1)Objectives, this study conducted as effectiveness of cognitive – behavioral group counseling on pregnancy’s worries and stress in pregnant women.2)Design, this is a randomized clinical trial without blinding.The sample size will be 70 pregnant women in multi selected center.3) Setting and conduct, Data were collected using a pregnancy-specific stress questionnaire( PWSQ)4) Participants (including major eligibility criteria),Women in the study were 18 to 35 years old with at least education diploma and without history of mental illness5)Intervention contain group counseling and 6)main outcome measures (primary and secondary outcome variables) is pregnancy’s worries and stress in pregnant women
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052527728N2
Registration date:2016-06-27, 1395/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University Medical Sciences and Health Services
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of cognitive – behavioral group counseling on pregnancy’s worries and stress in pregnant women
Public title
Effectiveness of group counseling on pregnancy’s worries and stress in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian women; 18 to 35 years old; 20 to 32 week by LMP or Sonography under 12 week; single pregnancy; Primi Gravida; at least Diploma; Women with stress by pregnancy"s worries and stress questionnaire; Lack of mental illnesses and depression disorders According to patient; Do not use antidepressants and anti anxiety and anti stress drugs Exclusion criteria: Unwillingness to continue participation in the study; If they have unfortunate accidents in the past 6 months for example ( Death of a spouse, a relative preference ، Divorce، The imprisonment of husband..)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block sampling with random numeral
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz.University of Medical Sciences
Street address
Alborz University Of Medical Saiences,Karaj,IRAN
City
Karaj
Postal code
561-31452
Approval date
2016-05-08, 1395/02/19
Ethics committee reference number
Abzums.Rec.1395,19
Health conditions studied
1
Description of health condition studied
cognetive behaviour disorder
ICD-10 code
F43.0
ICD-10 code description
A transient disorder that develops in an individual without any other apparent mental disorder in response to exceptional physical and mental stress and that usually subsides within hours or days. Individual vulnerability and coping capacity play a role i
Primary outcomes
1
Description
Pregnancy's worries and stress
Timepoint
Before intervention _ Immediately after the intervention -two weeks after intervention
Method of measurement
Quetionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention1: in case group, In addition to the Routine consultation, they have 6 session cognitive behavioral treatment. in2 session (90 minute) in week
Category
Behavior
2
Description
Control group: educational package with routine consultant.