Comparison of diaphragmatic relaxation training and cognitive-behavioral therapy on sleep quality of the elderly referred to comprehensive health centers in Rafsanjan in 1400-1401
Design
75 eligible seniors will be divided into 3 groups (two intervention groups and one control group) using a simple random division method using a random number table, and the type of intervention will be determined again by random division.
Settings and conduct
On the elderly with sleep disorders referred to health centers in Rafsanjan, cognitive therapy intervention is performed in groups in the School of Nursing and diaphragmatic breathing is performed in groups for one session in the faculty and the project is continued in the elderly home.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Having an age above 60 years 2- Having a suitable level of cognitive function 3- Having the ability to read and write 4- Complete mastery of Persian language 5- Having written consent to participate in research 6- Having sleep disorders based on getting a score higher than 5 in the questionnaire Pittsburgh Exclusion criteria: 1 - unwillingness to continue cooperation 2 - deterioration of the patient's physical condition so that he can not cooperate
Intervention groups
Cognitive-behavioral therapy intervention is provided for 4 weeks (2 sessions of 60 minutes per week) under the supervision of a qualified instructor. Diaphragmatic breathing intervention group is invited to the faculty to practice a session in person and they are given practice. And the implementation of the plan is done by them at home. The control group will be explained in the Whats App group for 4 weeks about the problems that will be created in the aging process. The sleep quality of all participants in the study will be measured before, immediately and one month after the intervention.
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N26
Registration date:2022-11-13, 1401/08/22
Registration timing:retrospective
Last update:2022-11-13, 1401/08/22
Update count:0
Registration date
2022-11-13, 1401/08/22
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-07, 1400/12/16
Expected recruitment end date
2022-05-06, 1401/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the diaphragmatic relaxation training and cognitive-behavioral therapy on sleep quality of the elderly
Public title
Comparing the diaphragmatic relaxation training and cognitive-behavioral therapy on sleep quality of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 60 years old
Having an appropriate level of cognitive function (minimum score of 8 in the shortened cognitive test)
Having the ability to read and write
Complete mastery of Persian language
Having the written consent to participate in the research
Sleep disturbance based on getting a score higher than 5 in the Pittsburgh questionnaire
Exclusion criteria:
Not wanting to continue cooperation
Deterioration of the patient's physical condition so that he is unable to cooperate
Start taking sleeping pills
Performing exercises and other interventions that affect the quality of sleep
Foot of the patient
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the framework of the samples, the data will be divided between 3 blocks A, B, C with the help of block randomization based on gender and age, in such a way that the first data in one of the 3 groups will be divided by a simple random method and using the software "Random allocation software" are selected and in the next 2 groups, the data is allocated in the same way based on the software. After equal allocation of data to 3 groups, treatment methods were written on 3 separate sheets and one method was assigned to each of the groups by lottery.
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 Rafsanjan University of Medical Sciences
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2022-02-23, 1400/12/04
Ethics committee reference number
IR.RUMS.REC.1400.252
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Sleep quality score of PSQI questionnaire
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Elderly Sleep Quality Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive-behavioral therapy intervention according to the instructions of Morin CM, Espie CA booklet for 4 weeks (2 sessions of 60 minutes per week) under the supervision of a qualified instructor (having work experience in psychological interventions with the elderly, including cognitive-behavioral therapy) A group is presented in the classroom to ensure the correct implementation of the work method. Meetings are performed with individual assignments (checklist for intervention at home) and the last 10 minutes of each session are spent reviewing reports related to these assignments and answering questions.
Category
Treatment - Other
2
Description
Diaphragmatic breathing intervention group is invited to the faculty to practice a session in person and is practiced by the student (who has received the necessary permission to perform this intervention) through oral training, educational clips and pamphlets. After the end of the first session, the student will be evaluated one by one to ensure the correct implementation, and the implementation of the plan will be continued by them at home for 30 days and the student will be followed by a daily phone call to perform the procedure correctly and continuously. According to the LEE study, patients are advised to sit comfortably in a chair 30 minutes before bedtime, with one hand on the chest and the other on the abdomen with the knees bent and the shoulders relaxed. They are then asked to breathe slowly through their nose so that their abdomen moves up in front of their hands. The hand on the chest should be as stable as possible. During the exhalation phase, the patient should tighten the abdominal muscles and exhale slowly through the pursed lips. This exercise should be performed for 20 minutes every night before bed.
Category
Treatment - Other
3
Description
Control group: The control group will be formed by the Whats App group for 4 weeks by the researcher and will explain the problems that will occur in the aging process and will answer their medical questions and problems.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service centers in Rafsanjan
Full name of responsible person
Dr.Tayebeh Mirzaei
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
RAFSANJAN
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Reza Vazirinejad
Street address
Emam َ Ali blvd
City
RAFSANJAN
Province
Kerman
Postal code
7718174715
Phone
+98 34 3131 5075
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
t.mirzaei@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebe Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Tayebe Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34255900
Email
t.mirzaei@rums.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