Protocol summary

Summary
Effects of family-patients hope promoting interventions based on religious recommendations on quality of lif of CHF patients Purpose: The purpose of this research will be to define the efficacy of hope promoting interventions based on religious recommendations on quality of life among Congestive Heart Failure patients who were referred to hospitals affiliated to Isfahan University of Medical Sciences in 2013. Design:This study is a randomized clinical trial with control group and will be implemented as a pre-test, post-test and follow up(1 month). Major Inclusion and Exclusion criteria and Setting and conduct: 46 Muslim persons that their ages are 18 years and older, With a diagnosis of heart failure in classes 1 and 2, Who have no serious medical illness, and willing to participate in the study will be selected. If they do not consent to continue participation in the study and use other methods of complementary medicine will be excluded, then they will be located randomly in two intervention and Control groups. Intervention:Intervention group will be accompanied in 6 seasons of 1 hour of the hope promoting interventions that will be held in 6 centers of hospitals affiliated to Isfahan University of Medical Sciences, and the Ferrans and Powers Quality of Life Index (Main outcome variable measure) will be completed in 3 steps, pretest, post test and follow up ( 1 month) in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014100619413N1
Registration date: 2014-12-09, 1393/09/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-09, 1393/09/18
Registrant information
Name
Niloufar Binaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 983137922935
Email address
m_zamani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Isfahan University of Medical Sciences, Isfahan, Iran.
Expected recruitment start date
2013-10-02, 1392/07/10
Expected recruitment end date
2014-01-28, 1392/11/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of family-patients hope promoting interventions based on religious recommendations on quality of lif of CHF patients
Public title
Effects of hope promoting interventions on quality of lif of CHF patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for patients : Age 18 years and older; Catching heart failure class 1 and 2 by the specialist; Catching Heart failure for at least one year; Full Consciousness and knowledge of the time, place and person, and having no dementia; Interested in participating in the study (Dewolfe etal.2011, p.2); Being Muslim; Not having speech problems, mental (confirmed by a specialist) and hearing (Aboutalebi Daryasary et al 1390, p .204); Not having other serious medical illness that impact on quality of life and mental health (confirmed by a doctor) (sotudeh asl et al 1390, p 29). Inclusion criteria for family members: Age 18 and older; Interested in participating in the study; Being Muslim; The ability to read and write; A family member, spouse, child, parent, brother or sister who have the greatest participation in the care of his patients; Exclusion criteria: Cancel the cooperation by patient or his family during the study; Use other methods of complementary medicine by the patient or family members during the study; Death of patient or caregiver during the intervention that another not be able to continue to study; Absence of a patient or family member in more than one session of 6 sessions.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
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
Isfahan University of Medical Sciences
Street address
Isfahan- St. hezar gerib- Isfahan University of Medical Sciences
City
Isfahan
Postal code
8174673461
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
392463

Health conditions studied

1

Description of health condition studied
Congestive heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified

Primary outcomes

1

Description
Quality of Life
Timepoint
Before intervention- Immediately after the intervention- One month after the intervention
Method of measurement
Ferrans and Powers Quality of Life Index

Secondary outcomes

1

Description
does not have
Timepoint
does not have
Method of measurement
does not have

Intervention groups

1

Description
In study group and their family, 60 min sessions of hope promoting interventions based on religious recommendations will held twice a week for three weeks. The interventions have two-step of Creating Hope and Increasing Hope (Parcham & Mohagheghian2010,p.99). At the end of each session, the booklet contains the content of the session with the task of future session will give to Patients. The content of the intervention sessions include the following: The first session Purpose: Stated objectives and rules, The relationship between disease and despair, The importance and value of patient care according to the Quran and other religious instructions, Request consideration of several important purpose in life by Patients, Compare signs of frustration in Patients with what is stated in the Quran and other religious instructions, Express the importance and value of having hope and frustration Criticism. Task: Note how the Qur'an and other religious teachings affect their spirit and vision of despair. The second session Purpose: Reminder of God's blessings in personal life and attention to the Qur'an Stories of Hope and life of Imams and divine parents to find hope. Task: Prepare a list of miracles that had occurred in their lives. The third session Purpose: Benchmarking of divine parents and belief in the resurrection and hope to benefit from the mundane intercession of saints in order to consolidate hope. Task: Note their relationship with a divine parent or try to communicate with one of the parents, for example, the Imam Hussein and Imam Mahdi, Hazrat Abolfazl and etc. The fourth session Purpose: Explain the effect of individual strategies such as prayer, remembrance of God, intimacy with the Quran to strengthening of hope. Task: Use at least one of the approaches and describes its impact on their hope. The fifth Session Purpose: Explain the effect of social strategies such as charity, forgiveness and etc to strengthening of hope. Task: Use at least one of the approaches and describes its impact on their hope and hope of others. The sixth Session Purpose: Identification naughty and sensuality as human enemies and Identification obstacles to reach goals in order to maintain the hope, review of past sessions and acknowledgments.
Category
Other

2

Description
Two training sessions about the disease will be held to control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Mrs. Poor baqher
Street address
Isfahan, st. Ibne- sina
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Isfahan University of Medical Sciences, Isfahan, Iran.
Full name of responsible person
Ashraf Kazemi
Street address
Vice Chancellor for Research of Isfahan University of Medical Sciences
City
Isfahan
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 of Isfahan University of Medical Sciences, Isfahan, Iran.
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
Isfahan University of Medical Sciences
Full name of responsible person
Niloufar Binaei
Position
Student of Master of Science in Nursing
Other areas of specialty/work
Street address
Hezar Gerib AVE, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2935
Fax
Email
m_zamani@nm.mui.ac.irnb.nurs@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery,Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Mahin Moeini
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Hezar Gerib Ave, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2935
Fax
Email
nb.nurs@yahoo.com moeini@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Niloufar Binaei
Position
Student of Master of Science in Nursing
Other areas of specialty/work
Street address
Hezar Gerib Ave, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 2935
Fax
Email
m_zamani@nm.mui.ac.irnb.nurs@yahoo.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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