The aim of present study is to investigate the effects of supportive programs on interest and anxiety level of mothers of infants suffering from gastrointestinal disorders.In this study 60 term infant mothers who Having no history of abnormal infant were included randomly into two control and observation groups.Before and after intervention,Koren mother-infant interest questioner was used to evaluate interest level and Eschpel Burger anxiety questioner was filled by mothers to measure anxiety level in both control and observation groups.
The supportive program in observation group,with mental and psychological aspects, started by clinical psychologist or scholar for 2 sessions of 30 minutes during 2nd- 4th courses after admission infant.During this period,some issues were explained about the importance of emotional relationship between mother and infant and the mother was prepared psychologically to accept caring role,anxiety reduction and interest to infant.Then a caring program was started by the scholar,for 2 sessions of 30 minutes during 2nd- 4th courses after infant's surgery.At this time interval,according to mother's knowledge of infant's abnormality and using training images some explanations were presented about infant's condition and booklet involving information about infant care was provided for each mother.Above mentioned items were administrated practically and in face to face method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409264617N10
Registration date:2015-02-13, 1393/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-13, 1393/11/24
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-17, 1393/09/26
Expected recruitment end date
2015-05-15, 1394/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Supportive Program on Anxiety and Attachment in Infants of Mothers With Digestive Anomalies:A Randomized Controlled Clinical Trial
Public title
The Effect of Supportive Program on Anxiety and Attachmentin Infants of Mothers With Digestive Anomalies: A Randomized Controlled Clinical Trail
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mothers of infants with absolute diagnosis of gastrointestinal abnormalities(hidden or obvious); No reception of anti-depression drugs by mothers; No alcohol consumption or smoking; Having no history of abnormal infant
Signing written consent by mother;Having knowledge of reading and writing by mother; Having no life threatening danger in infant;Not suffering from alcoholic infant syndrome. Exclusion criteria Infant’s death or release during study time; Transferring infant to ICU; No tendency of mother to continue study.
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz
City
Tabriz
Postal code
5138947979
Approval date
2014-11-09, 1393/08/18
Ethics committee reference number
93123
Health conditions studied
1
Description of health condition studied
Digestive Congenital Anomalies
ICD-10 code
Q38-Q45
ICD-10 code description
Other congenital malformations of the digestive systems
Primary outcomes
1
Description
Mother's Anxiety
Timepoint
After and Before
Method of measurement
Spilberger of Self Evaluation Qustionnaire
2
Description
Attachment
Timepoint
Befor and After
Method of measurement
Maternal Attachment Inventory (MAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: support program that includes psychological support through clinical psychologist during the second and fourth days of the meeting for 30 minutes after birth in hospital admissions of children will be done. The second phase of support by the researcher during two 30-minute sessions on two consecutive days after surgery research at the neonatal unit will be done. At the First session about kind of anomalies and second meeting of the in newborn care based on practical, face-to-face training will be given.
Category
Prevention
2
Description
Control group: This group received usual care on the part of the psychologist and researcher did not receive supportive care. After completion of data collection to support their educational booklets will be at their disposal.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Educational Center Affiliated Medical Sciences University of Tabriz;Iran
Full name of responsible person
Masomeh Janetdoust
Street address
Next to the Pharmacy Mehan;Sheshgelan Street;Tabriz;Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research,Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Research Department,Central Building,Golgasht,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Alehe Seyyedrasoli
Position
Ms, Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz,Iran
City
Tabriz
Postal code
5138947-977
Phone
+98 914 110 6684
Fax
+98 41 3479 6969
Email
seyyedrasooly@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Mahnaz Jabraeili
Position
MS,Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Shariati South Street,Tabriz,Iran
City
Tabriz
Postal code
5138947-977
Phone
+98 34796770
Fax
+98 41 1479 6969
Email
Jabraeilim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Soraya Heykalabadi
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shariati South Street, Tabriz, Iran
City
Tabriz
Postal code
5138947-977
Phone
+98 41 1479 6770
Fax
+98 41 1479 6969
Email
hony.abadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)