An interventional study of Virtual Reality in Virtual Reality and Intensive Care Unit Acquired Weakness, sponsored by Istinye University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Istinye University · Not applicable, Interventional, and Supportive care
Weakness of respiratory muscles delays weaning from the ventilator, prolongs hospital stay and increases treatment costs. Conventional treatments for respiratory muscles reverse these negative effects. İntensive care services are a set of services that have a very important place in public health care due to the vital support and they provide to all critically ill patients. This care services are constantly improving with the use of technological innovations. With the development of technology, virtual reality application has begun to be used therapeutically in the field of physiotherapy. Virtual reality is the combination of reality and imagination with fictions created using technology. Today, developers can surprisingly create realistic worlds filled with artificial intelligence that behaves believably. Studies have shown positive effects of virtual reality on acute respiratory frequency, pain and fatigue, and in light of this, it was predicted that it would be beneficial to apply to intensive care patients. This study will shed light on the rehabilitation of patients in intensive care and contribute to the literature.
In the study, it was aimed to benefit from the effects of virtual reality application in intensive care patients and have a positive effect on vital signs and respiratory parameters in the early period.
This study will be randomly divided into two groups and it is planned to include 17 partipitants in each group. The first group will receive only conventional treatment, and the second group will receive virtual reality application in addition to conventional treatment. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, shortness of breath and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Nonverbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)-CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used. All evaluations will be made before and after the application and a comparison will be made between the two groups.
1,113 studies on the registry are indexed under Respiratory Aspiration; 219 are open to participants now.
This study's enrollment of 34 is below the median of 42 across 897 interventional studies indexed under Respiratory Aspiration.
Browse Respiratory Aspiration studies →Istinye University is the lead sponsor of 216 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
In the intervention group, virtual reality application will be applied in addition to conventional treatment. In the application, which will be done with VR glasses, a video of walking on Istiklal Street in Istanbul's Beyoğlu district will be watched. To evaluate the effectiveness of the application, vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.
Other: Virtual Reality
Conventional treatment will be applied in the control group. Participants' vital signs, respiratory muscle strength, grip strength, blood gas analysis, dyspnea and fatigue will be evaluated. Additionally, Richmond Agitation Sedation Scale (RASS), Non-Verbal Pain Scale, Glaskow coma scale, Physical Function Test in Intensive Care (PFIT)- CPax (Chelsea Critical Care Physical Assessment Tool) scales will be used.
In the application, which will be done with VR glasses, a video of walking on Istiklal Street in Istanbul's Beyoğlu district will be watched.
Respiratory Muscle Strength (MIP)
Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. MIP is measured at residual volume of lung.
Time frame: 3 days
Respiratory Muscle Strength (MEP)
For respiratory muscle strength, maximal expiratory pressure (MEP) will evaluate using an electronic pressure transducer. MEP is measured from total lung capacity.particularly the diaphragm, while MEPs measure the strength of abdominal and intercostal muscles. For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity.
Time frame: 3 days
Richmond Agitation-Sedation Scale
Interrater reliability. In many intensive care units, the Richmond Agitation-Sedation Scale (RASS) is used to assess the level of sedation. This scale is designed with a three-step procedure that can help give a RASS score range of -5 to +4.The RASS score ranges from -5 (unarousable) to +4 (combative), with 0 meaning alert and calm.
Time frame: 3 days
SOFA (Sequential Organ Failure Assessment)
It evaluates morbidity through six systems (liver, central nervous system, respiratory system, cardiovascular system, renal and coagulation). For each system, points between 1 and 4 are given and the total score is evaluated between 6 and 24. In this score, as the score increases for each system, organ failure is considered to occur.
Time frame: 3 days
Visuel Anaolog Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson\[1\]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For pain intensity according to VAS, "no pain" is usually rated as 0 points and "worst pain imaginable" as 10 points. Ranges for pain intensity; \<3. mild pain, 3-6 moderate pain, \>6 severe pain
Time frame: 3 days
The Glasgow Coma Scale
It is a tool that healthcare providers use to measure decreases in consciousness. The scores from each section of the scale are useful for describing disruptions in nervous system function and also help providers track changes. It's the most widely used tool for measuring comas and decreases in consciousness.The components of the Glasgow Coma Scale include 4 different scores for the eye-opening response, 5 for the verbal response, and 6 for the motor response. The total score has values between 3 and 15. Three is the worst and 15 is the highest.
Time frame: 3 days
APACHE II Score
It is a general measure of disease severity based on current physiologic measurements, age \& previous health conditions. The score can help in the assessment of patients to determine the level \& degree of diagnostic \& therapeutic intervention.APACHE II total score consists of three subheadings: acute physiology score, age and chronic health assessment; the highest value is 71. Mortality is 25% when the total score is 25, and increases to 80% when the total score is 35 and above.
Time frame: 3 days
Chelsea Critical Care Physical Assessment Tool (CPAx)
İt is a test used on male and female patients in the intensive care unit (ICU) to assess physical and respiratory function impairments and morbidity.
Time frame: 3 days
Body temperature
The average normal body temperature is generally accepted as 37°C. Some studies have shown that the "normal" body temperature can have a wide range, from 36.1°C to 37.2°C
Time frame: 3 days
Blood pressure
Normal blood pressure for most adults is defined as a systolic pressure of less than 120 and a diastolic pressure of less than 80. Elevated blood pressure is defined as a systolic pressure between 120 and 129 with a diastolic pressure of less than 80.
Time frame: 3 days
Respiratory rate
The normal range of breathing rate per minute in an average adult, for a person at rest, is 12 - 20 breaths per minute. Any person having a breathing rate under 12 or over 25 is considered to be breathing abnormally.
Time frame: 3 days
Pulse rate
The normal pulse for healthy adults ranges from 60 to 100 beats per minute. The pulse rate may fluctuate and increase with exercise, illness, injury, and emotions.
Time frame: 3 days
The Physical Function in ICU Test
The PFIT-s is a battery outcome measure involving four components: sit to stand assistance, marching on the spot cadence, shoulder flexor and knee extensor strength.
Time frame: 3 days
Hand Strength
Hand muscle strength will be measured with a jamar device.
Time frame: 3 days
Modified Borg Dyspnea Scale
It is a categorical scale with a score from 0 to 10, where 0 represents normal breathing and 10 represents maximum dyspnea.
Time frame: 3 days
Pa02
It is the partial pressure of oxygen in arterial blood. It is used to evaluate oxygenation. Normal values are 80-100 mmHg.
Time frame: 3 days
PaCO2
It is the partial pressure of carbon dioxide in arterial blood. It is an indicator of alveolar ventilation. Normal values are 35-45 mmHg.
Time frame: 3 days
HCO3
It is the serum concentration of bicarbonate ion. It is an important buffer in the blood and is used to evaluate the metabolic component of acid-base balance. Standard bicarbonate: It is the bicarbonate value that should be present in the blood under standard conditions (37°C temperature and 40 mmHg PCO2). Normally it is 22-26 mEq/L.
Time frame: 3 days
Ph
It is used to determine the H+ status of the blood. It shows that the patient is in acidosis or alkalosis, but it is not possible to understand the type by pH. Normal values are 7.35-7.45.
Time frame: 3 days
Confusion Assessment Method for the ICU
The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit. The CAM-ICU assesses for the four features of delirium: Feature 1 is an acute change in mental status or a fluctuating mental status, Feature 2, is inattention, Feature 3, is altered level of consciousness and Feature 4, is disorganized thinking.
Time frame: 3 days
Plan to share: No — Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.