Investigating the effect of maternal support through telenursing on maternal attachment and quality of life in premature infants under invasive ventilation
Determining and comparing the effect of maternal support through telenursing on maternal attachment and quality of life in premature infants under invasive ventilation in control and intervention groups.
Design
The clinical trial has two control and intervention groups, the sampling method is accessible and simple random, without blinding, on 40 premature babies
Settings and conduct
The research will be conducted with the participation of 40 mothers of premature babies between 26 and 34 weeks who were under ventilator in Qaim and Imam Reza Hospital of Mashhad. Mothers enter the study on the day of discharge, mothers in the intervention group receive the telenursing program for 4 weeks. Mothers in the control group will receive routine care. Data collection will be done on day 0 and day 30 after discharge, which includes attachment and quality of life questionnaires and scoring based on the mother's answers.
Participants/Inclusion and exclusion criteria
Entry criteria: mother's age between 18 and 35 years, mother's ability and access to a telephone, having a premature baby between 26 and 34 weeks who is ventilated for more than three days, discharge order.
Exclusion criteria: the baby has an anomaly, the baby has a history of surgery, the baby's mother is addict, the baby is under invasive ventilation.
Intervention groups
Intervention group: mothers of preterm infants undergoing invasive ventilation with inclusion criteria who receive the intervention of telenursing support over the phone.
Control group: mothers of invasively ventilated preterm infants with inclusion criteria receiving routine care
Main outcome variables
Improving the quality of life and attachment in mothers of babies under invasive ventilation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230708058717N1
Registration date:2023-12-17, 1402/09/26
Registration timing:prospective
Last update:2023-12-17, 1402/09/26
Update count:0
Registration date
2023-12-17, 1402/09/26
Registrant information
Name
mahsa hesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 6554
Email address
hesarim4012@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of maternal support through telenursing on maternal attachment and quality of life in premature infants under invasive ventilation
Public title
Investigating the effect of maternal support through telenursing on maternal attachment and quality of life in premature infants under invasive ventilation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mother's age between 18 and 35 years
Firstborn
Mother with no known psychiatric illness
The mother's ability and access to a landline or mobile phone
Having premature babies between 26 and 34 weeks who have been ventilated for more than three days
discharge order
Exclusion criteria:
Mother's unwillingness to cooperate in the study
Mother's addiction
Having a history of surgery in a baby
A newborn without obvious congenital anomalies
Age
From 182 days old to 238 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The random block method with a block size of 4 will be used considering that the final sample size is 20 people in each group and a total of 40 people considering the dropout rate. The start of the study will be provided to the researcher.
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
School of Nursing and Midwifery - Mashhad University of Medical Sciences
Street address
Azadi Square, Ferdowsi University, Khorazmi Building
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Approval date
2023-11-16, 1402/08/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.100
Health conditions studied
1
Description of health condition studied
Special conditions that occur in the perinatal period. Including the birth of a baby before the 37th week of intrauterine pregnancy.
ICD-10 code
O60
ICD-10 code description
Preterm labor
Primary outcomes
1
Description
Maternal attachment score in preterm infants with aggressive ventilation
Timepoint
Day zero and thirty after discharge
Method of measurement
Attachment questionnaire
Secondary outcomes
1
Description
Quality of life score in mothers with premature babies under invasive ventilation
Timepoint
On day zero and thirty after discharge
Method of measurement
Quality of life questionnaire
Intervention groups
1
Description
Intervention group: the mothers under study will enter the study on the day of discharge from the hospital, and a summary of the baby's file will be received for planning. Mothers in the intervention group receive the telenursing program for 4 weeks. The telenursing program is implemented based on the documented care plan that includes two areas of baby care and mother care.
Category
Other
2
Description
Control group: the mothers under study will enter the study on the day of discharge from the hospital and the summary of the baby's file will be received for planning. Mothers in the control group will receive routine care, i.e. education at the time of discharge.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neonatal Special Care Department of Ghaem Hospital in Mashhad
Full name of responsible person
Mahsa Hesari
Street address
Ghaem Hospital: Dr. Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۹۱۹۹-۹۱۷۶۶
Phone
+98 51 3845 3239
Email
b.ghaem@mums.ac.ir
Web page address
https://quaem.mums.ac.ir
2
Recruitment center
Name of recruitment center
Neonatal Special Care Department of Imam Reza Hospital, Mashhad
Full name of responsible person
Mahsa Hesari
Street address
Ibn Sina St. - edge of Imam Reza Square
City
Masshad
Province
Razavi Khorasan
Postal code
۹۱۳۷۶۳۵۵۶۷
Phone
+98 51 3854 3031
Email
b.emamreza@mums.ac.ir
Web page address
https://emamreza.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Majid Ghayur
Street address
Vakil Abad Blvd., Campus, Science Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Hesari
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vakil Abad Blvd., Campus, Science Blvd
City
Mashhad
Province
North Khorasan
Postal code
9177948974
Phone
+98 51 3859 1511
Email
Hesarim4012@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aramesh Rezaian
Position
the coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad, Vakil Abad Boulevard, Pardis
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051338591511
Email
RezaeianA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Hesari
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Vakil Abad Blvd., Campus, Science Blvd
City
Mashhad
Province
North Khorasan
Postal code
9177948974
Phone
+98 51 3859 1511
Email
Hesarim4012@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD