Determining the effect of Benson Relaxation Virtual Training on Illness Anxiety Disorder in Informal Caregivers of COVID-19 Patients
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, on 60 caregivers. R software was used for randomization.
Settings and conduct
The study site is Vasei Hospital in Sabzevar, where the caregivers of patients with COVID-19 who have been discharged from the hospital during the past two weeks are studied, and in this study, no blinding was performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The age between 18-65 years;
not having a professional caregiver;
health anxiety score greater than or equal to 20;
Exclusion criteria:
Infected to acute COVID-19;
Severe mental disorder;
Neuromuscular disorders
Intervention groups
The control group will not receive any intervention, but the intervention group will receive Benson's relaxation training pamphlet along with the relaxation audio file via messengers. Individuals are then asked to continue the relaxation technique twice a day for three weeks, and both groups will be followed up by telephone.
Main outcome variables
Illness Anxiety Disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051849N2
Registration date:2021-08-21, 1400/05/30
Registration timing:registered_while_recruiting
Last update:2021-08-21, 1400/05/30
Update count:0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
Hamid Barghbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4501 3452
Email address
hamidbarghbani75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of virtual benson's relaxation training on illness anxiety disorder in informal caregivers of COVID-19 patients
Public title
The effect of Benson relaxation on illness anxiety disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years old
Willingness to participate in the study
Having the ability to read and write
Access to smartphones and the Internet and how to use messengers
Not having a professional caregiver (not working as a health care worker)
The caregiver obtains a health anxiety score greater than or equal to 20 based on the score obtained from the questionnaire.
Exclusion criteria:
Infected to active COVID-19
Being addict
Having hearing and vision impairment
Participate in any classes or programs that affect stress such as relaxation, yoga and meditation
Neuromuscular disorders
Having an acute illness or special condition that requires medical attention
Severe mental disorder (schizophrenia, schizoaffective, bipolar) and use of sedatives
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available method and will be placed in intervention and control groups using random allocation permutation blocks. R software will be used to obtain the blocks. In this way, the control group is marked with the letter a and the intervention group with the letter b, and the size of each block is 4 people, the number of blocks is 31 and the number of possible permutations is 6. Then, from the table of random numbers, 31 random numbers are selected. And we fill 31 blocks of scenarios. For example, if block 1 is baba, from the left, the first person will enter the intervention group, the second person will enter the control group, the third person will enter the intervention group, and finally the fourth person will enter the control group.
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 Sabzevar University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Campus of the University of Medical Sciences, above the Memorial of the Shohadaye-e-Gomnam, Shohadaye-e-Hasteea Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2021-07-25, 1400/05/03
Ethics committee reference number
IR.MEDSAB.REC.1400.063
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Illness Anxiety Disorders
Timepoint
Before and three weeks after the intervention
Method of measurement
Health Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive Benson's relaxation training pamphlet along with the relaxation audio file via messengers. Individuals are then asked to perform the relaxation technique twice a day, in the morning and in the afternoon, at least two hours apart, for 20 minutes at a time, and continue to do so for three weeks. During the study, three days after the allocation, the intervention group undergo telephone follow-up to ask for relaxation, which will be repeated every seven days (10th and 17th days). In this training, people are asked to lie down in a quiet environment and in a comfortable position or to sit on a chair and close their eyes, then relax their muscles gently from the legs to the face and at the same time while breathing; breathe through their nose and be aware of their breathing, then say the word "one" silently as they exhale.
Category
Prevention
2
Description
Control group: The control group will not receive any intervention and will be reviewed solely for not attending a class or stress program based on the times mentioned above.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei educational and medical center
Full name of responsible person
Mostafa Rad
Street address
Vasei Hospital, Tohidshahr Boulevard, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8308
Email
mostafarad633@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Hossein Saghi
Street address
Vice Chancellor for Research and Technology, Campus of the University of Medical Sciences, above the Memorial of the Shohadaye-e-Gomnam, Shohadaye-e-Hasteei Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8101
Email
vc.Research@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Hamid Barghbani
Position
Master student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Shohadaye-e-Gomnam , Shohadye-e-Hasteei Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9654135121
Phone
+98 51 4501 3452
Email
hamidbarghbani75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mustafa Rad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Shohadaye-e-Gomnam, Shohadaye Hasteei Boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8308
Email
mostafarad633@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hamid Barghbani
Position
Master student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Shohadaye-e-Gomnam, Shohadaye-e-HasteeiBoulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
Nuclear Martyrs Boul
Phone
+98 51 4501 3452
Email
hamidbarghbani75@gmai.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information security of participants
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