A clinical trial for determination of the effect of Benson’s relaxation technique on depression, anxiety, and quality of life of caregivers of patients with cancer
The effect of Benson’s relaxation technique on depression, anxiety and quality of life of caregivers of patients with cancer
Design
A non-blind controlled randomized trial with a parallel design will be conducted on two groups of 25 subjects.
Settings and conduct
Among caregivers of patients with cancer referring to Kashan’s Shahid Beheshti Hospital, 50 eligible ones will be assigned into two groups of 25 subjects. The intervention group will perform Benson's relaxation technique, once a day for six weeks. The Beck’s Depression, and the Spielberger's Anxiety Inventories, and the Quality of Life of Cancer Caregivers Questionnaire will be used to evaluate the depression, anxiety, and quality of life at the beginning of the study, at the end of the sixth week, and four weeks after the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Caring for a patient with cancer, age of 20 to 59 years, fluency in the Persian language, signing the informed consent form, not receiving antidepressants and anxiolytics, having a mild or higher degree of anxiety and depression, having no known cognitive impairments. Exclusion criteria: Getting any acute illness requiring medical attention, the occurrence of a critical condition for the caregiver which affect the quality of life, death of a caregiver, and doing the intervention for less than 5 sessions in a week, and decision to withdraw.
Intervention groups
After the participants were trained about the relaxation technique, they will be required to do it for 6 weeks, once daily, for 20 min each time. The subjects must take a comfortable position, close their eyes, breathe deeply and regularly through nostrils, loosen all their muscles from feet to the face, and at the same time whisper some calming words. The control group does not perform the technique.
Main outcome variables
Depression, anxiety, and quality of life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100403003618N7
Registration date:2019-07-04, 1398/04/13
Registration timing:registered_while_recruiting
Last update:2019-07-04, 1398/04/13
Update count:1
Registration date
2019-07-04, 1398/04/13
Registrant information
Name
Mohsen Adib-Hajbaghery
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36155540021
Email address
adibhajbagheri_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial for determination of the effect of Benson’s relaxation technique on depression, anxiety, and quality of life of caregivers of patients with cancer
Public title
The effect of Benson’s relaxation technique on depression, anxiety, and quality of life of caregivers
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Caring for a patient with cancer at the time of the study (i.e. a spouse, a child, a father, or a mother).
Age between 20 and less than 60 years.
Fluency and ability to read and write in Persian language.
Willingness to participate in the study and signing the informed consent form.
Not receiving antidepressants and anxiolytic medications at the beginning of the study.
Having mild or higher anxiety and depression based on Beck’s depression and the Spielberger State-Trait Anxiety Inventories.
Having no known cognitive impairment (to this end, the individual, and the patient will be questioned if any physician made him/her a medical diagnosis of mental disorders such as amnesia and Alzheimer disease?)
Exclusion criteria:
A caregiver’s decision to withdraw from the study.
Getting any acute illness or conditions requiring medical attention during the study.
The occurrence of a critical condition for the caregiver (such as getting an acute illness, being hospitalized, being divorced) so that his/her quality of life is affected.
Doing the recommended intervention for less than 5 sessions in a week.
Death of a caregiver.
Age
From 20 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The permuted blocked randomization method will be used via an online randomizer, to randomly assign 50 caregivers into 12 four-subject and one two subjects blocks to create two groups of 25 subjects.
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
Kashan University of Medical Sciences
Street address
Ravand Street, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2019-05-21, 1398/02/31
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1398.013
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
3
Description of health condition studied
Quality of life
ICD-10 code
C80
ICD-10 code description
Malignant neoplasm without specification of site
Primary outcomes
1
Description
Depression
Timepoint
Before the intervention, the end of the sixth week of intervention, and also four weeks after the end of the intervention.
Method of measurement
The Beck Depression Inventory
2
Description
Anxiety
Timepoint
Before the intervention, the end of the sixth week of intervention, and also four weeks after the end of the intervention.
Method of measurement
The Spilberger Inventory
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention, the end of the sixth week of intervention, and also four weeks after the end of the intervention.
Method of measurement
The Caregiver Quality Of Life index-Cancer scale
Intervention groups
1
Description
Intervention group: Benson's relaxation technique will be performed once a day (20 minutes) for six weeks.
Category
Behavior
2
Description
Control group: The control group will not receive intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohammad Reza Fazel
Street address
Shahid Beheshti Hospital, Ravand Street, Kashan
City
Kashan
Province
Isfehan
Postal code
87159_81151
Phone
+98 31 5554 3676
Email
beheshtihospital@kaums.ac.ir
Web page address
http://beheshti.kaums.ac.ir/
2
Recruitment center
Name of recruitment center
Yasrebi subspecialty hospital
Full name of responsible person
Dr. Mostafa Sarvizadeh
Street address
Ravand road
City
Kashan
Province
Isfehan
Postal code
1518718311
Phone
+98 31 5558 5000
Email
info@yasrebihospital.ir
Web page address
http://yasrebihospital.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Ravand Street, Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5555 4299
Email
reaserch@kaums.ac.ir
Web page address
http://research.kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Bahareh Ebrahimi
Position
Master of Science Student in Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan
City
Kashan
Province
Isfehan
Postal code
81537-14411
Phone
+98 31 5552 3879
Email
bahar.nurse.2015@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Adib-Hajbaghery
Position
Professor, PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5554 0021
Email
adib1344@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Bahareh Ebrahimi
Position
Master of Science Student in Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan
City
Kashan
Province
Isfehan
Postal code
81537-14411
Phone
+98 31 5255 3879
Email
bahar.nurse.2015@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
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
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
Not applicable
Title and more details about the data/document
Not decided yet.
When the data will become available and for how long
Not decided yet.
To whom data/document is available
Not decided yet.
Under which criteria data/document could be used
It has not been decided yet.
From where data/document is obtainable
Not decided yet.
What processes are involved for a request to access data/document