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IRCT20190427043397N1 IRCT 2019-07-26 Tehran University of Medical Sciences effect of respiratory and mobility exercise on pain, anxiety and lung expansion in post surgery patients with cancer Effect of concurrent respiratory workout and mobility exercises on pain, anxiety and lung expansion ability in post-operative lung cancer surgery patients with chest tube 2018-02-20 anticipated 81 Complete https://irct.ir/trial/39155 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A lung cancer. Intervention 1: Intervention group: On the first visit with the patients (before surgery and installation of chest tubes) explanations about interventions and the research was given to them, then the informed consent was signed by the patient and demographic information form was filled out by the researcher. The spirometry results was observed and recorded from patient’s file. Before the operation, when patient was present in the ward, and after filling forms mentioned above, instructions for respiratory workout and mobility exercises including diaphragmatic respiration, pursed lip breathing, chest physiotherapy, physical movements for arm and shoulder of the side that chest tube has been installed (whether its left or right) and using incentive spirometer were given to the patient. These instructions were conducted and controlled by the researcher. After the surgery was finished and patient was transferred to the ward, pain and anxiety were measured using visual analog scale (VAS). A checklist was given to the participant which contained all workouts that he/she was meant to do and asked to fill the checklist each time doing the exercises in order to ensure that they perform exercises correctly. The researcher controlled the checklist in order to make sure that no exercise has been missed. Participants were supposed to do the exercises ten times in one hour according to ability and clinical conditions. Therefore, participants performed each exercise that could do until it reaches ten times in one hour and doesn’t make him/her tired. These activities were performed once each day on certain hours (10 AM to 12 MD) with presence of the researcher until chest tube was removed and VAS marks for pain and anxiety were written down. Intervention 2: Control group: On the first visit with the patients (before surgery and installation of chest tubes) explanations about interventions and the research was given to them, then the informed consent was signed by the patient and demographic information form was filled out by the researcher. The spirometry results was observed and recorded from patient’s file. There were no research related instructions given to the patients of control group. After the surgery was finished and patient was transferred to the ward, pain and anxiety were measured using visual analog scale (VAS). Pain and anxiety were measured daily on certain hours (10 AM to 12 MD) until the tubes were removed. Before the removal of the chest tubes another spirometry test was token from the patients and results were recorded. No - There is not a plan to make this available Justification or reason for not sharing IPD is because of financial problems and costs
public Alireza Arman
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6105 4000 alirezaarman20@gmail.com Tehran University of Medical Sciences scientific Alireza Arman
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
Tehran Iran (Islamic Republic of) 1417653761 +98 21 6105 4000 alirezaarman20@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) having 2 chest tubes installed over 18 years old completely aware of time, place and who he/she is not taking Narcotic drugs at least 4 hours before the interventions no sensory disorders (audio and visual) no substance addiction not taking anti anxiety drugs no history of lung diseases and no history of chest tube installation 18 years no limit Both severe anxiety due to environmental factors not being interested to participate lack of learning ability addiction C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung Prevention Prevention Intervention group: On the first visit with the patients (before surgery and installation of chest tubes) explanations about interventions and the research was given to them, then the informed consent was signed by the patient and demographic information form was filled out by the researcher. The spirometry results was observed and recorded from patient’s file. Before the operation, when patient was present in the ward, and after filling forms mentioned above, instructions for respiratory workout and mobility exercises including diaphragmatic respiration, pursed lip breathing, chest physiotherapy, physical movements for arm and shoulder of the side that chest tube has been installed (whether its left or right) and using incentive spirometer were given to the patient. These instructions were conducted and controlled by the researcher. After the surgery was finished and patient was transferred to the ward, pain and anxiety were measured using visual analog scale (VAS). A checklist was given to the participant which contained all workouts that he/she was meant to do and asked to fill the checklist each time doing the exercises in order to ensure that they perform exercises correctly. The researcher controlled the checklist in order to make sure that no exercise has been missed. Participants were supposed to do the exercises ten times in one hour according to ability and clinical conditions. Therefore, participants performed each exercise that could do until it reaches ten times in one hour and doesn’t make him/her tired. These activities were performed once each day on certain hours (10 AM to 12 MD) with presence of the researcher until chest tube was removed and VAS marks for pain and anxiety were written down. Control group: On the first visit with the patients (before surgery and installation of chest tubes) explanations about interventions and the research was given to them, then the informed consent was signed by the patient and demographic information form was filled out by the researcher. The spirometry results was observed and recorded from patient’s file. There were no research related instructions given to the patients of control group. After the surgery was finished and patient was transferred to the ward, pain and anxiety were measured using visual analog scale (VAS). Pain and anxiety were measured daily on certain hours (10 AM to 12 MD) until the tubes were removed. Before the removal of the chest tubes another spirometry test was token from the patients and results were recorded. Lung expansion mark on spirometry. Timepoint: Before interventing - after interventin (before removing chest tube). Method of measurement: Spirometry. Measured pain using visual analog scale. Timepoint: Everyday until chest tube removal. Method of measurement: Visual Analogue Scale for pain. Measured anxiety using visual analog scale. Timepoint: Everyday until chest tube removal. Method of measurement: Visual Analogue Scale for anxiety. Tehran University of Medical Sciences Approved 2017-10-27 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qods street, Keshavarz boulevard Tehran Tehran Iran (Islamic Republic of)