Determining the effects of sleep Health education based on a mobile application on sleep quality of the older adults covered by Rasht state pension fund, 2021.
Design
A semi-experimental study with a control group, parallel groups, randomized, on 96 patients. The sealed Envelope online service was used for randomization.
Settings and conduct
This research is carried out in two stages. The first phase of it is a cross-sectional study with the aim of determining the quality of sleep of 330 people among the elderly referring to the national pension fund of Rasht city. The second phase is a semi-experimental clinical trial that will be implemented with the aim of determining the effect of the educational application on the sleep quality of the elderly on 48 people in two intervention and control groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are: age 60 years or older, not suffering from substance abuse disorder, membership in the Rasht National Pensioners Fund, having minimum reading and writing literacy, willingness to participate in research, ability to use a smartphone, not having memory disorders and cognitive, and having sleep disorders
Intervention groups
Using the random block method, elderly people are divided into two intervention groups under training with the application and a control group.
Intervention group: Face-to-face sessions will be held for one week and two sessions for the intervention group. Then, the elderly people will implement its programs every day for 4 weeks.
Control group: At the end of the study, the research samples in the control group receive all the training in the form of booklets, face-to-face training, and mobile applications.
Main outcome variables
Sleep Quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220926056042N1
Registration date:2022-12-06, 1401/09/15
Registration timing:retrospective
Last update:2022-12-06, 1401/09/15
Update count:0
Registration date
2022-12-06, 1401/09/15
Registrant information
Name
Hannaneh Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3377 8110
Email address
rahimihannaneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of sleep Health education based on a mobile application on the sleep quality of the older adults
Public title
sleep Health education based on mobile application on sleep quality of the older adults
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of the elderly to participate in the study
Age 60 years and older
Not having a substance abuse disorder
Membership in the national pension fund of Rasht city
Having at least reading and writing literacy
Ability to communicate visually and verbally
Ability to use a smartphone
Having a sleep disorder
Absence of memory and cognitive disorders
Exclusion criteria:
Taking sleeping pills
Simultaneously participating in other educational programs and clinical trials and using similar applications
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible people will be divided into two intervention and control groups using the block randomization method with the size of 4 blocks. To generate the randomization list from the online randomization service of Sealed Envelope Ltd. 2019 will be used. (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
In general, the sampling method of the first phase and at the end of the samples in the second phase will be done by simple random and random allocation based on the software.
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 Guilan University of Medical Sciences
Street address
University Research and Technology Vice-Chancellor- in front of 17 Shahrivar Hospital- Shahid Siadati St. -Namjo St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Approval date
2022-09-21, 1401/06/30
Ethics committee reference number
IR.GUMS.REC.1401.322
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
sleep quality
Timepoint
Before the start of the intervention, 5 weeks after the intervention
Method of measurement
Pittsburgh sleep quality index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: an in-person meeting will be held in small groups. Face-to-face intervention sessions will be held in the training class of the pension fund, which has sufficient capacity to comply with health protocols during the 2019 coronavirus epidemic. Face-to-face sessions will be held for one week and two sessions. In the first and second sessions, while getting to know the elderly, and mentioning the study's objectives, the pre-intervention questionnaire will be filled out by the elderly. On the other hand, the intervention group will be taught how to use a mobile-based sleep health educational application. Then, the elderly will run its programs every day for 4 weeks. If they have questions about using the application, they will contact the researcher by phone and receive the necessary instructions. The researcher will follow up by phone twice a week. Also, an educational booklet related to the application is prepared and provided to them.
Category
Behavior
2
Description
Control group: at the end of the study, all educational materials will be implemented for this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
State Pension Fund
Full name of responsible person
Sajjad Mohammadian
Street address
No. 153, Hafez Blvd
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3333 2610
Email
info@cspf.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Naghipour
Street address
Shahid Siyadati St, Namjo St.
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Hanana Rahimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Poursina Crossroads, Hafez Street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 5783
Email
rahimihannaneh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shahla Asiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Porsina Crossroads, Hafez St.
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 5783
Email
shahlaasiri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shahla Asiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Porsina Crossroads, Hafez Street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 5783
Email
shahlaasiri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in multicenter studies with the approval of the author team
From where data/document is obtainable
E-mail
What processes are involved for a request to access data/document
After the request and approval of the authors, the data will be sent within a week.