The aim of the present study was to investigate the effectiveness of supportive counseling in reducing anxiety of pregnant women at risk of preterm labor. Population of this study was pregnant women at risk of preterm labor and conducted with the participation of 42 each group (intervention and control). They were randomly assigned in two groups. This study has two-phase survey, in the first phase anxiety questionnaire was completed by participants and in the second phase intervention was done and then the questionnaire was completed again. For preventing contamination the data were gathered every other week. Each group (control, intervention) were selected randomly for placing in which week.The inclusion criteria were, gestational age between 26-34 week , positive Nitrazine test ( based on laboratory documents), doesn’t have preterm delivery and delivery abnormal infant, history of infertility ,history of using psychotic drugs and no history of hospitalized because of mental problems, and exclusion criterion was mothers who delivered baby before completing questionnaire. Intervention was supportive counseling) (two session, each session 60 minutes in morning shift) that was conducted by clinical psychologist. The secondary outcome of this study was level of anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072823382N1
Registration date:2016-01-30, 1394/11/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Zhila Soltanahmadi
Name of organization / entity
Kerman University of Medical Sciences faculty of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 34131325219
Email address
j_soltanahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supportive counselling on the anxiety of women who are at risk of preterm birth
Public title
Effect of supportive counselling on the anxiety of women who are at risk of preterm birth
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria were, gestational age between 26-34 week , positive Nitrazine test ( based on laboratory documents), doesn’t have preterm delivery and delivery abnormal infant, history of infertility ,history of using psychotic drugs and no history of hospitalized because of mental problems, and exclusion criterion was mothers who delivered baby before completing questionnaire. Intervention was supportive counseling) (two session, each session 60 minutes in morning shift) that was conducted by clinical psychologist. The secondary outcome of this study was level of anxiety.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
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
kerman university of Medical Sciences
Street address
Islamic Republic Blve, Kerman,Iran
City
Kerman
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93/540/k
Health conditions studied
1
Description of health condition studied
preterm birth
ICD-10 code
O60.0
ICD-10 code description
Preterm labour without delivery
2
Description of health condition studied
anxiety
ICD-10 code
f30-f39
ICD-10 code description
Mood [affective] disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention and after finishing intervention
Method of measurement
standard Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Supportive Counselling/ Intervention
Category
Behavior
2
Description
No Intervention/Control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Mahdie Moghadasi
Street address
1،3،S Emam Blv, Afzalipoor Hospital, Iran, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhty
Street address
1،2، S Ebnesina, Jahad Ave, Vice Chancellor of Research
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Kerman Medical University of Medical Sciences
Full name of responsible person
Jila Soltanahmadi
Street address
1, 3, University Pardis, Razi School of Nursing and Midwifery
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Medical University of Medical Sciences
Proportion provided by this source
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
Razi Faculty of Nursing and Midwifery,Kerman University of Medical Sciences
Full name of responsible person
Zhila Soltanahmadi
Position
Instructor/Master of Midwifery
Other areas of specialty/work
Street address
3, 1, Haftbagh Blv, University Pardis , Kerman, Iran R
City
Kerman
Postal code
7616913555
Phone
+98 31325219
Fax
+98 31325218
Email
J_soltanahmadi@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi Faculty of Nursing and Midwifery Kerman University of Medical Sciences
Full name of responsible person
Zhila Soltanahmadi
Position
Master of Midwifery
Other areas of specialty/work
Street address
1,3, Hftbagh Blv, University Pardis, Razi Faculty of Nursing and Midwifery
City
Kerman
Postal code
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
J_soltanahmadi@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Razi Faculty of Nursing and Midwifery, University of Medical Sciences
Full name of responsible person
Zhila Soltanahmadi
Position
faculty Member/ Master of Midwifery
Other areas of specialty/work
Street address
1, 3, Haftbagh Blv, Razi Faculty of Nursing and Midwifery,Haft Bagh Blve,Kerman,Iran
City
Kerman
Postal code
7616913555
Phone
+98 31325219
Fax
+98 31325218
Email
J_soltanahmadi@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)