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IRCT20170827035918N2 IRCT 2019-05-12 Tehran University of Medical Sciences the effects of cold therapy and respiratory relaxation technique on pain and anxiety related to chest tube removal in patients who had open heart surgery. the effects of cold therapy and respiratory relaxation technique on pain and anxiety related to chest tube removal in patients who had open heart surgery. 2018-06-22 anticipated 120 Complete https://irct.ir/trial/38577 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: permuted block randomization with a size of four was chosen for this study. firstly, with, drawing lots method, every alphabet of A, B, C, D was assigned to the control group or one of the three intervention groups. Then, two series of 24possible permutations were written separately in different pieces of papers. for example ABCD, ADBC, DCBA,.. written permutations were put in a basket, 30 pieces of papers one by one were drawn out. in this way, the sequence of blocks was determined. after the physician's decisions for removing the chest tubes, the assignments of the patient whose chest tube is going to be removed was determined according to permutation's' order in the block. for example, the first patient's group was determined according to the first permutation in the block, Blinding description: since the researcher prepare the patient before chest tube removal by the physician, the doctor will remain blinded to the grouping. N/A Condition 1: coronary artery diseases. Condition 2: cardiac valve diseases. Condition 3: open heart surgeries. Intervention 1: In the control group(group number 1) chest tube is removed according to the ward regulations without any intervention. Intervention 2: Intervention group: cold application group (intervention group number 1) while the patient in a semi-fowler position with a pillow under his/her head, the dressing of the chest tube is removed and is washed by the researcher with normal saline, then designed the ice bags which are wrapped by gauze are applied around the centre of chest tub until the skin temperature reach to 13 centigrade degrees (about 20 minutes). An infrared thermometer(without any skin contact) was used for all patients. Intervention 3: Intervention group: The respiratory relaxation technique( intervention group 2). Firstly respiratory relaxation technique is instructed to the patient and he/she is asked to do it for 15 minutes. In a quiet environment, the patient, with closed eyes, inhale slowly through the nose with two numbers and exhale through semi-closed lips twice slower. Intervention 4: Intervention group: cold application and respiratory relaxation technique(intervention group number 3 ). 20 minutes before chest tube removal, ice bags are applied for the patient and at the same time, the patient is asked to do respiratory relaxation exercises for 15 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is because the patient's information is confidential, their information will not be published unless the journal needs them for more analysis.
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tehran Iran (Islamic Republic of) 1473138714 +98 21 2236 8763 zahrasajedi75@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) have at least two chest tube. being more than 18 and consciousness BMI under 35 ability to report pain and anxiety have normal vital signs no drug addiction without any mental diseases without any mental , perceptions and communicative problems willingness to enroll in the study 18 years no limit Both Administration of analgesic and sedatives 4 hours before intervention, reactions to Ice unwillingness to continue Other Rehabilitation Rehabilitation Rehabilitation In the control group(group number 1) chest tube is removed according to the ward regulations without any intervention. Intervention group: cold application group (intervention group number 1) while the patient in a semi-fowler position with a pillow under his/her head, the dressing of the chest tube is removed and is washed by the researcher with normal saline, then designed the ice bags which are wrapped by gauze are applied around the centre of chest tub until the skin temperature reach to 13 centigrade degrees (about 20 minutes). An infrared thermometer(without any skin contact) was used for all patients. Intervention group: The respiratory relaxation technique( intervention group 2). Firstly respiratory relaxation technique is instructed to the patient and he/she is asked to do it for 15 minutes. In a quiet environment, the patient, with closed eyes, inhale slowly through the nose with two numbers and exhale through semi-closed lips twice slower. Intervention group: cold application and respiratory relaxation technique(intervention group number 3 ). 20 minutes before chest tube removal, ice bags are applied for the patient and at the same time, the patient is asked to do respiratory relaxation exercises for 15 minutes. Theoretically: Unpleasant sensory and emotional experience associated with tissue damage. Practical: The amount of pain related to chest tube removal the patient reports with the pain numeric rating scale. Timepoint: the pain was assessed in 4 points of time: before the intervention, after intervention before chest tube removal, immediately after chest tube removal, and 15 minutes after chest tube removal. Method of measurement: numeric rating scale (NRS). Anxiety, theoretically: an unpleasant, panic and vague feeling of an unknown source. Practical : The amount of anxiety related to chest tube removal that the patient reports with the numeric rating scale. Timepoint: Anxiety was assessed in 2 points of time: 20 minutes before chest tube removal, immediately before chest tube removal. Method of measurement: numeric rating scale. Tehran University of Medical Sciences Approved 2018-01-07 Ethics committee of research duty of tehran university of Medical Sciences research deputy of Tehran university of medical sciences, Pour Sina St, University St, Enghelab St, Tehran Tehran Iran (Islamic Republic of)