Protocol summary

Summary
Premature infants compared to natural ones experience several problems, so it is inevitable to hospitalize them in Neonate' Intensive Care Unit (NICU). After, hospitalizing the infants, mothers suffer a high degree of stress. On one hand, inefficient coping leads to a disordered infant-mother attachment. Therefore, supportive programs are needed to support these mothers during the period of hospitalization. This study was implemented in form of a randomized experimental design over 70 mothers with premature infants in Ommolbanin hospital, Mashhad, Iran. In order to avoid exchanging information between the two groups, first, control group was randomly assigned. Having selected the sample, sample selection was stopped for three weeks till mothers participating in the study were discharged from the hospital. Then participants for experimental group were selected. Criteria for enrollment in the study: Age over 18 years, the ability to read and write, babies who were less than 37 weeks of gestational age, or weighed less than 2500 grams. Criteria for discharging: Infant discharging before the program completion, mothers' dissatisfaction to continue. Treatment included four stages: Stage 1: 2 to 4 days after infant hospitalization Stage2: 2 to 4 days after the first stage Stage3: 1 to 3 days before discharging Stage 4: 1 week after discharging In every stage, in the absence of the researcher, the mother listened to an audio file containing information regarding that stage, for 15 minutes. At the same time this information was provided for the mother in the form of a booklet to use during the time of listening. Also, there was a workbook related to that stage at the end of every booklet and mother was required to complete. The completed version was provided for the research.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014101519545N1
Registration date: 2014-11-23, 1393/09/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-23, 1393/09/02
Registrant information
Name
Azam Momenizadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5224 7033
Email address
momeniza911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2014-05-06, 1393/02/16
Expected recruitment end date
2014-10-05, 1393/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of Creating Opportunities for Parent Empowerment (COPE) program on coping mechanism and mother–preterm infants bonding hospitalized in NICUs.
Public title
Evaluating the effectiveness of Creating Opportunities for Parent Empowerment (COPE) program on coping mechanism and mother–preterm infants bonding
Purpose
Supportive
Inclusion/Exclusion criteria
All mothers older than 18 years of age and who could read and speak Persian; who had not had another infant admitted to the NICU; who According to information obtained from the medical records had not had any; physical illness disrupts daily activities and specific medical problems associated with delivery of as well as mental illness; neurological problems that lead to drug use is clearly. and whose infants met the following criteria were eligible for participation: gestational age of under 37 weeks inclusive; birth weight of less than 2500 grams; no problem is life threatening ; anticipated survival; and There is no physical abnormalities ; Exclusion criteria, mothers whose infants discharged from hospital before the program ends and mothers whose neonate died and. Mother's unwillingness to cooperation
Age
To 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Parental Empowerment Program (COPE) a educational-behavioural intervention based on the theory of self-regulation and Control is designed by Melyk, in 2001 for parents parents of premature infants

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research, Mashhad University of Medical Sciences
Street address
Resarch Assistance, Building Qureshi, Daneshgah Street, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
3316-913791
Approval date
2014-04-29, 1393/02/09
Ethics committee reference number
research/922086/1/827

Health conditions studied

1

Description of health condition studied
preterm infant
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants

Primary outcomes

1

Description
Coping Strategies with Stress
Timepoint
2 to 4 day after infant hospitalization and 1 days before discharging Stage
Method of measurement
Brief COPE Questionnaire

Secondary outcomes

1

Description
lenght of stay
Timepoint
The wole of hospitalization from admission day until discharge
Method of measurement
The wole of hospitalization from admission day until discharge

2

Description
Rate of readmission
Timepoint
One mounth after discharge from haspital
Method of measurement
Call contact after discharge from haspital

3

Description
Mother–infant bonding
Timepoint
1 days before discharging
Method of measurement
Questionnaire Avant

Intervention groups

1

Description
Treatment included four stages: Stage 1: 2 to 4 days after infant hospitalization Stage2: 2 to 4 days after the first stage Stage3: 1 to 3 days before discharging Stage 4: 1 week after discharging In every stage, in the absence of the researcher, the mother listened to an audio file containing information regarding that stage, for 15 minutes. At the same time this information was provided for the mother in the form of a booklet to use during the time of listening. Also, there was a workbook related to that stage at the end of every booklet and mother was required to complete. The completed version was provided for the research.
Category
Behavior

2

Description
In the control group, the intervention not be; 2_4 day after admitted after infant brife cope questionnaire completed by the mother ; then baby's mother attachment 1 day before discharge by; researchers help blind study assessed ; coping strategies questionnaire was also being used by mother completed
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ommolbanin hospital
Full name of responsible person
Soheila Karbandi
Street address
Ayatollah Behjat Avenue, Ayatollah Behjat 16th, Mashhad-Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Resarch Assistance, Building Qureshi, Daneshgah Street, Doctora Crossroads, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
AZAM Momenizadeh
Position
MSc in Nursing, Neonatal Intensive Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
City
Mashhad
Postal code
iran
Phone
+98 51 5224 7033
Fax
+98 917 125 9335
Email
momeniza911@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Karbandi
Position
MSc Nursing, Faculty member of School of Nursing and Midwifery, Mashhad
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Doctora Crossroads, Mashhad Mashhad
City
Mashhad
Postal code
iran
Phone
+98 518591511
Fax
+98 38548048051
Email
KarbandiS@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam Momenizadeh
Position
MSc in Nursing, Neonatal Intensive Care
Other areas of specialty/work
Street address
Mashhad
City
School of Nursing and Midwifery, Doctora Crossroads, Mashhad
Postal code
iran
Phone
+98 51 5224 7033
Fax
Email
momeniza911@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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