Protocol summary

Summary
This randomized controlled clinical trial to evaluate the effect of Benson Relaxation Technique on quality of sleep in 60 patients with Chronic Heart Disease in Vasei hospitals in Sabzevar. Inclusion criteria: Confirmed diagnosis of Heart Failure or Myocardial Infarction; Age 30 to 60 years; Not having psychiatric disorder; Not having chronic disease; Not using sedatives drug. Exclusion criteria: Reluctance to continue participating in the exercises; Presence of crisis or disaster during the intervention period; Death; Use of sedatives drug. After obtaining permission from the Research Ethics Committee of Sabzevar University of Medical Sciences and informed consent of patients entering the study, patients were randomly allocated to two groups, 30 patients in experimental group and 30 in control group. The experimental group receive supportive intervention and get education of Benson Relaxation Technique and every patient get one CD and pamphlet for use in home. Patients in experimental group did Benson Relaxation Technique for 20 minute, twice a day during one month. The control group did not receive any intervention. The Pittsburgh Sleep Quality Index completed before and one month after intervention for all patients in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014052617865N1
Registration date: 2014-06-18, 1393/03/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-06-18, 1393/03/28
Registrant information
Name
Seyed Morteza Hashemi Nik
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
morteza.hasheminik@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2014-01-05, 1392/10/15
Expected recruitment end date
2014-03-18, 1392/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Benson Relaxation Technique on quality of sleep in patients with Chronic Heart Disease.
Public title
Effect of Benson Relaxation on quality of sleep in cardiac patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Confirmed diagnosis of Heart Failure or Myocardial Infarction; Age 30 to 60 years; Not any psychiatric disorder; Not any chronic disease; Not using sedatives drug. Exclusion criteria: Reluctance to continue participating in the exercises; Presence of crisis or disaster during the intervention period; Death, Use of sedatives drug.
Age
From 30 years old to 60 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
Sabzevar University of Medical Scinces
Street address
School of Nursing and Midwifery; Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Approval date
2013-12-26, 1392/10/05
Ethics committee reference number
medsab.rec.92.10

Health conditions studied

1

Description of health condition studied
Chronic Heart Disease
ICD-10 code
I25.9 / I5
ICD-10 code description
Chronic Ischaemic Heart Disease, unspecified / Heart Failure, unspecified

Primary outcomes

1

Description
Quality of sleep in patients with Chronic Heart Disease
Timepoint
Before the intervention and one month after intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: After obtaining permission from the Research Ethics Committee of Sabzevar University of Medical Sciences and informed consent of patients entering the study, patients were randomly allocated to two groups, 30 patients in experimental group and 30 patients in control group. The experimental group receive supportive intervention and get education of Benson Relaxation and every patient get one CD and pamphlet for use in home. Patients in experimental group did Benson Relaxation for 20 minute, twice a day during one month. The Pittsburgh Sleep Quality Index completed before and one month after intervention for patients in experimental group.
Category
Behavior

2

Description
Control group: After obtaining permission from the Research Ethics Committee of Sabzevar University of Medical Sciences and informed consent of patients entering the study, patients were randomly allocated to two groups, 30 patients in experimental group and 30 patients in control group. The control group did not receive any intervention. The Pittsburgh Sleep Quality Index completed before and one month after Research for patients in control group.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Center of education, research and treatment of Vasei Sabzevar
Full name of responsible person
Street address
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
School of Nursing and Midwifery; Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Morteza Hashemi Nik
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
ایران
Phone
+98 57 1444 6070
Fax
Email
morteza.hasheminik@yahoo.com; criticalcare2013@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Roya Akbarzadeh
Position
MSc / Member of Faculty
Other areas of specialty/work
Street address
School of Paramedics; Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
roakbarzadeh53@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Morteza Hashemi Nik
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
00
Fax
Email
morteza.hasheminik@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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