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The effect of family support programs on depression, anxiety, stress and satisfaction of family caregiver`s in patients' open heart surgery.

Protocol summary

Summary
Objective: This study aimed to determine the effect of family support program on the anxiety, depression, stress, and satisfaction of the family caregivers of patients with open heart surgery. Samples: Ninety family caregivers of the patients undergoing open heart surgery in FATEMEH- ZAHRA Hospital, Sari, Iran recruited in the study. Inclusion criteria: Family member should have a key role in the patient’s care, have the ability to read and understand Persian, be at least18 years old, not have a history of taking care of a cardiac surgical patient, not be a member of the healthcare team, and finally the patient shouldn’t be the candidate of emergency surgery. Exclusion criteria: Occurrence of any postoperative complications such as bleeding, reoperation, etc.; the patient is extubated in the first 24 hours after surgery, the patient or her/his family members cannot participate in all instructional sessions. Intervention: In this experimental clinical trial, the participants will be divided into experimental and control groups. In the experimental group, family caregivers receive information support ,instructional sessions and booklets, phone calls along with emotional support. On the other hand the control group receives the routine hospital support. Anxiety, depression, and stress levels were measured by DASS21 questionnaire and Satisfaction measured with satisfaction of the family members of patients in Intensive Care Units questionnaire

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051624342N2
Registration date: 2016-07-01, 1395/04/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Vida Shafipour
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
v.shafipour@mazuma.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research and Technology , Mazandaran University of Medical Sciences
Expected recruitment start date
2016-05-17, 1395/02/28
Expected recruitment end date
2016-09-18, 1395/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family support programs on depression, anxiety, stress and satisfaction of family caregiver`s in patients' open heart surgery.
Public title
The effect of family support programs on depression, anxiety, stress and satisfaction of family caregiver`s in patients' open heart surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Family member should have a key role in the patient’s care, have the ability to read and understand Persian, be at least18 years old, not have a history of taking care of a cardiac surgical patient, not be a member of the healthcare team, and finally the patient shouldn’t be the candidate of emergency surgery. Exclusion criteria: Occurrence of any postoperative complications such as bleeding, reoperation, etc.; the patient is extubated in the first 24 hours after surgery, the patient or her/his family members cannot participate in all instructional sessions.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
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
Mazandaran University of Medical Sciences Ethics Committee
Street address
Moalem Square,
City
Sari,
Postal code
4816715793
Approval date
2016-05-14, 1395/02/25
Ethics committee reference number
IR.Mazums.REC.95-2118

Health conditions studied

1

Description of health condition studied
Family caregiver`s, patients candidate for open heart surgery
ICD-10 code
Z95
ICD-10 code description
Presence of cardiac and vascular implants and grafts

Primary outcomes

1

Description
Depression, Anxiety and Stress
Timepoint
One day before surgery ,24 hours before dischage,14 days after discharge
Method of measurement
Depression Anxiety Stress Scales (DASS)

Secondary outcomes

1

Description
Satisfaction with family caregiver`s
Timepoint
24 hours before discharge from hospital
Method of measurement
Satisfaction Questionnaire family members of adult patients hospitalized in intensive care

Intervention groups

1

Description
Intervention Group: The intervention mainly will be done based on two aspects: informational support including instructional sessions and booklets, and phone calls with caregivers. Another aspect called emotional support includes giving enough time to the family member to talk about her/his concerns, fears, and their feelings, making them sure about the provision of adequate care at the hospital, and encouraging the family caregivers to be hopeful and trust in God
Category
Other

2

Description
The control group: Receiving usual hospital routine
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital Of Heart
Full name of responsible person
Ahmad Ali Enayati
Street address
Artesh Street,
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Research and Technology, Mazandaran 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
Mazandaran University of Medical Sciences,
Full name of responsible person
Fariba Shoushi
Position
Master Critical Care Nursing Student,
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences
City
Sari,
Postal code
Phone
+98 33795555
Fax
Email
r.shoushi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vida SHafipour
Position
Phd.Educational Nursing
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street
City
Sari,
Postal code
Phone
+98 11 3336 7342
Fax
Email
v.shafipour@mazuma.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fariba SHoushi
Position
Master Critical Care Nursing Student
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street
City
Sari,
Postal code
Phone
+98 33795555
Fax
Email
r.shoushi@gmail.com
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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