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IRCT20220829055821N1 IRCT 2022-11-18 Tehran University of Medical Sciences The effect of virtual reality on lung rehabilitation The effect of virtual reality therapy on anxiety, comfort and indicators of pulmonary function after surgery in cancer patients 2022-10-23 anticipated 56 Complete https://irct.ir/trial/65544 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: At first, the numbers 1 to 56 are written on separate papers, and then by lottery, each of the randomly selected samples is assigned a number from 1 to 56, and then the even numbers in a group and number Individuals are placed in another group. Then, similarly, one of the groups is randomly selected as the control group and the other group as the intervention group. N/A cancer. Intervention 1: Intervention group: In addition to the routine pulmonary rehabilitation interventions, the intervention group will also receive virtual reality interventions. The routine pulmonary rehabilitation interventions of the ward are in the form of teaching breathing exercises and chest physiotherapy by the nurse to the patient and his companion, and if necessary, requesting the advice of a physiotherapist and performing breathing exercises in the ward by the physiotherapist. The virtual reality intervention will be done by using SHINECON VR virtual reality glasses with a headset connected to it and showing the scenario of biking in the mountains and canoeing in the lake with visual and auditory stimulation. A mobile phone will be placed inside this device and the scenario playing on the mobile phone will be displayed to the patient in 3D. This device has a sensor to find the direction of head movement and has the ability to create a field of vision of 90 to 100 degrees. The weight of this device is 410 grams, which reaches 576 grams with the phone inside, and it will be placed on the patients' heads. Both scenarios will be reviewed and approved by the surgeon of the research team to ensure suitability for patients and simulating the real environment. On each day of the intervention, only one of the named scenarios is shown to the patients, and the next scenario is shown in the next turn. Patients in the intervention group will receive this intervention in the afternoon and at the patient's preferred time in a sitting position in their room or examination room for 15 to 30 minutes a day and for five days a week in two weeks. During the entire duration of the virtual reality intervention, the members of the research team and the doctor will be present with the patient, so that if the patient does not tolerate the intervention process for any reason, or in case of violent movements and the possibility of damage to the patient and his connections, the intervention will be stopped immediately. be made The data collection tool will be Kolkaba General Comfort Questionnaire (GCQ), Situational Anxiety Questionnaire (STAI) and Demographic Information Questionnaire. In order to check the lung function of patients, the amount of lung function indicators including FEV1 and FVC of patients 48 hours after chest or abdominal surgery will be checked using breathing test. The breath test will be performed at the breath test center of Imam Khomeini Hospital Complex (RA) and the patients will be transferred to this center at the beginning of the study and then 2 weeks after the start of the study and will return to their ward after the breath test. Before starting the interventions for the first time, the mentioned questionnaires will be completed by the patients, or if the patient is unable to read and write, or the patient is unable to speak, the researcher will read the questions in an expressive and understandable voice for the patient and The patient is asked to announce the desired option or point to the desired option with his finger and then the researcher records the answers. Then the usual pulmonary rehabilitation exercises will be performed for both groups and virtual reality exercises for the intervention group. Immediately 2 weeks after the start of the interventions, in order to measure the effectiveness of the pulmonary rehabilitation and the intervention, the FEV1 and FVC levels will be checked again using the breath test from both groups and Kolkaba's general comfort questionnaires. Situational Anxiety Questionnaire (STAI) will be completed again by the patients of both groups in the mentioned ways. Intervention 2: Control group: Control group: The control group will receive routine pulmonary rehabilitation interventions of the ward. The routine pulmonary rehabilitation interventions of the ward are in the form of teaching breathing exercises and chest physiotherapy by the nurse to the patient and his companion, and if necessary, requesting the advice of a physiotherapist and performing breathing exercises in the ward by the physiotherapist. The data collection tool will be Kolkaba General Comfort Questionnaire (GCQ), Situational Anxiety Questionnaire (STAI) and Demographic Information Questionnaire. In order to check the lung function of patients, the amount of lung function indicators including FEV1 and FVC of patients 48 hours after chest or abdominal surgery will be checked using breathing test. The breath test will be performed at the breath test center of Imam Khomeini Hospital Complex (RA) and the patients will be transferred to this center at the beginning of the study and then 2 weeks after the start of the study and will return to their ward after the breath test. Before starting the interventions for the first time, the mentioned questionnaires will be completed by the patients, or if the patient is unable to read and write, or the patient is unable to speak, the researcher will read the questions in an expressive and understandable voice for the patient and The patient is asked to announce the desired option or point to the desired option with his finger and then the researcher records the answers. Then the usual pulmonary rehabilitation exercises will be performed for both groups and virtual reality exercises for the intervention group. Immediately 2 weeks after the start of the interventions, in order to measure the effectiveness of the pulmonary rehabilitation and the intervention, the FEV1 and FVC levels will be checked again using the breath test from both groups and Kolkaba's general comfort questionnaires. Situational Anxiety Questionnaire (STAI) will be completed again by the patients of both groups in the mentioned ways. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After sampling, we should agree with all members of the research team on how to publish the data of the participants, according to the type of data obtained and necessary for publication.
