Determining the effect of music on quality of sleep in patients with heart failure
Design
Randomized controlled clinical trial with control group design of 38 patients in each group. Blocked randomization with quadruple blocks of patients and the formation of random strings and sampling based on it.
Settings and conduct
The research community included patients with heart failure and the research environment is the cardiac ward of the selected hospital of the Social Security Organization in Tehran. Research samle: Patients with heart failure admitted to the cardiac ward of the selected hospital of Social Security Organization in Tehran that are studied according to entry criteria and are examined.
Participants/Inclusion and exclusion criteria
A confirmed diagnosis of HF(EF<40%); HF functional class II to IV according to New York Heart Association classification; Poor sleep quality according to Pitsburge sleep quality index; Age above 18 years; Stable situation of disease; No taking hypnotic drugs or medication with sleep complications when entering the study; No habit of listening to nature sound music for sleep; No existence of intra cardiac defibrillator; No sever neurologic disorder such as Parkinson's or Alzheimer's
Intervention groups
Intervention is the music box of the sounds of nature with the combination of classical nonverbal music. Patients in the intervention group, in addition to receiving regular care, listen to the music through headphones and for 30 minutes during 7 nights before bedtime. Patients in the control group receive only the usual care of the ward.
Main outcome variables
Evaluation of sleep quality in patients with heart failure; The Effect of Music on Improving Sleep Quality in Patients with Heart Failure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100725004443N25
Registration date:2019-01-09, 1397/10/19
Registration timing:retrospective
Last update:2019-01-09, 1397/10/19
Update count:0
Registration date
2019-01-09, 1397/10/19
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Music on the Quality of Sleep in Patients with Heart Failure
Public title
The Impact of Music on Sleep in Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A confirmed diagnosis of HF by cardiologist
HF functional classification I to IV according to New York Heart Association
Age above 18 years
Poor sleep quality according to pitsburge sleep quality index
Stable situation of disease
Exclusion criteria:
Cancellation of participation in research
Entry into the acute phase of disease
Reduce level of consciousness
Deafness
The habit of listening to nature sound music for sleep
Existence of intra-cardiac implantation defibrillator(ICD)
Discharge earlier than 3 days
Sever neurologic disorders such as Parkinson's or Alzeimer's
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization type is blocked randomization. Foursquare blocks of intervention group(A) and control(B) are defined on cards 1-6 (AABB,ABAB,ABBA,BBAA,BABA,BAAB), the cards are placed inside the envelope.
Then the cards are selected randomly and then random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence. During the intervention, the curtains around the patient's unit are pulled.
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 Tehran university of medical sciences
Street address
Office building of Tehran University of medical Sciences, Keshavarz St, Tehran.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4352
Health conditions studied
1
Description of health condition studied
Heart Failure
ICD-10 code
I50.2
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
Poor sleep quality score in Pittsburgh sleep quality questionnaire
Timepoint
Measurement of sleep quality before intervention and 7 days after listening to the nature sounds music
Method of measurement
Pittsburgh Sleep Quality Index Past Week Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in addition to receiving the usual care of the ward, they listen to the music box sounds of nature with the combination of classical music through headphones for 30 minutes before night sleep, during 3 days of hospitalization.
Category
Treatment - Other
2
Description
Control group: patients receive usual care of the ward.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
No.12734,near by Iran university of medical science,Hemat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614531
Phone
+98 21 82039
Fax
+98 21 8806 2005
Email
www.miladhospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraian
Street address
Research deputy of Tehran University of Medical Sciences, No. 21, Qods St., Keshavarz Blvd., Tehran Town,
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8163 3698
Fax
Email
msahrai@tuma.ac.ir
Web page address
Grant name
Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Nursing education PHD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
zakerimo@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
zakerimo@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
zakerimo@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available