Protocol summary

Summary
The purpose of this study was to evaluate the effectiveness of Creating Opportunities for Parent Empowerment (C.O.P.E) program on psychological outcomes and participation of mothers who have preterm infants. Method: Randomized, single blind controlled without placebo, in more than one centre in a city, phase 2-3 trial. Main inclusion criteria: older than 18 years of age, ability to read and speak Persian, infants with: gestational age of 26 to 34 weeks, birth weight of less than 2500 grams, singleton birth, no severe handicapping conditions. Main exclusion criteria: mothers who left the program and did not come back to hospital for more than 4 days. Sample size: 90 mothers Intervention, time and primary outcomes: First phase was hold 2-4 days and second phase 4-8 days after NICU admission. Before every intervention phase, assessments tools were completed and the last evaluation was done 6-12 days post NICU admission. In each session mothers listened to 15 minutes audiotaped information, about preterm infant and they could use this information in written form too. Then mothers answered to 10 post test questions. Finally, mothers were asked to complete each phase's workbooks until the next session. Anxiety and stress were assessed three times and participation assessment was done just one time.

General information

Acronym
C.O.P.E
IRCT registration information
IRCT registration number: IRCT138904214358N1
Registration date: 2009-09-19, 1388/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-09-19, 1388/06/28
Registrant information
Name
Soheila Jafari Mianaei
Name of organization / entity
Shaheed Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2516
Email address
soh_jafari@yahoo.com
Recruitment status
Recruitment complete
Funding source
vice-chancellor for research shaheed beheshti medical university
Expected recruitment start date
2009-09-19, 1388/06/28
Expected recruitment end date
2010-02-19, 1388/11/30
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 psychological outcomes and participation of mothers who have preterm infants hospitalized in NICUs.
Public title
Effectiveness the "Creating Opportunities for Parent Empowerment" program on psychological outcomes and participation of mothers who have preterm infants hospitalized in NICUs.
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 had not had any medical problems related to delivery or sickness, who had not had psychiatric disease and whose infants met the following criteria were eligible for participation: (a) gestational age of 26 to 34 weeks inclusive, (b) birth weight of less than 2500 grams, (c) anticipated survival, (d) singleton birth, (e) no severe handicapping conditions, and (f) born at the study sites. Exclusion criteria: mothers who left the program and didn't come back to hospital for more than 4 days, mothers whose neonate died and mothers whose infants discharged from hospital before the program ends.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
First phase was hold 2-4 days and second phase 4-8 days after NICU admission. Evaluations performed before each phase and 2-4 days after second phase. Control group just used routine NICU's cares.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shaheed Beheshti Medical University
Street address
Tehran, velenjak
City
Tehran
Postal code
Approval date
2010-04-18, 1389/01/29
Ethics committee reference number
88-01-86-6791-1

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
Z63.7
ICD-10 code description
Other stressful life events affecting family and household

2

Description of health condition studied
Stress
ICD-10 code
Z75.8
ICD-10 code description
Other problems related to medical facilities and other health care

3

Description of health condition studied
Participation
ICD-10 code
Z76.3
ICD-10 code description
Healthy person accompanying sick person

Primary outcomes

1

Description
anxiety
Timepoint
2-4 days after infant hospitalization, 2-4 days after first phase, 2-4 days after second phase
Method of measurement
State-Trait Anxiety Inventory

2

Description
stress
Timepoint
2-4 days after infant hospitalization, 2-4 days after first phase, 2-4 days after second phase
Method of measurement
Parental Stressor Scale: Neonatal Intensive Care Unit

3

Description
participation
Timepoint
2-4 days after second phase
Method of measurement
The Index of Participation/Hospitalized Infant

Secondary outcomes

empty

Intervention groups

1

Description
Intervention had two phases; First phase was hold 2-4 days and second phase 4-8 days after NICU admission. In each session mothers listened to 15 minutes audiotaped information about preterm infant and they could use this information in written form. For the purpose of the evaluation of the education, mothers answered 10 post test questions. Finally mothers were asked to complete each phases work books.
Category
Behavior

2

Description
Control group just used routine NICU's cares
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Beheshti hospital
Full name of responsible person
Ms Rezvan
Street address
Shaheed Motahari street
City
Isfahan

2

Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Ms Sheikh zadeh
Street address
Hakim nezami
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research Shaheed Beheshti Medical University
Full name of responsible person
Vice-Chancellor for research
Street address
Velenjak
City
Tehran
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 Shaheed Beheshti Medical University
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
Shaheed Beheshti Medical University
Full name of responsible person
Soheila Jafari Mianaei
Position
Master of Science in nursing
Other areas of specialty/work
Street address
No.51, Shaheed Ghaderi ally, Kangaz st, Jey st
City
Isfahan
Postal code
17889-81591
Phone
+98 31 1521 2527
Fax
+98 31 1320 7702
Email
soh_jafari@yahoo.comjafari.soheila@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
member of faculty, Shaheed Beheshti Medical University
Full name of responsible person
Fatemeh Alaee Karahroudy
Position
Master of Science in nursing
Other areas of specialty/work
Street address
Nursing & Midwifery College, Valiasr st.
City
Tehran
Postal code
Phone
+98 21 8846 5140
Fax
Email
falaee@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shaheed Beheshti Medical University
Full name of responsible person
Soheila Jafari Mianaei
Position
Master of Science in nursing
Other areas of specialty/work
Street address
No.51, Shaheed Ghaderi ally, Kangaz st, Jey st
City
Isfahan
Postal code
Phone
Fax
Email
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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