Protocol summary
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Study aim
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The effect of Benson’s relaxation technique on depression, anxiety and quality of life of caregivers of patients with cancer
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Design
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A non-blind controlled randomized trial with a parallel design will be conducted on two groups of 25 subjects.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Depression, anxiety, and quality of life.
General information
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Reason for update
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An error has occurred in the recruitment dates.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100403003618N7
Registration date:
2019-07-04, 1398/04/13
Registration timing:
registered_while_recruiting
Last update:
2020-04-26, 1399/02/07
Update count:
1
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Registration date
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2019-07-04, 1398/04/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-06-22, 1398/04/01
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Expected recruitment end date
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2019-12-21, 1398/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of Benson’s relaxation technique on depression, anxiety, and quality of life of caregivers
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Purpose
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Other
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Inclusion/Exclusion criteria
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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.
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Age
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From 20 years old to 59 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-10, 1398/03/20
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Ethics committee reference number
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IR.KAUMS.NUHEPM.REC.1398.013
Health conditions studied
1
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Description of health condition studied
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Depression
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ICD-10 code
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F32.0
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ICD-10 code description
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Major depressive disorder, single episode, mild
2
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Description of health condition studied
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Anxiety
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ICD-10 code
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F41.1
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ICD-10 code description
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Generalized anxiety disorder
3
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Description of health condition studied
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Quality of life
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ICD-10 code
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C80
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ICD-10 code description
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Malignant neoplasm without specification of site
Primary outcomes
1
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Description
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Depression
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Timepoint
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Before the intervention, the end of the sixth week of intervention, and also four weeks after the end of the intervention.
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Method of measurement
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The Beck Depression Inventory
2
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Description
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Anxiety
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Timepoint
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Before the intervention, the end of the sixth week of intervention, and also four weeks after the end of the intervention.
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Method of measurement
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The Spilberger Inventory
Secondary outcomes
1
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Description
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Quality of life
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Timepoint
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Before the intervention, the end of the sixth week of intervention, and also four weeks after the end of the intervention.
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Method of measurement
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The Caregiver Quality Of Life index-Cancer scale
Intervention groups
1
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Description
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Intervention group: Benson's relaxation technique will be performed once a day (20 minutes) for six weeks.
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Category
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Behavior
2
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Description
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Control group: The control group will not receive intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Not decided yet.
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When the data will become available and for how long
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Not decided yet.
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To whom data/document is available
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Not decided yet.
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Under which criteria data/document could be used
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It has not been decided yet.
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From where data/document is obtainable
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Not decided yet.
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What processes are involved for a request to access data/document
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Not decided yet.
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Comments
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