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General information
2021-07-21, 1400/04/30
2021-07-18, 1400/04/27
2021-07-2118 00:00:00
empty
Correction of the care burden score in the inclusion criteria and recording the date of onset of the sampling
Correction of the care burden score in the inclusion criteria and recording the date of onset of the sampling
empty
تصحیح نمره ی مراقبتی در معیارهای ورود و ثبت تاریخ شروع بیمارگیری تحقق یافته
تصحیح نمره ی مراقبتی در معیارهای ورود و ثبت تاریخ شروع بیمارگیری تحقق یافته
Caring for a cancer patient during the study
Have at least six months of care for a cancer patient
Do not receive a fee for care
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
Failure to participate in other research by the caregiver during the last 3 months
Do not participate in any classes or programs that affect stress such as relaxation, yoga and meditation
Lack of hearing and vision disorders (deaf and dumb)
The caregiver obtains the total care pressure score of X≥ 36 based on the score obtained from the questionnaire
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
Caring for a cancer patient during the study Have at least six months of care for a cancer patient Do not receive a fee for care 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 Failure to participate in other research by the caregiver during the last 3 months Do not participate in any classes or programs that affect stress such as relaxation, yoga and meditation Lack of hearing and vision disorders (deaf and dumb) The caregiver obtains the total care pressure score of X≥ 3648 based on the score obtained from the questionnaire
برعهده داشتن مراقبت از بیمار مبتلا به سرطان در زمان مطالعه
حداقل شش ماه کار مراقبت از بیمار مبتلا به سرطان را داشته باشد
بابت مراقبت هزینه ای دریافت نکند
سن مراقب بین 18 تا 67 سال
مراقب حرفه ای نباشد (عدم اشتغال به عنوان پرسنل بهداشتی و درمانی)
تمایل به شرکت در مطالعه
توانایی خواندن و نوشتن داشته باشد
دسترسی به تلفن برای پیگیری برنامه ی آموزشی
عدم شرکت در پژوهش های دیگر توسط مراقب طی 3 ماه اخیر
عدم شرکت در هر گونه کلاس ها یا برنامه های تاثیرگذار بر استرس مثل آرام سازی، یوگا و مدیتیشن
عدم اختلال شنوایی و بینایی (کری و لالی)
مراقب نمره ی فشار مراقبتی کل بزرگتر مساوی 36 را بر اساس نمره ی حاصل از پرسشنامه کسب کند
برعهده داشتن مراقبت از بیمار مبتلا به سرطان در زمان مطالعه
حداقل شش ماه کار مراقبت از بیمار مبتلا به سرطان را داشته باشد
سن مراقب بین 18 تا 67 سال
مراقب حرفه ای نباشد (عدم اشتغال به عنوان پرسنل بهداشتی و درمانی)
تمایل به شرکت در مطالعه
توانایی خواندن و نوشتن داشته باشد
دسترسی به تلفن برای پیگیری برنامه ی آموزشی
مراقب نمره ی فشار مراقبتی کل بزرگتر مساوی 48 را بر اساس نمره ی حاصل از پرسشنامه کسب کند
برعهده داشتن مراقبت از بیمار مبتلا به سرطان در زمان مطالعه حداقل شش ماه کار مراقبت از بیمار مبتلا به سرطان را داشته باشد بابت مراقبت هزینه ای دریافت نکند سن مراقب بین 18 تا 67 سال مراقب حرفه ای نباشد (عدم اشتغال به عنوان پرسنل بهداشتی و درمانی) تمایل به شرکت در مطالعه توانایی خواندن و نوشتن داشته باشد دسترسی به تلفن برای پیگیری برنامه ی آموزشی عدم شرکت در پژوهش های دیگر توسط مراقب طی 3 ماه اخیر عدم شرکت در هر گونه کلاس ها یا برنامه های تاثیرگذار بر استرس مثل آرام سازی، یوگا و مدیتیشن عدم اختلال شنوایی و بینایی (کری و لالی) مراقب نمره ی فشار مراقبتی کل بزرگتر مساوی 3648 را بر اساس نمره ی حاصل از پرسشنامه کسب کند
- 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
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
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
- 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 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
- اختلالات عصبی عضلانی
- ابتلا به بیماری حاد یا شرایط خاصی که به مراقبت پزشکی نیاز داشته باشد
- اختلال روانی شدید و استفاده از داروهای آرامبخش
- بروز وقایع استرس زا مثل مرگ فامیل درجه یک، جدایی یا طلاق و درگیری در مسائل حقوقی در شش ماه گذشته
اختلالات عصبی عضلانی
ابتلا به بیماری حاد یا شرایط خاصی که به مراقبت پزشکی نیاز داشته باشد
اختلال روانی شدید و استفاده از داروهای آرامبخش
بروز وقایع استرس زا مثل مرگ فامیل درجه یک، جدایی یا طلاق و درگیری در مسائل حقوقی در شش ماه گذشته
اختلال شنوایی و بینایی (کری و لالی)
شرکت در پژوهش های دیگر توسط مراقب طی 3 ماه اخیر
دریافت هزینه برای مراقبت