public Nasim Aminaie Chatroodi
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
Tehran Iran (Islamic Republic of) 1419733171 61054317 n-aminaie@sina.tums.ac.ir Tehran University of Medical Sciences scientific Nasim Aminaie Chatroodi
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
Tehran Iran (Islamic Republic of) 1419733171 61054317 n-aminaie@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) A patient diagnosed with cancer and 48 hours have passed since his/her chest or abdominal surgery Having a written order for pulmonary rehabilitation Awareness and awareness of time and place Willingness to participate in the study 18 years 60 years Both Having hearing and vision disorders Having tuberculosis, pneumonia and other inflammatory respiratory diseases Having a history of heart disease Having lung cancer or lung metastasis Having diseases and injuries that disrupt the function of the musculoskeletal system Having a history of epilepsy, dizziness Having cognitive disorders (based on self-report) Rehabilitation Rehabilitation Intervention group: In addition to the routine pulmonary rehabilitation interventions, the intervention group will also receive virtual reality interventions. The routine pulmonary rehabilitation interventions of the ward are in the form of teaching breathing exercises and chest physiotherapy by the nurse to the patient and his companion, and if necessary, requesting the advice of a physiotherapist and performing breathing exercises in the ward by the physiotherapist. The virtual reality intervention will be done by using SHINECON VR virtual reality glasses with a headset connected to it and showing the scenario of biking in the mountains and canoeing in the lake with visual and auditory stimulation. A mobile phone will be placed inside this device and the scenario playing on the mobile phone will be displayed to the patient in 3D. This device has a sensor to find the direction of head movement and has the ability to create a field of vision of 90 to 100 degrees. The weight of this device is 410 grams, which reaches 576 grams with the phone inside, and it will be placed on the patients' heads. Both scenarios will be reviewed and approved by the surgeon of the research team to ensure suitability for patients and simulating the real environment. On each day of the intervention, only one of the named scenarios is shown to the patients, and the next scenario is shown in the next turn. Patients in the intervention group will receive this intervention in the afternoon and at the patient's preferred time in a sitting position in their room or examination room for 15 to 30 minutes a day and for five days a week in two weeks. During the entire duration of the virtual reality intervention, the members of the research team and the doctor will be present with the patient, so that if the patient does not tolerate the intervention process for any reason, or in case of violent movements and the possibility of damage to the patient and his connections, the intervention will be stopped immediately. be made The data collection tool will be Kolkaba General Comfort Questionnaire (GCQ), Situational Anxiety Questionnaire (STAI) and Demographic Information Questionnaire. In order to check the lung function of patients, the amount of lung function indicators including FEV1 and FVC of patients 48 hours after chest or abdominal surgery will be checked using breathing test. The breath test will be performed at the breath test center of Imam Khomeini Hospital Complex (RA) and the patients will be transferred to this center at the beginning of the study and then 2 weeks after the start of the study and will return to their ward after the breath test. Before starting the interventions for the first time, the mentioned questionnaires will be completed by the patients, or if the patient is unable to read and write, or the patient is unable to speak, the researcher will read the questions in an expressive and understandable voice for the patient and The patient is asked to announce the desired option or point to the desired option with his finger and then the researcher records the answers. Then the usual pulmonary rehabilitation exercises will be performed for both groups and virtual reality exercises for the intervention group. Immediately 2 weeks after the start of the interventions, in order to measure the effectiveness of the pulmonary rehabilitation and the intervention, the FEV1 and FVC levels will be checked again using the breath test from both groups and