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Effect of Quran on physiological parameters of the elderly admitted in the medical departments

Protocol summary

Study aim
Determining the Effect of Hearing Quranic Voices on Physiological Indices of admitted elderly
Design
Clinical trial with control group, one blind, non-randomized
Settings and conduct
The researcher, attending internal sections of the Hashemi Hospital, will provide a daily list of elderly people who have the characteristics of the research unit and will randomly place them on paired dates, in the test group and on the days of the individual in the control group. Data analyzer is blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria include elderly women and men over 60 years of age, lack of hearing impairment, non-use of blood pressure medication, non-eligibility for chronic diseases that affects vital signs. Exit criteria include not having acute mental illness and lack of Cognitive impairment is the reluctance of the elderly to continue to participate in the study and to have an acute illness.
Intervention groups
Immediately prior to the intervention, the vital signs of the elderly (pulse, respiration, blood pressure and temperature) are measured to provide basic information; in the next stage, for the research units in the intervention group, the voice of the Quran, with the voice of the master, is derived from the Surah Yusuf verses 1 to 50 is played through headphones for 15 minutes, when the intensity of the sound is adjusted according to the desire of the elderly. This intervention takes place within 15 minutes and only once. Immediately after completing the 15-minute listening session of the Quran, the vital signs are again measured and recorded by the researcher or researcher's assistance. In the control group, the vital signs of the elderly are monitored and recorded immediately before and after 15 minutes of usual care
Main outcome variables
Systolic and diastolic blood pressure, pulse, respiration, body temperature

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180924041121N1
Registration date: 2018-10-30, 1397/08/08
Registration timing: registered_while_recruiting

Last update: 2018-10-30, 1397/08/08
Update count: 0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Fateme Mohseninejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3623 2617
Email address
f.mohseninejad@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-21, 1397/07/29
Expected recruitment end date
2018-11-20, 1397/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Quran on physiological parameters of the elderly admitted in the medical departments
Public title
Effect of Quran on physiological parameters of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly women and men over 60 years of age Not having a hearing problem (history of using cognoscope, ear surgery, curettage, tinnitus, working in a noisy environment, not receiving an autosomalous drug for more than a week, etc.) Non-development of diseases that chronicly disturb vital signs Not having acute mental illness Not having cognitive impairment Not taking blood pressure medication
Exclusion criteria:
Elderly reluctance to continue studying Acute illness
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer is kept blind.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee ofNorth Khorasan University of Medical Sciences
Street address
Nk. 193, West Varzesh
City
Shirvan
Province
North Khorasan
Postal code
9461638573
Approval date
2018-09-09, 1397/06/18
Ethics committee reference number
IR.NKUMS.REC.1397.038

Health conditions studied

1

Description of health condition studied
physiological parameters of the elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The heart rate pulse or heart rate controlled by the researcher in the radial wrist in one minute immediately before the start and immediately after the interruption of the hearing is audible.
Timepoint
immediately before intervention and immediately after intervention
Method of measurement
Hours of sentiment

2

Description
The number of breathing or counting the number of movements of the chest wall (one full tail and exhalation) of the elder in one full minute
Timepoint
immediately before intervention and immediately after intervention
Method of measurement
Counting the chest movements in a perfect minute by the researcher

3

Description
Elderly blood pressure
Timepoint
immediately before intervention and immediately after intervention
Method of measurement
Pressure gauge

4

Description
The temperature of the elderly body
Timepoint
immediately before intervention and immediately after intervention
Method of measurement
Mercury Therommeter

Secondary outcomes

empty

Intervention groups

1

Description
After receiving written informed consent from them, the elderly will first be studied in the course of the study and how it will be done, and the independent variable effects (Quranic verses) on the dependent variable (physiological indicators) will be examined. Trying to collaborate with departmental officials, research units in less crowded rooms. Intervention will take place every day at a specified time. Since the lowest congestion time (visitation, visitation, nursing, medication, etc.) is at the beginning of the night shift, the intervention was carried out at 8-9 nights. For the units of research in the intervention group, the voice The Qur'an, with the voice of the Master, is derived from Sura Yusuf verses 1 through 50 through headphones for 15 minutes, with the intensity adjusted according to the desire of the elderly. This intervention is performed in 15 minutes and only once. The vital signs of the elderly (pulse, respiration, blood pressure and temperature) are measured immediately before intervention and immediately after intervention.y adjusted according to the desire of the elderly. This intervention takes place within 15 minutes and only one partner.Intervention group:
Category
Other

2

Description
In the control group, the vital signs of the elderly are monitored and recorded immediately before and after 15 minutes of usual care. (It is necessary to explain that in order to remove the effect of the researcher in the Qur'anic voice group, the control group is also accompanied by the researcher during the study and if necessary, they will receive the standard care received in the control group)Control group:
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
North Khorasan University of Medical Sciences
Full name of responsible person
Fariman Ebrahimzadeh
Street address
Central Building of North Khorasan University of Medical Sciences, Government Boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7095
Email
info@nkums.ac.ir
Web page address
http://nkums.ac.ir/Category/22227

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Seyed Kaveh Hojjat
Street address
Bojnourd, Government Boulevard, Central Building of North Khorasan University of Medical Sciences
City
Bojnoord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7095
Email
K.hojjat@NKUMS.AC.IR
Web page address
http://research.nkums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Fariman Ebrahimzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Central Building of North Khorasan University of Medical Sciences, Government Boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151
Email
f.ebrahimzadeh@nkums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Fariman Ebrahimzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Central Building of North Khorasan University of Medical Sciences, Government Boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151
Email
f.ebrahimzadeh@nkums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Fariman Ebrahimzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
آدرس خیابان Central Building of North Khorasan University of Medical Sciences, Government Boulevard, Bojnourd
City
Bojnord
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3151
Email
f.ebrahimzadeh@nkums.ac.ir
Web page address
http://nurse.nkums.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
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