The aim of this study was to evaluate the effect Qur’an Sonance on sleep quality in elderly residents of nursing homes. Study design: Clinical trial˓ Randomly allocated to intervention and control groups˓ Multicenter˓ Not blinded.
Inclusion criteria: Having their written consent for taking part in this study; at the least 60 years ; good mental health ; do not have uncontrolled chronic disease and severe auditory disorder ; staying in nursing homes ; participants were capable of answering the questions ; do not have sleep-related illnesses, such as obstructive sleep apnea and restless leg syndrome ; are not being addicted to narcotic , analgesic , antidepressant , hypnotic drugs and alcohol; willingness to hear the Qur’an Sonance.
Exclusion criterian : do not want to listen toQur’an Sonance during study ; listen to any sound other than the Qur’an Sonance before bedtime; unwillingness to cooperate during the investigation; Exclusion for reasons such as illness, death or transfer to other centers ; Unwillingness to cooperate during the investigation; using sleeping medications.
Nursing homes of Malaye are research community and sample size is 70 elderly persons.
Intervention : Chapter Al-Mu'minun with pleasant voice Parhyzgar is played with headphone through MP3 player for 15 minutes every night before sleep, lasted four weeks.
Measure the sleep quality of elderly persons in the control and intervention group using Pittsburgh questionnaire.
Main outcome measures (variables): Overall sleep quality, mental qualities of sleep, sleep latency, sleep duration, sleep efficiency, and sleep disorder and daily dysfunction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120231192N1
Registration date:2017-03-06, 1395/12/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-06, 1395/12/16
Registrant information
Name
Abbas Hossini
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 7267
Email address
abbashossiniz@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Qazvin University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Holy Qur’an Sonance on the Quality of Sleep among Elderly of the nursing Homes
Public title
The Effect of Holy Qur’an Sonance on the Quality of Sleep among Elderly of the nursing Homes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having their written consent for taking part in this study; Having at the least 60 years ;Having mental health ; absent uncontrolled chronic disease and severe auditory disorder ; Residing in nursing homes ; participants were capable of answering the questions ; Absent of sleep-related illnesses, such as obstructive sleep apnea and restless leg syndrome ; Independence to narcotic, analgesic , antidepressant , hypnotic drugs and alcohol; Willingness to hear the Qur'an
Exclusion criterian : Cutting to listen to Qur’an Sonance during study ; listen to any sound other than Qur’an Sonance before bedtime; unwillingness to cooperate during the investigation; Exclusion for reasons such as illness, death or transfer to other centers ; using sleeping medications
Age
From 60 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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Qazvin University of Medical Sciences
Street address
School of Nursing and Midwifery, University of Medical Sciences , Shahyd Bahonar Boulevard , Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2016-07-21, 1395/04/31
Ethics committee reference number
28/20/12474 The code of ethics IR.QUMS.REC.1395.114
Health conditions studied
1
Description of health condition studied
insomnias
ICD-10 code
G47.2
ICD-10 code description
Disorders of the sleep-wake schedule
Primary outcomes
1
Description
The overall quality of sleep
Timepoint
Before and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
2
Description
Subjective sleep quality
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
3
Description
Sleep duration
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
4
Description
Sleep efficiency
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
5
Description
Sleep disturbances
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
6
Description
Day time dysfunction
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
7
Description
Sleep latency
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Use of sleep medications
Timepoint
Before intervention and one week after the intervention
Method of measurement
The Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Chapter Al-Mu'minun with pleasant voice Master Parhyzgar is played for 15 minutes every night before sleep through mp3 player with headphones for four weeks.
Category
Treatment - Other
2
Description
There isnot any intervention for control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Aging Center Emam Ali
Full name of responsible person
Ali Noruzy
Street address
Aging Center Emam Ali ,Gorab Village , Malayer
City
Malayer
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Qazvin University of Medical Sciences
Full name of responsible person
Fateme Mohamadi
Street address
Vice chancellor for Research, Qazvin University of Medical Sciences ,Boulevard Bahonar , Qazvin
City
Qazvin
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, Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Abbas Hossini
Position
Master Student of Geriatric Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery ; University of Medical Sciences ; Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 7267
Fax
Email
abbashossiniz@gmail.com; abbashossiniz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Geriatric Nursing Ph.D.
Other areas of specialty/work
Street address
School of Nursing and Midwifery , University of Medical Sciences , Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 7267
Fax
Email
fmohammadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Medical Sciences
Full name of responsible person
Abbas Hossini
Position
Master Student of Geriatric Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery ; University of Medical Sciences Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 7267
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)