Objectives: The aim of this study is to determine the effect of preferred music on sleep quality, hospital anxiety and depression level among patients after coronary artery bypass surgery. Design: In this clinical trial study, 70 patients who undergone coronary artery bypass surgery and are hospitalized in a hospital affiliated to Alborz University of Medical Science, If the patients have all inclusion criteria includes: Being conscious and oriented to time, place and person; Undergoing non-emergency open heart surgery for the first time; Age between 30 to 75 years old; Stable hemodynamic condition; Having no mental disorders; Understanding Persian language; Not drug and alcohol addicted; Having no hearing impairment, after obtaining consent, will be enrolled in the study. Patient will be assigned after the purposive sampling as blocked randomization to experiment and control groups. Before commence of the intervention will be measured sleep quality by Pittsburgh questionnaire and hospital anxiety and depression by HADS questionnaire. After that patients in the experiment group will listen to their preferred music that is instrumental and relaxing and using MP3 player with headphones for 20 minutes once a day during four days at 4-6 pm in the afternoon. While patients in control group will receive only routine caring. Finally, once again sleep quality, anxiety and depression will be measured and compared in the five day. Main outcome measures (variables): sleep quality, anxiety and depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408185987N14
Registration date:2015-02-16, 1393/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-16, 1393/11/27
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-09-02, 1393/06/11
Expected recruitment end date
2014-11-30, 1393/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of preferred music on sleep quality, hospital anxiety and depression among patients after coronary artery bypass surgery
Public title
The effects of preferred music on sleep quality- hospital anxiety and depression among patients after coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study; Undergoing non-emergency open heart surgery for the first time; Age between 30 to 75 years old; Stable hemodynamic condition such as systolic blood pressure higher than 90 mmHg; lack of life threatening dysrhythmia and a heart rate between 60 and 100 bpm; Having no mental disorders; Understanding Persian language; Not drug and alcohol addicted; Willingness to hear music; Having no hearing impairment that prevents using headphones; Being conscious and oriented to time; place and person; Undertaking a routine surgical procedure in the operating room such as saphenous vein graft without unexpected events such as severe bleeding or prolong operation. Exclusion criteria: Suffering from acute complications associated with surgery such as bleeding more than 200cc/h of chest tubes, Cardiac tamponade, life threatening dysrhythmias or any emergency condition that requires immediate intervention; Willingness to quit from the study; Death during the study.
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
1Ethics committee, Tehran University of Medical Sciences
Street address
The central building of Tehran University of Medical Sciences, Qods Street, Keshavarz Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-08-31, 1393/06/09
Ethics committee reference number
130/1146
Health conditions studied
1
Description of health condition studied
Heart Surgery
ICD-10 code
I97.1
ICD-10 code description
Other functional disturbances following cardiac surgery
Primary outcomes
1
Description
Sleep quality
Timepoint
The first and five days
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Hospital Anxiety and Depression
Timepoint
The first and five days
Method of measurement
Hospital Anxiety Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
Listening to music with headphones. Intervention time during four consecutive days for 20 minutes at 4-6 pm
Category
Treatment - Other
2
Description
In the control group will not be done any intervention and take only routine caring
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital of Alborz University of Medical Sciences
Full name of responsible person
Robabeh Haghverdi
Street address
Shahid Rajaei Hospital - Hesarak - karaj - Alborz
City
karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masood Younesian
Street address
The central building of Tehran University of Medical Sciences, Qods Street, Keshavarz Street, Tehran, Iran
City
Tehran
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, Tehran 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
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Robabeh Haghverdi
Position
Student of Nursing in Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Street, Tohid square, Tehran, Iran
City
Tehran
Postal code
3158657796
Phone
+98 26 3280 1285
Fax
Email
Haghverdi110@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery,Tehran University of Medical Scienses
Full name of responsible person
Shahrzad Ghiyasvandian
Position
PHD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Street, Tohid square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6642 0739
Fax
+98 66904252
Email
Shghiyas@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Science
Full name of responsible person
Robabeh Haghverdi
Position
Master Sciences Student of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery of Tehran University of Medical Sciences, Nosrat Street, Tohid square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 26 3280 1285
Fax
Email
Haghverdi110@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)