Investigating the effect of rocking the newborn horizontally on the attachment behaviors of mothers with premature newborn hospitalized in the neonatal intensive care unit (NICU)
The effect of rocking the newborn horizontally on the attachment behaviors of mothers with premature newborn hospitalized in the NICU .
Design
A non-randomized clinical trial with control and intervention groups on 72 mothers with premature newborn
Settings and conduct
Location : the NICU of Shiraz Hafez Hospital ,The questionnaire related to the demographic information of mother and baby is completed by the researcher as well as the Avant attachment checklist . The intervention is done after the second day of the baby's birth. The intervention consists of rocking a calm and alert baby horizontally, half an hour before feeding, for 12 minutes a day (four times and three minutes each time) and five times a week.
The correct method of intervention is taught to the mother by the researcher in a practical way. The babies of mothers in control group only receive routine care including: cardio-respiratory monitoring, oxygen therapy, infant feeding, infant positioning, fluid therapy , phototherapy .After two weeks, the mothers of both groups complete the questionnaires again and are compared with before the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria : Mothers with a baby with a fetal age of 33-36 weeks, no need for mechanical ventilation , no chronic maternal disease and possession of the ability for skin, eye or voice contact with the baby ؛ Exclusion criteria : baby care by family members other than the mother
Intervention groups
In order to prevent the exchange of information, at first all mothers who meet the entry criteria will be selected as the control group. After the discharge of the control group, sampling of the intervention group will begin. The control group receives only routine care. The intervention group performs horizontal rocking of the baby , In addition to routine care
Main outcome variables
Attachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230312057699N1
Registration date:2023-05-13, 1402/02/23
Registration timing:prospective
Last update:2023-05-13, 1402/02/23
Update count:0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Zahra Nikbakhti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3832 2868
Email address
z.nikbakhti@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rocking the newborn horizontally on the attachment behaviors of mothers with premature newborn hospitalized in the neonatal intensive care unit (NICU)
Public title
Investigating the effect of rocking the newborn on the attachment behaviors of mothers with premature newborn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with babies with a fetal age of 33-36 weeks
Hemodynamic stability
No need for mechanical ventilation
Absence of congenital malformations
Not having a chronic illness of the mother and having skin, eye or voice contact with the newborn
Exclusion criteria:
Taking care of the baby by other family members other than the mother
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Not 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
Ethics Committee of Yazd University of Medical Sciences
Street address
Islamic Azad university Complex ,Shohadaye Gomnam Blvd , Alem Square , Safaeiye
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.SSU.REC.1402.002
Health conditions studied
1
Description of health condition studied
Caring for a premature baby
ICD-10 code
Z76.3
ICD-10 code description
Healthy person accompanying sick person
Primary outcomes
1
Description
Attachment
Timepoint
Measurement of attachment before the start of the intervention (first stage) and after two weeks have passed since the start of the intervention
Method of measurement
Avant Attachment Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention consists of rocking a calm and alert baby horizontally, half an hour before feeding, for 12 minutes a day (four times and three minutes each time) and five times a week for two weeks. The baby is hugged by the mother and gently rocked horizontally. During the non-stop horizontal rocking, every 10 seconds the baby is checked for signs of stress and if even one of the signs of stress is observed, the intervention is stopped for 15 seconds and after that, the intervention starts again. In case of repeated stress symptoms three times in a row, the intervention will be stopped in that period of time
Category
Other
2
Description
Control group: Babies receive only routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Zahra Nikbakhti
Street address
Chamran Ave
City
Shiraz
Province
Fars
Postal code
71946-34786
Phone
+98 71 3647 9531
Email
nikbakht5253@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghuei
Street address
Shahid Doctor Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
samat@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zahra Nikbakhti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No.172 , Building Radvin., 16 Alley., North Safir Blvd., Shiraz Town
City
Shiraz
Province
Fars
Postal code
7176613622
Phone
+98 71 3833 2540
Email
nikbakht5253@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Pourmovahed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
12 Ave., Jihad Blvd., Safaeiye
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
movahed446@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Nikbakhti
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No.172 , Bulding Radvin., 16 Alley., North Safir Blvd
City
Shiraz
Province
Fars
Postal code
7176613622
Phone
+98 71 3833 2540
Email
nikbakht5253@gmail.com
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available