The aim of the present study was to examine for the effects of stress inoculation training (SIT) on anxiety and sleep quality of pregnant women in third trimester. Inclusion criteria were: located at week 31 or 32 of pregnancy and lack of psychiatric history, also exclusion criteria were: becoming the pregnancy as a high risk pregnancy (threatened miscarriage, bleeding, preeclampsia), preterm birth (delivery before 38 weeks of pregnancy). Among the study population (n = 436 pregnant women referred to health centers and health posts in Bushehr city), 40 subjects were selected. then they were allocated to one of the experimental and control groups by random. The experimental group subjected to 7 sessions of SIT training and the time of research was winter 2012.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031716093N1
Registration date:2014-03-17, 1392/12/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-17, 1392/12/26
Registrant information
Name
Elahe Jokar
Name of organization / entity
Shahid Bahonar University of Kerman
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 0041
Email address
jokarelahe@ymail.com
Recruitment status
Recruitment complete
Funding source
Shahid Bahonar University of Kerman
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-01-03, 1391/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Stress Inoculation Training (SIT) on Anxiety and Sleep quality of Pregnant women in third trimester
Public title
The effect of stress on anxiety and sleep in women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Having the ability and interest for taking part in the training program; located at week 31 or 32 of pregnancy; lack of participation in similar classes and methods; the lack of stress in the family in the last 3 months; a satisfying marital relationships; economic status; satisfaction sector; lack of physical illness that makes anxiety and a sleep disorder; no psychiatric history; education level degree or higher; minimum of 23 participants and a maximum of 33 years.
Exclusion criteria: By discretion of the participant or the inability to sustain in training program; becoming the pregnancy high risk pregnancy (threatened miscarriage, bleeding, preeclampsia); preterm birth (delivery before 38 weeks of pregnancy)
Age
From 23 years old to 33 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Shahid Bahonar University of Kerman
Street address
22 Bahman Blvd, Kerman
City
Kerman
Postal code
Approval date
2013-11-24, 1392/09/03
Ethics committee reference number
350/1732
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
anxiety
Timepoint
before the intervention and a week after intervention
Method of measurement
Beck Anxiety Inventory
2
Description
sleep disorder
Timepoint
before the intervention and a week after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
7 session stress inoculation training for the intervention group, which included training in muscle relaxation and challenge negative automatic thoughts and replace logical thinking, coping strategies, self-guided dialogue, learning meditation, diaphragmatic interpretation, social support
Category
Other
2
Description
The control group did not receive the intervention and questionnaires have been completed only
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Meraj Health Center
Full name of responsible person
Maryam Hydrshnas
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Bahonar Unversity of Kerman
Full name of responsible person
Elahe Jokar
Street address
22 Bahman Blvd, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Bahonar Unversity of Kerman
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
Shahid Bahonar University of Kerman
Full name of responsible person
Abbas Rahmati
Position
PH.D. in counseling / Associate Professor of Shahid Bahonar University of Kerman
Other areas of specialty/work
Street address
22 Bahman Blvd, Kerman
City
Kerman
Postal code
Phone
+98 34 1322 0041
Fax
Email
abrahmati@uk.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Elahe Jokar
Position
Master of General Psychology
Other areas of specialty/work
Street address
22 Bahman Blvd
City
Kerman
Postal code
Phone
+98 34 1322 0041
Fax
Email
jokarelahe@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Elahe Jokar
Position
Master of General Psychology
Other areas of specialty/work
Street address
22 Bahman Blvd, Kerman
City
Kerman
Postal code
Phone
+98 34 1322 0041
Fax
Email
jokarelahe@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)