To determine the effect of Benson's relaxation technique on the Death Anxiety and hope in women with breast cancer
Design
Firstly, a convenience sample of 100 women with breast cancer will be selected.from Velayat Hospital. Then the subject were assigned to the control and intervention groups (each group Contains 50) .The researcher will train the relaxation techniques. Subjects will be asked to perform the relaxation for 15 to 20 minutes 2 to 3 times a day . A self-report questionnaire has been developed and provided for the subjects to record their daily performance.
Settings and conduct
The researcher will train the relaxation techniques. Subjects will be asked to perform the relaxation for 15 to 20 minutes 2 to 3 times a day . A self-report questionnaire has been developed and provided for the subjects to record their daily performance.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Breast Cancer,Ability to communicate in Persian,History of taking anti-anxiety medications,History of participation in training courses (before and during the research)؛Exclusion Criteria: Unwillingness to continue and lack of cooperation at any time of study,History of neurologic and musculoskeletal disorders, auditory problems, and drug abuse
Intervention groups
Intervention group:
In this study, Benson's relaxation technique was used. The researcher will train the relaxation technique individually in velayat Hospital. The subjects will be asked to do the relaxation for 15 to 20 minutes 2 to 3 times per day. During the period of cancer treatment they will do Benson’s relaxation technique for 20 minutes twice a day at 9 am and 5 pm, in a 3-month period and follow up monthly. As individual characteristics affect learning of relaxation technique, and some subjects might : forget the technique, a self-report questionnaire has been developed and provided to the subjects to record their daily performance. Also, contact details will be provided to the subjects in order to contact the researcher in case of any problem or question.
Control group: No relaxation technique is taught to the control group.
Main outcome variables
Death Anxiety and hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170610034435N8
Registration date:2018-03-30, 1397/01/10
Registration timing:retrospective
Last update:2018-03-30, 1397/01/10
Update count:0
Registration date
2018-03-30, 1397/01/10
Registrant information
Name
Samira Moradipour
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 0775
Email address
s.moradipoor@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-10-22, 1396/07/30
Trial completion date
empty
Scientific title
The effect of Benson’ relaxation technique on the death anxiety and hope in women with breast cancer
Public title
"Effect of relaxation on Death Anxiety and Hope"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Breast Cancer
Ability to communicate in Persian
History of taking anti-anxiety medications
History of participation in training courses (before and during the research)
Exclusion criteria:
History of neurologic and musculoskeletal disorders, auditory problems, and drug abuse
"Unwillingness to continue and lack of cooperation at any time of study"
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
91
Randomization (investigator's opinion)
Randomized
Randomization description
This clinical trial followed by a pretest-posttest design with a control group. Initially, 100 patients referred to Velayat Education and Treatment Center in Qazvin were selected based on inclusion criteria using a convenience sampling method and, then, were assigned into two groups, i.e. a control group and an experimental group, using a foursome block random allocation method. Therefore, by 25 choices of the 6 available foursome blocks, the sample size of 100 was reached. Finally, 50 people in the control group and 50 people in the experimental group can be reached in this way.
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
Ethics committee of Qazvin، University of Medical Sciences
Street address
Shahid Bahonar Street، Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.QUMS.REC.1396.25
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
death anxiety
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Templar death anxiety inventory
Secondary outcomes
1
Description
Hope
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Herth hope questionnaire
2
Description
death anxiety
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Templer death anxiety questionnaire
Intervention groups
1
Description
Intervention group:In this study, Benson's relaxation technique was used. The researcher will train the relaxation technique individually in one or two sessions in a private room of velayat Hospital. The training will be repeated if needed. Then, the subjects will be asked to demonstrate this technique to the researcher in order to resolve any problem. The subjects will be asked to do the relaxation for 15 to 20 minutes 2 to 3 times per day. During the period of cancer treatment they will do Benson’s relaxation technique for 20 minutes twice a day at 9 am and 5 pm, in a 3-month period and follow up monthly. As individual characteristics affect learning of relaxation technique, and some subjects might : forget the technique, a self-report questionnaire has been developed and provided to the subjects to record their daily performance. Also, contact details will be provided to the subjects in order to contact the researcher in case of any problem or question.
Category
Behavior
2
Description
Control group: No relaxation technique is taught to the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin velayat hospital
Full name of responsible person
Samira moradipor
Street address
Elahiyeh، Minodar
City
Qazvin
Province
Qazvin
Postal code
4193713191
Phone
+98 28 3379 0620
Email
moradipour5830@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Qazvin University of Medical Science
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
moradipour5830@gmail.com
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
2
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samira moradipour
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Street
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
moradipour5830@gmail.com
Grant name
- NO
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin university of medical sciences
Full name of responsible person
Samira Moradipour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street، kosar hospital
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
Email
moradipour5830@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samira Moradipour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street، kosar hospital
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6382
Fax
Email
moradipour5830@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Samira Moradipour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Street، Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Fax
Email
moradipour5830@gmail.com
Web page address
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