A comparative study of the effect of sleep hygiene program training and foot reflexology massage on the quality of sleep and quality of life of the elderly: a randomized controlled clinical trial study
Comparison of the effect of sleep hygiene training and foot reflexology massage on the quality of sleep and quality of life of the elderly referring to day care centers in Sari city in 2014
Design
Clinical trial with control group, with intervention groups 1 and 2, randomized, on 120 patients. Envelopes will be used for randomization.
Settings and conduct
The intervention will be carried out in daily care centers for the elderly in Sari city, and a group of 40 people will receive sleep hygiene training, and a group of 40 people will also receive foot massage, and a group of 40 people will be the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Having a calendar age of 60 years and older and living in Sari city, having sleep problems (sleep quality score more than 5), being able to communicate, getting a score of 7 (seven) or more in the AMT cognitive test, not having a history of psychosis according to the diagnosis of a specialist doctor. No complications in the legs such as fractures, wounds and skin, sensory and movement disorders and written informed consent to participate in the desired courses and visit the center daily for at least the last three months and the procedure is not harmful for the elderly according to the diagnosis of the center doctor.
Exclusion criteria
Intolerance and restlessness and anxiety of the elderly, hospitalization, absence of more than two sessions, occurrence of complications or disorder or special disease during the last month during the study process.
Intervention groups
Sleep health education intervention group
Foot reflex massage intervention group
control group
Main outcome variables
Quality of life؛Quality of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221106056420N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Mohammad Taha Saadati Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 9074
Email address
m.saadatirad@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-07, 1402/06/16
Expected recruitment end date
2023-10-30, 1402/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of sleep hygiene program training and foot reflexology massage on the quality of sleep and quality of life of the elderly: a randomized controlled clinical trial study
Public title
A comparative study of the effect of sleep hygiene program training and foot reflexology massage on the quality of sleep and quality of life of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a calendar age of 60 years and older
living in Sari city,
having sleep problems (sleep quality score more than5
being able to communicate
getting a score of 7 (seven) or more in the AMT cognitive test
not having a history of psychosis according to the diagnosis of a specialist doctor
No complications in the legs such as fractures, wounds and skin, sensory and movement disorders
written informed consent to participate in the desired courses
visit the center daily for at least the last three months
the procedure is not harmful for the elderly according to the diagnosis of the center doctor
Exclusion criteria:
The presence of skin problems and wounds in the legs
Inability to communicate
Having a cognitive problem
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to three control and intervention groups using a 3-way block method (using sealed opaque envelopes). In this way, 120 envelopes contain 3 ABC codes (code A for massage intervention, code B for training intervention and code C for the control group) will be prepared. 40 envelopes will be prepared from each of the 6 cases of random placement of these letters together, and they will be randomly selected by lottery. Intervention and control groups will be allocated.
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
Research Ethics Committee of Mazandaran University of Medical Sciences
Street address
Research Assistant, Moalem Square, Mazandaran University of Medical Sciences, Mazandaran, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
0000000000
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.MAZUMS.REC.1402.317
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
Quality of Sleep
Timepoint
Before the intervention, after the end of the intervention, one month after the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Quality of life
Timepoint
Before the intervention, after the end of the intervention, one month after the end of the intervention
Method of measurement
Lipad Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1 : Sleep hygiene education: The education will be held in groups of two to five people at the daily care centers in Sari. The duration of the training session is an average of one hour, which will be provided by the researcher. The teaching method will be lecture, group discussion and question and answer. Educational aids such as video projectors, slides, and pamphlets will contain pictures of the principles of sleep hygiene. In this session, the educational content includes the importance of sleep in the life of the elderly, changes in sleep during old age, and the sleep hygiene program (including nutrition, activity, sleep environment, setting the schedule). Sleep will be provided for the elderly. At this stage, the educational pamphlet, which will contain the above issues and will be prepared using authentic books and articles, will be provided to the elderly. If the elderly are illiterate, the experts will prepare the educational pamphlet for the elderly. The elderly read
Category
Rehabilitation
2
Description
Intervention group2: Foot reflex massage: To implement reflex foot massage intervention, the researcher after fully explaining the procedure and obtaining informed consent, it is performed for 30 minutes on both feet (15 minutes for each foot) and during 3 sessions. All interventions are performed by the researcher.
Category
Treatment - Other
3
Description
Control group: does not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarai Mehr Day Care Center for the Elderly
Full name of responsible person
Asghar Nourozi
Street address
6 Imam Reza Street, Imam Reza Street, Serai Mehr Center
City
Sari
Province
Mazandaran
Postal code
1234567890
Phone
+98 911 353 9077
Email
Asg.noruzi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahim Nezahad
Street address
Sari, Moalem Square
City
Sari
Province
Mazandaran
Postal code
1234567890
Phone
+98 11 3448 4854
Email
Research@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Ehteram Sadat Ilali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Sari, Moalem Square
City
Sari
Province
Mazandaran
Postal code
1234567890
Phone
+98 11 3448 4850
Email
Paradis2082000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ehteram Sadat ilali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Sari, Moalem Square
City
Sari
Province
Mazandaran
Postal code
1234567890
Phone
+98 11 3448 4850
Email
Saadatirad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Taha Saadati Rad
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sari, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4817875931
Phone
+98 11 3311 9074
Email
Saadatirad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document