Determining the effect of Benson relaxation technique on sleep quality in women with breast cancer after mastectomy
Design
Randomized clinical trial has two groups of control and intervention that is performed on 72 patients. For randomization, permutation blocks designed by G-Power software were used.
Settings and conduct
The researcher will start sampling with the approval of the ethics committee of Sabzevar University of Medical Sciences and referring to the officials of Shahid Modarres Hospital in Kashmar. After obtaining informed written consent, the samples will enter the research.
The control group will receive only the usual treatments, but the intervention group will receive the Benson relaxation technique in addition to the usual treatments. After two months, the sleep quality questionnaire will be completed by individuals again and the results will be evaluated between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 30 and 55 years
- full consciousness
- Sleep quality score between 5 to 21
-No other metastatic disease
-No side effects related to chemotherapy
-No specific physical complications associated with surgery
-No severe mental disorders.
-Do not use sedatives.
Criteria for not entering:
or serous discharge at the operation site
-Accompanying metastatic diseases
-Severe mental disorders and the use of sedatives
- Patients who have undergone surgery before the last four months.
-Known neurological andNeuromuscular disorders
-Use other therapies while studying .
Intervention groups
The control group will perform only the usual treatments, but the intervention group will receive Benson's relaxation technique in addition to the usual treatments.
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210108049964N1
Registration date:2021-02-06, 1399/11/18
Registration timing:prospective
Last update:2021-02-06, 1399/11/18
Update count:0
Registration date
2021-02-06, 1399/11/18
Registrant information
Name
Iran Chabok
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5524 7435
Email address
chabokr9@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the Effect of Benson's Relaxation Technique on sleep quality among women with Breast Cancer post mastectomy surgery
Public title
The effect of Benson relaxation technique on sleep quality in patients with mastectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral Mastectomy
Ages 30 to 55
Willingness to participate in the study
Have full consciousness
Sleep quality score between 5 and 21 which is considered as poor sleep quality
No other metastatic disease
The patient has undergone all chemotherapy and radiation therapy after surgery and has been controlled for the relevant complications.
No specific physical complications associated with surgery
No severe mental disorders.
Do not use sedatives
Exclusion criteria:
Occurrence of physical complications related to surgery such as hematoma or serous discharge at the operation site
Accompanying metastatic diseases
Severe mental disorders and the use of sedatives
Patients who underwent surgery before the last four months.
Known neurological disorders such as Parkinson's or multiple sclerosis at the doctor's discretion
Neuromuscular disorders
Use of other therapies while studying
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is based on quadruple blocks that have been designed based on GPower software. Thus, nineteen quadruple blocks are formed and within each block, two people are considered as intervention persons and two people are considered as controls. The main goal of this method is balance. The number of participants in each 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
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Shahrake Tohid
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2020-05-19, 1399/02/30
Ethics committee reference number
IR.MEDSAB.REC.1399.061
Health conditions studied
1
Description of health condition studied
Breast cancer patients undergoing mastectomy
ICD-10 code
N60
ICD-10 code description
Benign mammary dysplasia
Primary outcomes
1
Description
Percentage of people whose sleep quality score is between 5 and 21.
Timepoint
Measurement of sleep quality score at the beginning of the study (before the intervention) and two months after the start of the Benson relaxation technique
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group includes 36 female patients with breast cancer undergoing mastectomy who, in addition to the usual treatments, perform the Benson relaxation technique twice a day, in the morning and in the afternoon, each time for twenty minutes for two months. Performing the correct Benson relaxation technique This technique is performed in the following sequence. The patient is asked to lie down in a comfortable, quiet place and close his eyes, then gently relax his muscles from the bottom of the body upwards (first the leg muscles relax and then this relaxation continues to the face) and At the same time, slowly begin to breathe deeply, inhaling through the nose and exhaling through the mouth. The patient is asked to whisper number one in order to focus more on his breathing as he exhales. The person continues this position for five minutes and during this time all the muscles of the body are at rest The patient is then asked to open his eyes slowly, so that the body is motionless for a few minutes. It is important to note that one should not worry about deep relaxation. Rather, relaxation should be allowed to occur spontaneously, and if some negative thoughts cause a loss of focus for relaxation, people are asked to ignore these thoughts.
Category
Treatment - Other
2
Description
Control group: The control group includes 36 women with breast cancer who have undergone a unilateral mastectomy. The research units in this group perform only the usual pre-study treatments and are controlled for two months in terms of exclusion criteria, etc. They will be followed up and then the sleep quality questionnaire will be completed by them again
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Screening and Diagnosis Center of Shahid Modarres Hospital
Full name of responsible person
Dr Nahid Karimi
Street address
Razi Ave
City
Kashmar
Province
Razavi Khorasan
Postal code
9675143256
Phone
+98 51 5522 7401
Fax
Email
chabokr9@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammadreza Ghasemi
Street address
Shahrak Tohid
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1000
Fax
+98 51 4444 5648
Email
chabokr9@mums.ac.ir
Web page address
Grant name
Sabzevar University of Medical Sciences
Grant code / Reference number
99058
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
Private
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
Raziyeh Chabok
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 25, Behboodi Gharbi Ave
City
Kashmar
Province
Razavi Khorasan
Postal code
9675144635
Phone
+98 51 5524 7435
Fax
+98 51 5522 7413
Email
chabokr9@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mostafa Rad
Position
Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrak Tohid Ave
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1000
Fax
+98 51 4444 5648
Email
mostafarad633@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Raziyeh Chabok
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 25 , Behboodi Gharbi Ave
City
Kashmar
Province
Razavi Khorasan
Postal code
9675144635
Phone
+98 51 5524 7435
Fax
+98 51 5522 7413
Email
chabokr9@mums.ac.ir
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
Due to confidentiality and moral issues and the lack of necessity, there is no plan to publish them.