Kolkaba's general comfort questionnaires. Situational Anxiety Questionnaire (STAI) will be completed again by the patients of both groups in the mentioned ways. Control group: Control group: The control group will receive routine pulmonary rehabilitation interventions of the ward. The routine pulmonary rehabilitation interventions of the ward are in the form of teaching breathing exercises and chest physiotherapy by the nurse to the patient and his companion, and if necessary, requesting the advice of a physiotherapist and performing breathing exercises in the ward by the physiotherapist. The data collection tool will be Kolkaba General Comfort Questionnaire (GCQ), Situational Anxiety Questionnaire (STAI) and Demographic Information Questionnaire. In order to check the lung function of patients, the amount of lung function indicators including FEV1 and FVC of patients 48 hours after chest or abdominal surgery will be checked using breathing test. The breath test will be performed at the breath test center of Imam Khomeini Hospital Complex (RA) and the patients will be transferred to this center at the beginning of the study and then 2 weeks after the start of the study and will return to their ward after the breath test. Before starting the interventions for the first time, the mentioned questionnaires will be completed by the patients, or if the patient is unable to read and write, or the patient is unable to speak, the researcher will read the questions in an expressive and understandable voice for the patient and The patient is asked to announce the desired option or point to the desired option with his finger and then the researcher records the answers. Then the usual pulmonary rehabilitation exercises will be performed for both groups and virtual reality exercises for the intervention group. Immediately 2 weeks after the start of the interventions, in order to measure the effectiveness of the pulmonary rehabilitation and the intervention, the FEV1 and FVC levels will be checked again using the breath test from both groups and Kolkaba's general comfort questionnaires. Situational Anxiety Questionnaire (STAI) will be completed again by the patients of both groups in the mentioned ways. FEV۱ - The maximum amount of air that a person can exhale with full force and power in the first second after maximum inhalation. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after the start of the study. Method of measurement: In order to check the lung function of patients, the amount of lung function indicators including FEV1 and FVC of patients 48 hours after chest or abdominal surgery will be checked using breathing test. The breath test will be performed at the breath test center of Imam Khomeini Hospital Complex (RA) and the patients will be transferred to this center at the beginning of the study and then 2 weeks after the start of the study and will return to their ward after the breath test. FVC - The total amount of air exhaled during the FEV test. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after the start of the study. Method of measurement: In order to check the lung function of patients, the amount of lung function indicators including FEV1 and FVC of patients 48 hours after chest or abdominal surgery will be checked using breathing test. The breath test will be performed at the breath test center of Imam Khomeini Hospital Complex (RA) and the patients will be transferred to this center at the beginning of the study and then 2 weeks after the start of the study and will return to their ward after the breath test. Anxiety - A behavioral response such as fear, panic, worry, fatigue, and discomfort occurs when a person feels unsafe following an undefined danger or unknown threat. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after the start of the study. Method of measurement: Situational Anxiety Questionnaire (STAI). Comfort - a multi-dimensional and complex concept and means hope, strength, encouragement and freeing the patient from sadness and problems. In other words, comfort is a person's immediate experience of feeling strong and more than the absence of pain. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after the start of the study. Method of measurement: Kolkaba's General Comfort Questionnaire (GCQ). Tehran University of Medical Sciences Approved 2022-07-11 school of Nursing and Midwifery & school of Rehabilitation - Tehran University of Medical Sciences Tawheed Square, Dr. Mirkhani St. (East Nusrat) Tehran Tehran Iran (Islamic Republic of)