The Effect of Traditional Music on Sleep Quality in Elderlies
Design
This study is a randomized clinical trial (Randomized Controlled Trial).Sampling was done randomly from among elderly people with sleep disorders in Sirjan city . In this study, 70 people were selected using randomized block sampling (35 in the intervention group and 35 in the control group) from the elderly over 60 years old.
Settings and conduct
This study is a randomized clinical trial (Randomized Controlled Trial). The population is the elderly of Sirjan Hospital Clinic and subsidiary clinics who are referred to the clinic due to sleep disorders. The sampling was easy and available, but the allocation of individuals to intervention and control groups was random.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The Pittsburgh Sleep Quality Index more than 5; Exclusion criteria: mental health problems, alcohol or drug use history, previous use of drugs for sleep disorders, severe physical disease, hearing impairment, night shift workers.
Intervention groups
The study has two groups . music was played for the cases For 45 minutes before bedtime . To ensure proper intervention, all details were communicated to one of the family members.Listen to the music of the selected band every night. Every week, the researcher made phone calls twice to encourage the group to continue the music and also to accurately record the requested information.and the control group were asked to not listen to music at night
Main outcome variables
quality of sleep
General information
Reason for update
Acronym
Pittsburgh Sleep Quality Index; PSQI
IRCT registration information
IRCT registration number:IRCT20150519022320N10
Registration date:2018-03-09, 1396/12/18
Registration timing:retrospective
Last update:2018-03-09, 1396/12/18
Update count:0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-02-17, 1395/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Traditional Music on Sleep Quality in Elderlies
Public title
The Effect of Traditional Music on Sleep Quality in Elderlies
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
lack of mental health problems
lack of alcohol or drug history
lack of previous use of drugs for sleep disorders
lack of severe physical disease
lack of hearing impairment
lack of the night shift
Get a score of more than 5 from the Pittsburgh Inventory
Exclusion criteria:
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial state of sleep disorder was measured. By knowing the sample size, each numerical code is allocated to each hypothetical person and then randomly, half of these individuals are assigned to the intervention group and the other half to the control group and divided into two groups of intervention and control
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 Rafsanjan University of Medical Sciences
Street address
Emam Ali Bilvar
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.RUMS.REC.1394.125
Health conditions studied
1
Description of health condition studied
Sleep quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep Quality
Timepoint
Measurement of sleep quality was performed before and after intervention, 7, 14 and 21 days after the onset of intervention after waking up.
Method of measurement
Pittsburgh Sleep Quality Index; PSQI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After selecting the music of the participants in group were asked to sleep in a darkened room, quiet and has a ventilation system, appropriate temperature and enough light . The researchers suggest music pieces, music by a group of professionals was assembled from parts Iranian music which instrumental flute and dulcimer instrument was used in this piece and of the same quality and there was no sudden changes in sound and rhythm. For 45 minutes before bedtime music was played for the cases.
Category
Rehabilitation
2
Description
Control group: the control group were asked to not listen to music at night
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized clinic of Gharazi Hospital
Full name of responsible person
Zahra Rahimpoor
Street address
Shafa Ave
City
Sirjan
Province
Kerman
Postal code
7817835816
Phone
+98 34 4142 2410
Email
t.mirzaei@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamce Zadeh
Street address
nurse Ave
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3834 2834
Email
t.mirzaei@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayyebeh mirzaei
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Street Nursing ،faculty of Nursing
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34383428
Email
t.mirzaei@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Tayyebeh mirzaei
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
street Nursing ،faculyy of nursing
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34383428
Email
t.mirzaei@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
mohadeseh raeesi
Position
Research expert
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Street Nursing ، Faculty of nursing
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34383428
Email
mraesi@ymail.com
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