Evaluation the effect of training attachment behavior to mother on physiological status and response to behavior preterm infants in the neonatal intensive care unit depend to shiraz university of medical sciences in 2013
1) Objectives: evaluation the effect of training attachment behavior to mother on physiological status and response to behavior preterm infants in the neonatal intensive care unit. 2) Design: single-blind randomized clinical trial. 3) Setting and conduct: 64 premature infants who are eligible for the study are divided by the randomized sampling allocation into two experimental and control groups. The infants in the experimental group training attachment behavior to mother using the infant and the infants in the control group the method of training attachment by nurses unit. Body temperature, heart rate, respiratory rate, and blood oxygen saturation are measured. Physiological parameters to three times are measured: the first time half an hour before the exit to bed, 2: during intervention 3: half hour after entering to bed. Response behavior 2 hours before exit and 2 hours after entrance are checked by a nurse who is kept uninformed about the study and its assumptions. To record the behavioral responses, the infant's face is captured in close-up during the after intervention and before intervention. The films are interpreted by an observer without knowledge of the intervention type. Finally, the changes in the physiological and behavioral parameters are compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070818406N2
Registration date:2014-08-31, 1393/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-31, 1393/06/09
Registrant information
Name
Sahra Zendeh Zaban
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 4525 2851
Email address
zendehzaban@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of training attachment behavior to mother on physiological status and response to behavior preterm infants in the neonatal intensive care unit depend to shiraz university of medical sciences in 2013
Public title
Evaluation the effect of training attachment behavior to mother on physiological status and response to behavior preterm infants in the neonatal intensive care unit depend to shiraz university of medical sciences in 2013
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestational age of 32–36 weeks; postnatal age of 7-30 days; weight 1500-2500 grams; not using sedatives and short- or long-acting skeletal muscle relaxant drugs; not having substance abuse issues and no sedative drug use by the mother; no major congenital, chromosomal or neurological abnormalities;stability of physiological parameters in the infant; ability for oral breast feeding, and keep in incubator.
Exclusion criteria: need to ventilator in the infant; need to oxygen therapy; inability for oral breast feeding; using sedatives and short- or long-acting skeletal muscle relaxant drugsز; parents' unwillingness to continue cooperating in research.
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
zand
City
shiraz
Postal code
Approval date
2014-06-30, 1393/04/09
Ethics committee reference number
93-7057
Health conditions studied
1
Description of health condition studied
Preterm infants
ICD-10 code
P07.3
ICD-10 code description
Prematurity NOS
Primary outcomes
1
Description
Temperature
Timepoint
First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed
Method of measurement
Thermometer
2
Description
Heart rate
Timepoint
First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed
Method of measurement
Pulse oximetry
3
Description
Blood oxygen saturation
Timepoint
First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed
Method of measurement
Pulse oximetry
4
Description
Respiration rate
Timepoint
First time half an hour before the exit from the bed, second time during intervention and third time half hour after entering to the bed
Method of measurement
Observation
5
Description
Behavioral responses
Timepoint
First time 2 hours before exit and second time 2 hours after entering to the bed(incubator)
Method of measurement
Video camera
Secondary outcomes
empty
Intervention groups
1
Description
For the infants in the experimental group, training attachment behavior to mothers' of the infants are performed by the researcher. Body temperature, heart rate, respiratory rate, and blood oxygen saturation are measured. Physiological parameters to three times are measured: the first time half an hour before the exit to bed, 2: during intervention 3: half hour after entering to bed. Response behavior 2 hours before exit and 2 hours after enter checked by a nurse who is kept uninformed about the study and its assumptions. To record the behavioral responses, the infant's face is captured in close-up during the after intervention and before intervention. The films are interpreted by an observer without knowledge of the intervention type. Finally, the changes in the physiological and behavioral parameters of the
Category
Prevention
2
Description
In the control group the method of training attachment are performed by nurses. Body temperature, heart rate, respiratory rate, and blood oxygen saturation are measured. Physiological parameters to three times are measured: the first time half an hour before the exit to bed, 2: during intervention 3: half hour after entering to bed. Response behavior 2 hours before exit and 2 hours after enter checked by a nurse who is kept uninformed about the study and its assumptions. To record the behavioral responses, the infant's face is captured in close-up during the after intervention and before intervention. The films are interpreted by an observer without knowledge of the intervention type. Finally, the changes in the physiological and behavioral parameters of the
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Sahra Zendehzaban
Street address
Hafez hospital, Abiverdi Street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, shiraz 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
Shiraz University of Medical Sciences - Hazrat-e-Fatemeh Nursing and Midwifery Faculty
Full name of responsible person
Sahra Zendeh Zaban
Position
Neonatal Intensive Care Nursing Master of Science Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
zendehzaban@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences - Hazrat-e-Fatemeh Nursing and Midwifery Faculty
Full name of responsible person
Mitra Edraki
Position
Pediatric Nursing MS, Faculty member
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
Mitraedraki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sahra Zendeh Zaban
Position
Neonatal Intensive Care Nursing Master of Science Student
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
Fax
Email
zendehzaban@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)