2 weeks), in which techniques such as self-monitoring, relaxation, stimulant control, and systematic desensitization to mothers were taught. Study was not blinded. The PUEQ questionnaire was filled out by subjects for measuring nausea and vomiting and gagging immediately and 1 month after intervention.
Outcome variables: Duration of nausea, vomiting frequency, gagging frequency
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017090322609N2
Registration date:2017-11-08, 1396/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-08, 1396/08/17
Registrant information
Name
Zohre Shahhosseini
Name of organization / entity
Mazandaran Univercity of Medical Science, Nasibe School Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.shahhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Behavior Therapy on Nausea, Gagging, and Vomiting in Pregnant Women Under 12 Weeks of gestational age: A Clinical Trial
Public title
Effect of behavioral therapy on nausea and vomiting in pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Satisfaction to participate in the study; Moderate and severe nausea and vomiting, according to Modified Pregnancy Unique Quantification of Emesis (PUQE) Score; 6-12 weeks pregnancy; Single pregnancy; Reading and writing literacy.
Exclusion criteria:The history of receiving any psychotherapy in the past 6 months; molar pregnancy; Digestive disorders such as gastric ulcer and duodenal ulcer; mothers with high risk pregnancies such as spotting and bleeding; Mothers who are Candidate for Cercelag's; Major psychiatric disorder such as depression and anxiety; hospitalized pregnant women; hearing impairment; receiving other complementary therapies for the treatment of nausea and vomiting (herbal remedies such as ginger, acupressure, acupuncture).
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not 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
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences، Beginning of Basij Highway، Juybar Tree Ways، Sari، Mazanran
City
Sari
Postal code
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.MAZUMS.REC.1396.3173
Health conditions studied
1
Description of health condition studied
Nausea and vomiting in pregnancy
ICD-10 code
O21
ICD-10 code description
Excessive vomiting in pregnancy
Primary outcomes
1
Description
Nausea, Vomiting and Gagging in Pregnancy
Timepoint
Pre-intervention, Immediately and 1 Month after intervention
Method of measurement
Modified Pregnancy Unique Quantification of Emesis (PUQE) Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 sessions of behavior therapy for 2 weeks (each session for 50 minutes) are arranged for the intervention group, and techniques such as self-monitoring, relaxation, stimulant control, systematic desensitization to pregnant women are trained.
Category
Behavior
2
Description
Control group: Getting routine pregnancy care, including common medications for the control of nausea and vomiting during pregnancy (if prescribed by a doctor)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Azam Emamisahebi
Street address
Imam Khomeini Hospital، Amir Mazandarani Avenue، Sari، Mazandaran
City
Sari
2
Recruitment center
Name of recruitment center
Touba Specialized Clinic
Full name of responsible person
Azam Emamisahebi
Street address
Touba Specialized Clinic، Former Medical Faculty، Khazar Boulevard، Sari، Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ravanbakhsh Esmaeili
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences، Moalem Square، Moalem Avenue، Sari، Mazandaran
City
Sari
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Azam Emamisahebi
Position
Master
Other areas of specialty/work
Street address
Nasibe Nursing and Midwifery Faculty، Vesal Shirazi Avenue،Sari، Mazandaran
City
Sari
Postal code
Phone
+98 11 3311 0430
Fax
Email
Emami.azam371@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Shahhosseini
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Nasibe Nursing and Midwifery Faculty، Vesal Shirazi Avenue، Sari، Mazandaran
City
sari
Postal code
Phone
+98 11 3337 4750
Fax
Email
zshahhosseini@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Azam Emamisahebi
Position
Masters
Other areas of specialty/work
Street address
Nasibe Nursing and Midwifery Faculty، Vesal Shirazi Avenue، Sari، Mazandaran
City
Sari
Postal code
Phone
+98 11 3311 0430
Fax
Email
Emami.azam371@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)