Protocol summary
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Study aim
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Determining the effect of Benson relaxation on the care burden and coping strategies of cancer caregivers
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Design
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The study is a clinical trial with a control group, with a parallel design that was randomly divided into two equal groups with a sample size of 124 caregivers.
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Settings and conduct
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Using convenience sampling, we collect samples from all caregivers of patients who refer to the chemotherapy and radiotherapy wards of Sabzevar Vasei Hospital. Samples are randomly divided into experimental and control groups based on permutation blocks. Sealed and numbered envelopes are used for concealment. Demographic characteristics questionnaire, care pressure and coping strategies are completed by both groups before and after four weeks of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
At least six months of care work
Age between 18 to 67 years
Do not take professional care
Not participating in other research
Greater total caregiver burden score equal to 36
Exclusion criteria:
Neuromuscular disorders
Acute disease or special conditions
Severe mental disorder and the use of sedatives
Occurrence of stressful events
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Intervention groups
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The test group is taught the Benson relaxation technique, then a CD is given to the research units to perform twice a day for four weeks at home. During the study, the intervention group will be followed up by telephone for relaxation and the control group will not receive any intervention, and only due to stressful events and not attending a class or effective stress program based on the times mentioned in The above will be reviewed and caregiver questionnaires and coping strategies will be completed before the study and after four weeks by both groups. Also, the researcher is available to the participants by phone during the study.
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Main outcome variables
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caregiver burden؛ coping strategies
General information
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Reason for update
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Correction of the care burden score in the inclusion criteria and recording the date of onset of the sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210712051849N1
Registration date:
2021-07-13, 1400/04/22
Registration timing:
prospective
Last update:
2023-10-08, 1402/07/16
Update count:
2
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Registration date
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2021-07-13, 1400/04/22
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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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2021-07-18, 1400/04/27
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Expected recruitment end date
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2021-10-22, 1400/07/30
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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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Investigation the effect of benson's relaxation on care burden and coping strategies among caregivers of cancer patients
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Public title
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the effect of benson's relaxation on care burden and coping strategies
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Caring for a cancer patient during the study
Have at least six months of care for a cancer patient
Age of care between 18 to 67 years
Not to be a professional caregiver (not being employed as a health care worker)
Willingness to participate in the study
Have the ability to read and write
Access to the phone to follow the training program
The caregiver obtains the total care pressure score of X≥ 48 based on the score obtained from the questionnaire
Exclusion criteria:
Neuromuscular disorders
Having an acute illness or special condition that requires medical attention
Severe mental disorder and the use of sedatives
Occurrence of stressful events such as the death of a first-degree relative, separation or divorce, and legal disputes in the past six months and during the course of study
hearing and vision disorders (deaf and dumb)
participate in other research by the caregiver during the last 3 months
receive a fee for care
Participate in any classes or programs that affect stress such as relaxation, yoga and meditation
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Age
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From 18 years old to 67 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:
124
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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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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2021-05-10, 1400/02/20
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Ethics committee reference number
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IR.MEDSAB.REC.1400.058
Health conditions studied
1
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Description of health condition studied
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cancer
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ICD-10 code
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C80.0
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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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Care burden of caregivers
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Timepoint
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Before and four weeks after the intervention
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Method of measurement
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Novak and Guest Caregiver burden Questionnaire
2
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Description
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Caregiver coping strategies
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Timepoint
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Before and four weeks after the intervention
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Method of measurement
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Endler and Parker Short Form Coping Questionnaire
Intervention groups
1
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Description
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Intervention group: Benson Relaxation is taught to caregivers as a intervention in a special room in the chemotherapy and radiotherapy wards to fully learn, then a CD is given to them to do benson relaxation in home twice a day in the morning and evening with at least two hours interval for 20 minutes and continue for four weeks. During the study, three days after the training, the members of the intervention group will be followed up by telephone to ask questions about relaxation and to evaluate stressful events during the study, and it will be repeated every seven days. Then, after four weeks, the care burden questionnaires and coping strategies will be completed again .Benson relaxation is done by asking people to lie down in a quiet environment and in a comfortable position, or to sit on a chair and close their eyes, then slowly relax their muscles from the legs to the face. And at the same time breathe in through the nose and be aware of their breathing, and then say the word "one" silently when exhaling. People are advised not to worry if they do not reach a deep level of relaxation and to allow the relaxation to happen at its own pace, to ignore disturbing thoughts and to focus on saying one exhale at a time. When finished, open your eyes and sit for a few minutes, then stand still (they may open their eyes to check for time while relaxing, without using an alarm).
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Category
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Rehabilitation
2
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Description
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Control group: The control group will not receive any intervention and will be reviewed solely for the occurrence of stressful events and failure to attend a class or program affecting stress based on the times mentioned above.
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Category
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Rehabilitation
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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Sabzevar 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Information security of participants
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Study Protocol
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Undecided - It is not yet known if there will be 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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available