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The effect of nursing support program on stress disorder tolerance of mothers of premature babies hospitalized in neonatal intensive care unit

Protocol summary

Study aim
Determining the nursing support program on the distress tolerance of mothers of premature babies hospitalized in the neonatal intensive care unit
Design
The current study is an intervention type that is based on 84 samples (42 people in the intervention group and 42 people in the comparison group).
Settings and conduct
Mothers with premature babies admitted to the neonatal intensive care unit in Bent Al-Hoda Hospital in Bojnoord.
Participants/Inclusion and exclusion criteria
Entry requirements: they were literate, had a premature baby of 28 to 30 weeks and were hospitalized for at least one week. Not having a definite diagnosis of depression, not taking antidepressants and any narcotic and psychoactive drugs, and not having a history of hospitalization of a premature baby in the neonatal intensive care unit; Conditions for non-entry: death, discharge or illness of the baby and unwillingness of the mother to continue cooperation, physical manifestation of congenital disease in the baby, discharge earlier than 14 days of the baby, twin babies, and the mother's non-participation in at least 5 training sessions
Intervention groups
Mothers referred to the neonatal intensive care unit of Bent Al-Hadi Hospital in Bojnord, who were trained by the researcher during 8-10 sessions in 4 weeks (2 sessions per week on even days in the morning and evening shifts, for a total of 45 minutes per session) They were supported by nursing. Individual profile questionnaire and emotional distress tolerance questionnaire (DTS) are completed once before training in both control and intervention groups.
Main outcome variables
nursing support; Tolerate distress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230126057235N2
Registration date: 2023-11-08, 1402/08/17
Registration timing: registered_while_recruiting

Last update: 2023-11-08, 1402/08/17
Update count: 0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Narges Sefidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 6553
Email address
a.abbaszadeh@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-12, 1402/07/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nursing support program on stress disorder tolerance of mothers of premature babies hospitalized in neonatal intensive care unit
Public title
The effect of nursing support program on stress disorder tolerance of mothers of premature babies hospitalized in neonatal intensive care unit
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers with babies hospitalized in the neonatal intensive care unit, who were literate, had a premature baby of 28 to 30 weeks, were hospitalized for at least one week, did not have a definite diagnosis of depression, did not take antidepressants, did not take any narcotics and psychotropic drugs, had no history Admitting a premature baby to the neonatal intensive care unit
Exclusion criteria:
Death, discharge or illness of the baby, mother's unwillingness to continue to cooperate in the study of physical manifestations of congenital disease in the baby, discharge earlier than 14 days of the baby, twin babies, mother's non-participation in at least 5 training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is the coin flip method in such a way that one of the study groups is considered to be the lion and the other group is considered to be the line, and based on the desired sample size, the same number of coins are tossed and people are assigned to two groups. They find it by accident
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to avoid the effect of the intervention on the control group and homogenize the two groups, the first group was selected by lottery and the control group was selected as the first group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Dolat Blvd, Central Building of North Khorasan University of Medical Sciences, Bojnord
City
bojnurd
Province
North Khorasan
Postal code
94137436941
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR.NKUMS.REC.1402.098

Health conditions studied

1

Description of health condition studied
Premature infants
ICD-10 code
P07.3
ICD-10 code description
Preterm [premature] newborn [other]

Primary outcomes

1

Description
Enduring the distress of mothers with premature babies
Timepoint
Mothers were given nursing support training by the researcher during 8-10 sessions in 4 weeks (2 sessions per week on even days in the morning and evening shifts, for a total of 45 minutes in each session).
Method of measurement
Personal profile questionnaire and emotional distress tolerance questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Mothers were given nursing support training by the researcher during 8-10 sessions within 4 weeks (2 sessions per week on even days in the morning and evening shifts, for a total of 45 minutes per session).
Category
Behavior

2

Description
Control group: They receive routine care, including regular training of the department, and they complete the center's routine training once before and once at the end of the study, the distress tolerance questionnaire.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bent Al-Hadi Bojnord Hospital
Full name of responsible person
Narges sefidi
Street address
Art street
City
Bojnurd
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Bahram Bibak
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Hojat Allah ehtesham Manesh
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dolat Blvd, Central Building of North Khorasan University of Medical Sciences, Bojnord
City
Bojnurd
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hojat Allah ehtesham Manesh
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Art street
City
Bojnurd
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hojat Allah ehtesham Manesh
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
94137436941
Phone
+98 58 3223 6551
Email
Sepidin@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Nursing support and distress tolerance
When the data will become available and for how long
6 months
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Print the article
From where data/document is obtainable
sepidin@yahoo.com narges sefidi
What processes are involved for a request to access data/document
After analyzing the data and printing the article
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