The effect of cognitive-behavioral counseling on the mental health of mothers who have premature infants hospitalized in neonatal intensive care unit of Hazrat Zeinab Shiraz city 2016. Hospital in
Determining the effect of cognitive-behavioral counseling on mental health of mothers with premature infants admitted to Neonatal intensive care unit of Zainab Hospital in Shiraz
Design
The research method was quasi-experimental, consisting two control and trial groups. The population consisted of 50 (25 in the intervention and 25 in the control group) mothers with premature infants who had inclusion criteria who were randomly selected. inclusion criteria include mothers whose infants have been hospitalized due to prematurely for at least 3 weeks, and the mother doesn't suffer any mental and physical disorders, didn't receive counseling services before and had no history of preterm infant births.
Settings and conduct
After a pretest, cognitive behavioral group counseling sessions were held in six sessions of 45 minutes, two sessions a weeks for the mothers in the intervention group who scored 23 and more in the Goldberg & Hiller Mental Health Questionnaire; and a posttest was held after the completion of the counseling. The control group with cited criteria have passed the pre-test and post-test in a three-week interval without any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria include mothers whose infants have been admitted in NICU due to prematurity for least three weeks, and the mother doesn't suffer any mental and physical disorders, didn't receive counseling services before and had no history of preterm infant births. Exclusion criteria are the baby's discharge, death died or transfer to another hospital
Intervention groups
Intervention as cognitive-behavioral group counseling for 6 sessions, each session 45 minutes, twice a week
Main outcome variables
The counseling has had a positive impact, although the exact results are not yet clear and the data is in the analysis phase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170611034452N2
Registration date:2017-12-03, 1396/09/12
Registration timing:retrospective
Last update:2017-12-03, 1396/09/12
Update count:0
Registration date
2017-12-03, 1396/09/12
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Kerman University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral counseling on the mental health of mothers who have premature infants hospitalized in neonatal intensive care unit of Hazrat Zeinab Shiraz city 2016. Hospital in
Public title
The effect of cognitive-behavioral counseling on the mental health of mothers who have premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers of premature infants hospitalized at neonatal intensive care unit for at least 3weeks, without any physical or psychological problems, without premature infant born, receiving no consulting service
Exclusion criteria:
the infant has entered to NICU from another hospital or be died/discharge before the end of the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
50individuals were selected using simple random sampling and divided into control and intervention group, each with 25 individuals. the analysis results would be analyzed using SPSS.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences & Health Services
Street address
Kerman-first of the Haft Bagh Allavi - Pardis of Kerman Un
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.KMU.REC.1395.970
Health conditions studied
1
Description of health condition studied
Mental Health
ICD-10 code
F90- F98
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
Description
Cognitive behavioral counseling
Timepoint
Six sessions of 45 minutes in three weeks
Method of measurement
Goldberg & Hiller Questionnaire
Secondary outcomes
1
Description
Mental health
Timepoint
Before and after cognitive behavioral counseling in the intervention group and without intervention intervention in the control group
Method of measurement
Goldberg & Hiller Questionnaire
Intervention groups
1
Description
Intervention in the form of cognitive-behavioral group counseling was conducted in mothers with a mental health score of 23 and above twice a week for 45 minutes during the three weeks in the intervention group. In the control group, without consulting, w
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zeynab Hospital in Shiraz
Full name of responsible person
Elaheh samani
Street address
Shiraz, Defaee Moghadas Square, Hazrat Zeynab Training Center City
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3843 9873
Email
zeinabhp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Kerman University of Medical Sciences
Full name of responsible person
Atefeh ahmadi
Street address
Kerman-first element of the Haft Bagh Allavi - Pardis of Kerman Un
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kmsrc@googlegroups.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
proffessor asistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman-first of the Haft Bagh Allavi - Pardis of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Fax
Email
a.ahmadi@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh ahmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman-first element of the Haft Bagh Allavi - Pardis of Kerman Un
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Fax
Email
a.ahmadi@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh ahmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kerman-first element of the Haft Bagh Allavi - Pardis of Kerman Un
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Fax
Email
a.ahmadi@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available