Determining the effect of progressive muscle relaxation technique on anxiety and sleep quality in patients with Covid-19
Design
Use blocking method for randomization
Create 6 blocks of 4 such as (AABB, (BBAA) (ABAB), (BABA), (ABBA), (BAAB) combinations, then consider the digits 1 to 6 for each of these combinations. Depending on the sample size, 16 quadruple blocks are randomly selected by placement of 6 designed blocks.
A (intervention group) means: recipient of progressive muscle relaxation technique and B (control group): recipient of the inpatient care method.
Settings and conduct
Location: Kovid ward of Valiasr Fasa hospital. The intervention group will be taught to perform Jacobsen's progressive muscle relaxation technique. Then perform this technique once in the morning and once at night for 20 minutes for 5 consecutive days. During this period, the control group receives only normal care. Completion of questionnaires before and after the intervention in two groups
Participants/Inclusion and exclusion criteria
Entry requirements:
1. Confirmation of Covid-19 infection through laboratory findings and physician diagnosis
2. Having an age range between 65-15
3. Ability to read and write
4. Absence in the acute stage of the disease according to the doctor's diagnosis
5. Do not suffer from mental illness
6. No musculoskeletal disorders
7. Ability to do exercises during the day
Exit conditions:
1. Reluctance to continue cooperation at any stage of the study
2. Worsening disease conditions and the need for mechanical ventilation
3. Do not perform exercises according to the specified schedule
4. Pregnancy
Intervention groups
Intervention group: Jacobsen's progressive muscle relaxation technique. Control group: receive only normal care
Main outcome variables
Anxiety status, sleep quality, quality of life,
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210411050929N1
Registration date:2022-02-25, 1400/12/06
Registration timing:retrospective
Last update:2022-02-25, 1400/12/06
Update count:0
Registration date
2022-02-25, 1400/12/06
Registrant information
Name
samaneh dinari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5336 2724
Email address
dinari821@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
2021-07-05, 1400/04/14
Actual recruitment end date
2021-12-18, 1400/09/27
Trial completion date
2021-12-18, 1400/09/27
Scientific title
The effect of progressive muscle relaxation technique on anxiety and sleep quality in patients with COVID-19
Public title
The effect of relaxation technique on anxiety and sleep quality in patients with COVID-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with COVID-19 admited to Hospital
Absence in the acute stage of the disease according to the doctor's diagnosis
No musculoskeletal disorders
Exclusion criteria:
Worsening disease conditions and the need for mechanical ventilation
Pregnancy
عدم تمایل به ادامه همکاری
Do not do the technique according to the plan
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Actual sample size reached:
59
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking method
In the blocking method, first six blocks of four sizes are created, such as combinations such as (AABB, (BBAA) (ABAB), (BABA), (ABBA), (BAAB), then for each of these combinations four One of the digits will be considered from 1 to 6. In the next step, according to the sample size, 16 blocks of four will be selected randomly by placing 6 of the designed blocks.
In randomized allocation by blocking method, the meaning of A (intervention group): the recipient of progressive muscle relaxation technique and B (control group): the recipient of the common care method of the hospital ward.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Imam Hossein Boulevard - Hormozgan University of Medical Sciences Campus Complex
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-04-26, 1400/02/06
Ethics committee reference number
IR.HUMS.REC.1400.031
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Spielberger State-Trait Anxiety Inventory
Timepoint
Before the intervention _ Day 5, end of the intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory (STAI)
2
Description
sleep quality
Timepoint
Before the intervention _ Day 5, end of the intervention
Method of measurement
Verran and Snyder-Halpern Sleep ( ScaleVSH Sleep Scale)
Secondary outcomes
1
Description
no
Timepoint
no
Method of measurement
no
Intervention groups
1
Description
Intervention group: progressive muscle relaxation technique .Patients perform the Jacobsen Progressive Muscle Relaxation Technique, which they are trained in in one session, for 5 consecutive days in the morning and evening for 20-30 minutes.
Category
Rehabilitation
2
Description
Control group: dont the progressive muscle relaxation technique .This group receives only the usual care of the ward.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-¬Asr Hospital in Fasa
Full name of responsible person
Samaneh Dinari
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5331 5024
Email
info@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymoor Aghamolaei
Street address
Imam Hossein Square - Hormozgan University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
info@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Samaneh Dinari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No87.20alley.khezri ave.faz 5.FASA.FARS
City
Fasa
Province
Fars
Postal code
7461466584
Phone
+98 71 5336 2724
Fax
Email
dinari821@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Samaneh Dinari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No87.20alley.khezri ave.faz 5.FASA.FARS
City
Fasa
Province
Fars
Postal code
7461466584
Phone
+98 71 5336 2724
Fax
Email
dinari821@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Samaneh Dinari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No87.20alley.khezri ave.faz 5.FASA.FARS
City
Fasa
Province
Fars
Postal code
7461466584
Phone
+98 71 5336 2724
Fax
Email
dinari821@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Only part of the data can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers of medical universities
Under which criteria data/document could be used
Protect the moral and legal rights of the author and publisher
From where data/document is obtainable
dinari821@gmail.com
What processes are involved for a request to access data/document