Objectives: The present study will intend to determine the effect of music therapy on the amount of comfort and some hemodynamic parameters of patients undergoing hemodialysis. Design: Clinical trial. Setting and conduct: 74 people will select from the hemodialysis patients in Hajar and Besat Hospitals, who will select by accessible method and based on the days (even or odd days). 37 people will allocate to the test group and 37 to the control group. Major Inclusion criteria: The patient has been undergoing hemodialysis for more than six months; Do not have a known history of psychiatric diseases; Do not suffer from hearing impairments which prevents using headphones. Major Exclusion criteria: Unstable hemodynamic status; Acute pain in other parts of the body; Developing cardiac and pulmonary disorders. Interventions: A pre-test will conduct before hemodialysis using a comfort questionnaire in both the test group and control group and the vital signs will record. Music will play only for the test group during hemodialysis in three sessions, and no special action will take on the control group. After each hemodialysis session the vital signs will record, and the post-test will conduct. Main outcome: Comfort; Blood pressure; Heart rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092323446N8
Registration date:2016-10-23, 1395/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Fatemeh Teymouri
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5588 0283
Email address
z.farsi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Aja University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy on comfort rate and some vital signs of patients undergoing hemodialysis
Public title
The effect of music on comfort and vital signs of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The patient is willing to enter the study; Does not use narcotics (as it interferes with and adversely affects the result of the study in respect of the pain); More than six months has elapsed since the hemodialysis was started, and it is stable; Undergoes hemodialysis only three times a week; Does not attend as a guest from other centers; Is able to understand Farsi; Does not have a known history of psychiatric diseases; Likes music; Does not use another music during the intervention; Is between 30 to 85 years of age; Does not suffer from hearing impairments which prevents using headphones. Exclusion criteria: Unstable hemodynamic status; Acute pain in other parts of the body; Developing cardiac and pulmonary disorders; The patient’s unwillingness to hear music.
Age
From 30 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Not 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 Aja University of Medical Sciences
Street address
AJA University of Medical Sciences, Etemadzadeh St, Fatemi St, Tehran
City
Tehran
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.AJAUMS.REC.1394.44
Health conditions studied
1
Description of health condition studied
Chronic Renal Failure
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease on dialysis
Primary outcomes
1
Description
Comfort
Timepoint
Before intervention, After the first session, After the second session, After the third session.
Method of measurement
General Comfort Questionnaire Colcaba
2
Description
Blood presure
Timepoint
Before intervention, After the first session, After the second session, After the third session.
Method of measurement
Use of stethoscope and manometer
3
Description
Heart rate
Timepoint
Before intervention, After the first session, After the second session, After the third session.
Method of measurement
Use of chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Test group: The blood pressure and heart rate will record before the hemodialysis; followed by 30 minutes music therapy during the hemodialysis in three sessions; the blood pressure and heart rate will record again after the hemodialysis session.
Category
Other
2
Description
Control group: The blood pressure and heart rate will record before the hemodialysis; no intervention will make during the hemodialysis in three sessions; the blood pressure and heart rate will record again after the hemodialysis session.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Mojtaba Zarurati
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Besat Nahaja General Hospital
Full name of responsible person
Mojtaba Zarurati
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of AJA University of Medical Sciences
Full name of responsible person
Dr. Kamran Azma
Street address
AJA University of Medical Sciences, Etemadzadeh St., Fatemi St, Tehran
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 of AJA 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
AJA University of Medical Sciences
Full name of responsible person
Mojtaba Zarurati
Position
Master of science nursing student
Other areas of specialty/work
Street address
Faculty of Nursing, Kaj St, Shariati St, Tehran
City
Tehran
Postal code
Phone
+98 21 3379 5051
Fax
Email
m.zarurati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Zahra Farsi
Position
Ph.D
Other areas of specialty/work
Street address
Faculty of Nursing, Kaj St, Shariati St, Tehran
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
zahrafarsi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Mojtaba Zarurati
Position
Master of science nursing student
Other areas of specialty/work
Street address
Faculty of Nursing, Kaj St, Shariati St, Tehran
City
Tehran
Postal code
Phone
+98 21 7750 0929
Fax
Email
m.zarurati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)