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IRCT20210108049964N1 IRCT 2021-02-06 Sabzevar University of Medical Sciences The effect of Benson relaxation technique on sleep quality in patients with mastectomy Examining the Effect of Benson's Relaxation Technique on sleep quality among women with Breast Cancer post mastectomy surgery 2021-02-19 anticipated 72 Complete https://irct.ir/trial/53899 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Breast cancer patients undergoing mastectomy. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality and moral issues and the lack of necessity, there is no plan to publish them.
public Raziyeh Chabok
No. 25, Behboodi Gharbi Ave
Kashmar Iran (Islamic Republic of) 9675144635 +98 51 5524 7435 chabokr9@mums.ac.ir Sabzevar University of Medical Sciences scientific Dr Mostafa Rad
Shahrak Tohid Ave
Sabzevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1000 mostafarad633@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) 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 30 years 55 years Female 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 N60 Benign mammary dysplasia Treatment - Other Treatment - Other 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. 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 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. Sabzevar University of Medical Sciences Approved 2020-05-19 Ethics Committee of Sabzevar University of Medical Sciences Shahrake Tohid Sabzevar Razavi Khorasan Iran (Islamic Republic of)