شرکت در هر گونه کلاس ها یا برنامه های تاثیرگذار بر استرس مثل آرام سازی، یوگا و مدیتیشن
- اختلالات عصبی عضلانی - ابتلا به بیماری حاد یا شرایط خاصی که به مراقبت پزشکی نیاز داشته باشد - اختلال روانی شدید و استفاده از داروهای آرامبخش - بروز وقایع استرس زا مثل مرگ فامیل درجه یک، جدایی یا طلاق و درگیری در مسائل حقوقی در شش ماه گذشته اختلال شنوایی و بینایی (کری و لالی) شرکت در پژوهش های دیگر توسط مراقب طی 3 ماه اخیر دریافت هزینه برای مراقبت شرکت در هر گونه کلاس ها یا برنامه های تاثیرگذار بر استرس مثل آرام سازی، یوگا و مدیتیشن
Health conditions studied
#1
C80.0
C80.0
Malignant neoplasm, without specification of site
Malignant neoplasm, without specification of site
cancer
cancer
سرطان
سرطان
Protocol summary
Study aim
Determining the effect of Benson relaxation on the care burden and coping strategies of cancer caregivers
Design
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.
Settings and conduct
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. Demographic characteristics questionnaire, care pressure and coping strategies are completed by both groups before and after four weeks of intervention.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
caregiver burden؛ coping strategies
General information
Reason for update
Correction of the care burden score in the inclusion criteria and recording the date of onset of the sampling
Acronym
IRCT registration information
IRCT registration number:IRCT20210712051849N1
Registration date:2021-07-13, 1400/04/22
Registration timing:prospective
Last update:2021-07-22, 1400/04/31
Update count:2
Registration date
2021-07-13, 1400/04/22
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
2021-07-18, 1400/04/27
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of benson's relaxation on care burden and coping strategies among caregivers of cancer patients
Public title
the effect of benson's relaxation on care burden and coping strategies
Purpose
Supportive
Inclusion/Exclusion criteria
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
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
Age
From 18 years old to 67 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
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
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2021-05-10, 1400/02/20
Ethics committee reference number
IR.MEDSAB.REC.1400.058
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C80.0
ICD-10 code description
Malignant neoplasm, without specification of site
Primary outcomes
1
Description
Care burden of caregivers
Timepoint
Before and four weeks after the intervention
Method of measurement
Novak and Guest Caregiver burden Questionnaire
2
Description
Caregiver coping strategies
Timepoint
Before and four weeks after the intervention
Method of measurement
Endler and Parker Short Form Coping Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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).
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei educational and medical center
Full name of responsible person
Batool Keykhosravi
Street address
Sabzevar, Tohidshahr Boulevard, Vasei Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1313
Email
hamidbarghbani75@gmail.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
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, Vice Chancellor for Research and Technology
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
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, School of Nursing and Midwifery
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
Mojgan Ansari
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, School of Nursing and Midwifery
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8312
Email
mojganansari01@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
hamidbarghbani
Position
Master student of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nuclear Martyrs Boulevard, above the Memorial of the Unknown Martyrs, Campus of the University of Medical Sciences, School of Nursing and Midwifery
City
Sabzevar
Province
Razavi Khorasan
Postal code
9654135121
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