Determine the effect of cherry juice on elderly sleep quality
Design
This randomized clinical trial was conducted on 102 elderlies residing in Mashhad's elderly homes the first with using Pittsburgh sleep quality questionnaire, their sleep status were checked and recorded then, in the sour cherry juice group, for 15 days at 9-10 PM, as much as 200 cc of natural sour cherry choice is given. In the placebo group, 200 cc of placebo is given to them in the same way. No action is taken for the control group. The quality of sleep will be determined and compared immediately after the intervention (on the 15th day) and two weeks after the intervention and on the 30th day before such as the pre- intervention way.
Settings and conduct
Mashhad's elderly homes (Toos and Ashianmehr), selected randomly and divided into three intervention groups (sour cherry juice), placebo and control
Participants/Inclusion and exclusion criteria
willingness to participate in the study; age over 60 years old; obtaining a score of at least 7 from the short-term cognitive questionnaire; having at least one of the seven disturbing items in sleep quality based on the Pittsburgh's questionnaire; written consent to participate in the research; having the ability to communicate with the researcher.
refusal to continue to participate in the study and collaborate with the researcher; having acute illness or hospitalization during the study which prevents keep working; not using cherry juice or placebo for any reason more than 20% of the recommended or recommended dose.
Intervention groups
in the sour cherry juice group, for 15 days at 9-10 PM, as much as 200 cc of natural sour cherry choice is given. In the placebo group, 200 cc of placebo is given to them in the same way.
Main outcome variables
duration of sleep; number of waking up during the night; useful sleep duration; sleep disturbances; sleep quality; daily function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171009036673N2
Registration date:2018-04-13, 1397/01/24
Registration timing:retrospective
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Raouf Feizian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5252 6858
Email address
feizianar941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-09, 1396/09/18
Expected recruitment end date
2018-01-15, 1396/10/25
Actual recruitment start date
2017-12-09, 1396/09/18
Actual recruitment end date
2018-01-15, 1396/10/25
Trial completion date
empty
Scientific title
The Effect of sour cherry Juice consumption on the elderlies Sleep Quality
Public title
The Effect of sour cherry Juice consumption on the elderlies Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in the study
age over 60
obtaining a score of at least 7 from the short-term cognitive questionnaire,
having at least one of the seven disturbing items in sleep quality based on the Pittsburgh's questionnaire
having written consent to participate in the research
having the ability to communicate with the researcher
Exclusion criteria:
Refusal to continue to participate in the study and collaborate with the researcher
having acute illness or hospitalization during the study which prevents keep working
not using cherry juice or placebo for any reason more than 20% of the recommended or recommended dose,
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
120
Actual sample size reached:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of individuals will be made available on the basis of the criteria for entering the research. The elderly at this stage are randomly assigned (using spss software) in one of the three intervention, placebo or control
groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to observe blindness, two drops A and B (containing 200 cc of cherry juice or 200 cc of placebo) are prepared that only the pharmacist's
consultant knows about its content
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Committee for Medical Research Ethics in Mashhad on20/08/1396
Street address
NO.17univercity streetMashhad univercity medical science building medical of science
City
Mashhad
Province
Razavi Khorasan
Postal code
91778 -99191
Approval date
2017-11-11, 1396/08/20
Ethics committee reference number
IR.MUMS.REC.1396.275
Health conditions studied
1
Description of health condition studied
quality of sleep in elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep duration
Timepoint
Before intervention - after intervention (day 15) -different after intervention - the thirtieth day
Method of measurement
Using Pittsburgh Sleep Quality Questionnaire
2
Description
waking up during sleepuseful sleep duration
Timepoint
Before intervention - after intervention (day 15) -different after intervention - the thirtieth day
Method of measurement
Using Pittsburgh Sleep Quality Questionnaire
3
Description
daily function
Timepoint
Before intervention - after intervention (day 15) -different after intervention - the thirtieth day
Method of measurement
Using Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 200 cc of natural sour milk from the specified species of cerasus PERONEUS, which has been standardized according to its phenolic compounds in the traditional medicine laboratory of Mashhad, for 15 days at 10-9 nights in the intervention group Will give
Category
Treatment - Other
2
Description
Intervention group 2: providing 200 cc of ordinary water with artificial sugar (its amount will be normal with lemon juice) and a small amount of cherry essential oil at the same time in the placebo group
Category
Placebo
3
Description
Control group: routin care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
center of rehabilitation and keeping toos elderly
Full name of responsible person
enginer sharifniya
Street address
BOULEVARDTOOS-toos 35
City
mashhad
Province
Razavi Khorasan
Postal code
36910552
Phone
+98 51 3691 0364
Fax
Email
feizianAR@mums.ac.ir
Web page address
http://www.iranpronet.com
2
Recruitment center
Name of recruitment center
center of rehabilitation and Keeping Ashiyan mehr
Full name of responsible person
maryam zarif
Street address
Mashhad - BOULEVARD Fakouri - Fakori 17 and 19
City
Mashhad
Province
Razavi Khorasan
Postal code
38943498_051
Phone
+98 51 5252 6858
Fax
Email
feizianAR941@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sayyed reza Mazloom
Street address
Doctora cross road, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3859 1511
Fax
+98 51 3871 3638
Email
p-relation@mums.ac.ir
Web page address
Grant name
reaserch of univercity
Grant code / Reference number
960752
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Abdolraouf feizian
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.30, Eesteghlal St.
City
torbate jam
Province
Razavi Khorasan
Postal code
95731-14415
Phone
+98 51 5252 6858
Fax
+98 51 5252 6858
Email
feizianAR941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raouf feizian
Position
Senior of nursing elderly
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing & Mid Wiferry Faculty, Daneshgah St.,
City
Mashhad
Province
Razavi Khorasan
Postal code
9573114415
Phone
+98 51 3859 1511
Fax
Email
feizianAR941@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abdolraouf feizian
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.30, Esteghlal St.
City
torbate jam
Province
Razavi Khorasan
Postal code
95731-14415
Phone
+98 51 5252 6858
Fax
+98 51 5252 6858
Email
feizianAR941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD