Effectiveness of occupation-based occupational therapy interventions in managing sleep quality of COVID-19 recovered patients with sleep quality disorders in three areas: person, environment, and occupation
Design
This is a double-blind randomized clinical trial with the comparison group, in which 86 eligible patients will be randomly assigned through block randomization to the intervention and the control groups
Settings and conduct
This study will conduct with counseling sessions and the educational package of occupation-based and sleep health interventions in a double-blind manner( the participant and the researcher and the outcome assessor are blind) in Hamedan Red Crescent, Occupational Therapy Clinic in Nahavand city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
At least one month and at most three months have passed since COVID-19 was positive
Based on the Mini-Mental State Examination score of 23 and above
Have a sleep disorder based on the Petersburg questionnaire and get a score higher than 5
Exclusion criteria:
Reluctance to attend study
Occurrence of stresses such as recurrence of COVID-19
Intervention groups
1. Intervention group: Sleep management occupational therapy interventions in 15 sessions of 30 minutes over one month
2. Control group: Common sleep hygiene tips in one session
Main outcome variables
Quality of sleep
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20210821052244N1
Registration date:2023-03-06, 1401/12/15
Registration timing:registered_while_recruiting
Last update:2023-03-06, 1401/12/15
Update count:0
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
saideh sadat mortazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1572
Email address
s.mortazavi.ot@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-04-18, 1402/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of occupation-based interventions in improving sleep quality of patients recovered from COVID-19
Public title
Occupational therapy interventions in sleep quality
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having reading and writing skills
At least one month and at most three months have passed since COVID-19 was positive
Body mass index between 18.5 to 27
25 -50 years old
An acceptable level of cognitive function, i.e. a score of equal or greater than 23 on the Mini-Mental State Examination
Pittsburgh Sleep Quality Index≥5
Without known chronic diseases such as Progressive Neurological Disorders, Multiple Sclerosis, and Acute Cancer
Exclusion criteria:
Reluctance to attend study
Alcohol or drug abuse
Being menopausal
Pregnant females
Age
From 25 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 University of Social Welfare and Rehabilitation Sciences
Street address
Velenjak, Daneshjoo Blvd, Koodakyar ave., University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
6591616563
Approval date
2022-05-18, 1401/02/28
Ethics committee reference number
IR.USWR.REC.1401.009
Health conditions studied
1
Description of health condition studied
Sleep disorder
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
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
2
Description
Subjective quality of sleep
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
Secondary outcomes
1
Description
Sleep duration
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
2
Description
Sleep latency
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
3
Description
Sleep onset and maintenance
Timepoint
Before the intervention, one week after the intervention, one month after the intervention
Method of measurement
Petersburg Sleep Quality Questionnaire
Intervention groups
1
Description
Intervention group: sleep management occupational therapy interventions in 15 sessions, including 5 sessions per week, will be thirty minutes in the form of 8 individual sessions and 7 training workshop sessions. The content of the sessions includes an introduction to sleep, providing good sleep exercises, teaching behavioral and individual strategies, teaching environmental strategies, and balance in occupation. Meetings are face-to-face, but there will be the possibility of virtual communication and phone calls to answer possible questions.
Category
Rehabilitation
2
Description
Control group: Common sleep hygiene recommendations in one session thirty-minute sessions including setting the clock and sleeping conditions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Headquarters for the fight and prevention of Coronavirus disease (COVID-19) in Hamadan
Full name of responsible person
Saideh Sadat Mortazavi
Street address
Hamadan University of Medical Science, St. Shahid Fahmideh, Hamadan. Iran.