Objectives: the aim of this study is to determine the effect of progressive muscle relaxation on sleep quality in patients with chronic heart failure. Design: this non-blinding randomized controlled trial is done in CCU wards of Fatemeh Zahra Hospital in Sari. Study population: patients with chronic heart failure. Inclusion criteria: age older than 18 yearsold; NYHA class 2 and 3; at least 3 months past history; Pittsburgh score of 5 or higher; no consumption of sedatives, antidepressants and antihistamines. Exclusion criteria: no cooperation; consumption of sedatives; not doing relaxation more than 10% (6 times ) during the study; be candidate for cardiac invasive procedures. Sample size: 90 patients are divided into two groups: intervention and control. Intervention: progressive muscle relaxation is taught during three sessions in each patient. The first session is hold after stabilization of clinical signs, for 30 minutes. The second session is done at the evening of the same day, for 15 minutes. The third session is hold the next morning, for 15 minutes. After obtaining properly feedback, relaxation educational booklet associated with a CD and an event recording check list are delivered to patients and asked them to do this technique twice daily (once in the morning and once at night before sleeping), for one month . In order to evaluation,telephone follow up of patients is done by researcher weekly. The patients of control group will receive the usual care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070428101N2
Registration date:2016-07-24, 1395/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-24, 1395/05/03
Registrant information
Name
Zohreh Taraghi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
ztaraghi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-07-05, 1395/04/15
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation on sleep quality in patients with chronic heart failure
Public title
Sleep quality in heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age older than18 years old; NYHA class 2 and 3; at least 3 months past history; established clinical signs; Pittsburgh score of 5 or higher; no consumption of sedatives, antidepressants and antihistamines. Exclusion criteria: no cooperation, consumption of sedatives, not doing relaxation more than 10% ( 6 times ) during the study and be candidate for cardiac invasive procedures.
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
ٍEthics Committee of Mazandaran University of Medical Sciences
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4816715793
Approval date
2016-06-28, 1395/04/08
Ethics committee reference number
IR.MAZUMS.REC.95.2193
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
G47
ICD-10 code description
Sleep Disorders
Primary outcomes
1
Description
Sleep quality
Timepoint
Before Intervention, one month after Intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, progressive muscle relaxation is taught during three sessions in each patient.The first session is hold after stabilization of clinical signs, for 30 minute. The second session is done at the evening of the same day, for 15 minutes. The third session is hold the next morning, for 15 minutes. After obtaining properly feedback, relaxation educational booklets associated with a CD and an event recording check list are delivered to the patients and asked them to do this technique twice daily( once in the morning and once at night before sleeping) for one month. In order to evaluation,telephone follow up of patients is done by researcher weekly.
Category
Behavior
2
Description
The patients of control group will receive the usual care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital, Sari
Full name of responsible person
Samaneh Yousefi
Street address
Fatemeh Zahra Hospital, Military Boulevard, Municipality Square, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
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 for research, 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
Samaneh yousefi
Position
Master Student in Critical care nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4816715793
Phone
+98 11 4208 1104
Fax
+98 15 1226 8915
Email
samaneh.yousefi66@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Taraghi
Position
Assisstant Professor
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4816715793
Phone
+98 11 3379 5585
Fax
+98 15 1226 8915
Email
ztaraghi@mazums.ac.ir; ztarair@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Samaneh Yousefi
Position
Master student in Critical care nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Vesal street, Sari
City
Sari
Postal code
4816715793
Phone
+98 11 4208 1104
Fax
+98 15 1226 8915
Email
samaneh.yousefi66@gmail.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)