Investigating the effectiveness of psychological education of the patient and spouse in people with obstructive sleep apnea following the CPAP device, improving sleep quality and reducing daily sleepiness
Investigating the effectiveness of psychological education of the patient and spouse in people with obstructive sleep apnea following the CPAP device, improving sleep quality and reducing daily sleepiness.
Design
A clinical trial with a control and intervention group, a blinded strain, Randomized
Settings and conduct
The place of the study is in the sleep clinic of Ibn Sina Hospital, and the patients are not aware of the research process
Participants/Inclusion and exclusion criteria
A patient with obstructive sleep apnea
Patients who want to use a CPAP machine
Completing questionnaires related to sleep quality and daily sleepiness
Marital status
Intervention groups
the control group will have self-monitoring for 5 weeks. Intervention group meetings will be in person or online. Psychological training sessions using cognitive behavioral approach (CBT).1.Diagnostic interview based on DSM-5 for each participating member with an approximate time of 45 minutes in one session (diagnosis of severe mental illnesses)2. Psychoeducation about the nature of the disease in one session to the patient and spouse and motivational interview.At first, clients are taught a complete explanation about the content of obstructive sleep apnea, the CPAP machine, and the consequences and complications of not using the machine.This training can be in the form of slides and different types of educational videos. Such information about daily sleep quality and daily sleepiness will also be provided to patients.
Main outcome variables
Adherence to the CPAP device
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240203060885N1
Registration date:2024-02-20, 1402/12/01
Registration timing:registered_while_recruiting
Last update:2024-02-20, 1402/12/01
Update count:0
Registration date
2024-02-20, 1402/12/01
Registrant information
Name
Mahdiye Faramarzi Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 991 073 6552
Email address
faramarzimahdiye01@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-13, 1402/11/24
Expected recruitment end date
2024-04-12, 1403/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of psychological education of the patient and spouse in people with obstructive sleep apnea following the CPAP device, improving sleep quality and reducing daily sleepiness
Public title
Investigating the effectiveness of psychological education of the patient and spouse in people with obstructive sleep apnea following the CPAP device, improving sleep quality and reducing daily sleepiness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with obstructive sleep apnea
patients who want to use CPAP device
completing questionnaires related to sleep quality and daily sleepiness
marriage
Exclusion criteria:
suffering from severe mental illnesses (psychotic, bipolar)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation blocks method was used to generate the sequence of random assignment of people to the studied groups. Random allocation sequence of people was done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups.
In this study, there are six blocks AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5) and BAAB (6). One of the blocks is randomly selected. If the first block, AABB, is selected, the first and second people are assigned to group A, and the third and fourth people are assigned to group B, and this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in this research do not know about the sampling method and the members of the control group and only receive the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
East Hedayat St., Hedayat 2.1, plauqe. 83, second floor
City
Mashhad
Province
Razavi Khorasan
Postal code
9194873999
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.477
Health conditions studied
1
Description of health condition studied
Patients with obstructive sleep apnea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnea
Primary outcomes
1
Description
Patients with obstructive sleep apnea who use a CPAP machine
Timepoint
The measurement is done before the start of the intervention, immediately after the end of the intervention and eight weeks after the intervention
Method of measurement
Using the Petersburg Sleep Quality Questionnaire and Epworth Daily Sleepiness Questionnaire
Secondary outcomes
1
Description
improving sleep quality
Timepoint
The measurement is done before the start of the intervention, immediately after the end of the intervention and eight weeks after the intervention
Method of measurement
Using the Petersburg Sleep Quality Questionnaire and the Epworth Daily Sleepiness Questionnaire
2
Description
reducing daily sleepiness
Timepoint
The measurement is done before the start of the intervention, immediately after the end of the intervention and eight weeks after the intervention
Method of measurement
Using the Petersburg Sleep Quality Questionnaire and the Epworth Daily Sleepiness Questionnaire
Intervention groups
1
Description
Intervention group: This group includes 17 patients with their partner, the affected patient has used the CPAP machine for one month, and after one month, intervention sessions (5 sessions) will be held for each person in person or online.The content of the sessions will be based on the cognitive-behavioral approach. In this way, one session of psychoeducation, two sessions of working on false beliefs of the patient and partner about apnea and the use of (cognitive) device, and two sessions will be behavioral.After finishing the sessions, the patient will use the device again for one month to determine the effectiveness of the intervention sessions.
Category
N/A
2
Description
Intervention group: This group includes 17 patients without a partner, the affected patient has used the CPAP machine for one month, and after one month, intervention sessions (5 sessions) will be held for the patient in person or online. The content of the sessions will be based on the cognitive-behavioral approach.In this way, one session of psychoeducation, two sessions of working on the patient's false beliefs about apnea and the use of the (cognitive) device, and two sessions will be behavioral. After finishing the sessions, the patient will use the device again for one month to determine the effectiveness of the intervention sessions.
Category
N/A
3
Description
Control group: The control group includes 17 patients along with their partner, the affected patient used the CPAP machine for one month, and after one month, all the content related to the intervention sessions was given to the patient and partner in the form of brochures without conducting the sessions. to be read weekly. After five weeks, the patient will use the device again for one month to determine the effectiveness of the intervention sessions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital, Mashhad
Full name of responsible person
Dr. Seyed Kaveh Hojjat
Street address
Second floor, No. 83, Hedayat 2/1, East Hedayat St
City
Mashhad
Province
Razavi Khorasan
Postal code
9194873999
Phone
+98 991 073 6552
Email
Faramarzimahdiye01@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Mouhebati
Street address
University Street, next to Hoizeh Cinema, University of Medical Sciences, 3rd floor, University Research and Technology Vice-Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
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
Mahdiye Faramarzi Moghaddam
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hedayat St., 2.1 Hedayat, No. 83, second floor
City
Mashhad
Province
Razavi Khorasan
Postal code
9194873999
Phone
+98 991 073 6552
Email
Faramarzimahdiye01@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdiye Faramarzi Moghaddam
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hedayat St., 2.1 Hedayat, No. 83, second floor
City
Mashhad
Province
Razavi Khorasan
Postal code
9194873999
Phone
+98 991 073 6552
Email
faramarzimahdiye01@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdiye Faramarzi Moghaddam
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hedayat St., 2.1 Hedayat, No. 83, second floor
City
Mashhad
Province
Razavi Khorasan
Postal code
9194873999
Phone
+98 991 073 6552
Email
faramarzimahdiye01@gmail.com
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