Protocol summary

Summary
Reduce the quality of sleep is a common problem in cardiac patients. This study aimed to investigate the effect of spiritual care based on GHALBE SALIM model - it is drived from spirituality religion and Islam faith - on the quality of sleep in patients with coronary artery disease admitted to the coronary care unit was performed. In a two-group randomized controlled clinical trial, 60 patients with coronary artery disease randomly distributed in two intervention and control groups of patients studied. With the Pittsburgh Sleep Quality questionnaire, patients' sleep quality was measured on the first day after admission. In intervention group, spiritual care program was the first day of admission until discharge. After two months, sleep quality were assessed by phone. the main Inclusion criteria was Pittsburgh Sleep Quality Scale 6 or more points and the main exclusion criteria the use of non-conventional doses of hypnotic drugs

General information

Acronym
Coronary Artery Disease-CAD
IRCT registration information
IRCT registration number: IRCT2013061113636N1
Registration date: 2013-12-10, 1392/09/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-10, 1392/09/19
Registrant information
Name
Minoo Asadzandi
Name of organization / entity
Baqiyatallah Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 8520
Email address
zandi498@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Medicine and Religion Center of Baghyatallh University- Baqyatallah Faculty of Nursing
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual care based on GHALBE SALIM model on quality of sleep in patients with coronary artery disease
Public title
The effect of spiritual care on quality of sleep
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Pittsburgh Sleep Quality Scale 6 or more points; Patient's willingness to cooperate in research; more than 18 years of age; being aware of time and place; no alcohol; no drugs and not receiving drug addiction; no medical history of mental illness and Alzheimer's patients and non-psychiatric drugs; not deaf patient (effective communication); the subject of any similar studies have not participated and untrained. Exclusion Criteria: discharge patient satisfaction with the personal intervention; patient reluctance to continue working in every phase of the research; the use of non-conventional doses of hypnotic drugs.
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
baqyatallah university
Street address
shahid hemmat highway-sheikh bahaee street-nosrati alley
City
tehran
Postal code
Approval date
2013-10-27, 1392/08/05
Ethics committee reference number
33

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Sleep quality
Timepoint
Before intervention and two months after intervention
Method of measurement
Pittsburgh Sleep Quality Scale

Secondary outcomes

1

Description
Daily spiritual experience
Timepoint
Before intervention and two months after intervention
Method of measurement
Daily spiritual experiences scale

Intervention groups

1

Description
In the intervention group, spiritual care based on GHALBE SALIM model, every day was the first day of admission until discharge and follow-up phone calls were made ​​repeatedly in two months
Category
Other

2

Description
in control group did not any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqyatallah hospital
Full name of responsible person
Mrs Taghinia, Mr Fathi
Street address
Azam alley- Sheikh Bahaee street-Shahid Hemmat highway
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Medicine and Religion center of Baqyatallah University
Full name of responsible person
Dr. Mehdi Mesri & Dr. Abbas Ebadi
Street address
(1).Nosrati alley- Sheykh Bahaee street-Shahid Hemmat highway-(2).baqyatallah university- Velayat Educational Complex- Araj Three ways- Nobonyad Sq
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medicine and Religion center of Baqyatallah 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
Faculty of Nursing, Baqyatallah University
Full name of responsible person
Minoo Asadzandi
Position
PhD- Faculty member
Other areas of specialty/work
Street address
baqyatallah nursing faculty-velayat Educational Complex-araj Three ways-nobonyad SQ
City
Tehran
Postal code
Phone
+98 21 2612 7253
Fax
Email
zandi498@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing, Baqyatallah University
Full name of responsible person
Abbas Ebadi
Position
PhD
Other areas of specialty/work
Street address
baqyatallah nursing faculty-Velayat Educational Complex-Araj three ways-Nobonyad SQ
City
Tehran
Postal code
Phone
+98 21 2612 7253
Fax
Email
ebadi1347@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing, Baqyatallah University
Full name of responsible person
Zahra Saeedi Taheri
Position
Critical Care Nursing MSc Student
Other areas of specialty/work
Street address
baqyatallah nursing faculty-Velayat Educational Complex-Araj three ways-Nobonyad SQ
City
Tehran
Postal code
Phone
+98 21 2612 7253
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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