Virtual RealityNCT06442254
The Effects of Virtual Reality in Intensive Care Patients
A study testing Virtual Reality in people with Virtual Reality and Intensive Care Unit Acquired Weakness, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Intensive Care Unit Acquired Weakness
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals receiving inpatient treatment in intensive care who volunteer to participate in the research or who are allowed by their first-degree relatives if they are unconscious,
- Being over 18 years of age
- Being eligible to receive physiotherapy and rehabilitation from an intensive care physician
- Are in clinically stable condition
Who cannot join
- Patients with coagulation disorders (PT (Prothrombin Time); INR (International Normalized Ratio) value higher than 1.5 and platelet amount less than 50,000 m³)
- Patients with signs of increased intracranial pressure
- Skin wounds, ulcerations, allergic reactions
- Patients in contact isolation due to infection
- In shock
- Having malignancy
Show all 9Show fewer
- Having multiple organ failure
- Having visual impairment
- Patients who are unconscious
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effects of Virtual Reality on Early Vital Variables and Spillovers in Intensive Care Patients
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.
Read the detailed description
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.
- Being tested
- Virtual Reality
- Keywords
- virtual reality, intensive care, respiratory muscle strength, respiratory function
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | 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. Receives: Other: Virtual Reality |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 days
Secondary outcomes (7)
Hand Strength
Hand muscle strength will be measured with a jamar device.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start8 Jun 2024
- Primary completion10 Aug 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
- Investigators
- Yasemin Çırak, Prof.Dr., Study director, İstinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442254
- Sponsor's protocol ID
- 23-152
- Status last verified
- Oct 2024
- First submitted
- 1 May 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9.
PubMed 27030815Makhabah DN, Martino F, Ambrosino N. Peri-operative physiotherapy. Multidiscip Respir Med. 2013 Jan 23;8(1):4. doi: 10.1186/2049-6958-8-4.
PubMed 23343253Yousefnia-Darzi F, Hasavari F, Khaleghdoost T, Kazemnezhad-Leyli E, Khalili M. Effects of thoracic squeezing on airway secretion removal in mechanically ventilated patients. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):337-42. doi: 10.4103/1735-9066.180374.
PubMed 27186214Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.
PubMed 25029020Ratnovsky A, Elad D, Halpern P. Mechanics of respiratory muscles. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):82-9. doi: 10.1016/j.resp.2008.04.019. Epub 2008 May 15.
PubMed 18583200Castro-Avila AC, Seron P, Fan E, Gaete M, Mickan S. Effect of Early Rehabilitation during Intensive Care Unit Stay on Functional Status: Systematic Review and Meta-Analysis. PLoS One. 2015 Jul 1;10(7):e0130722. doi: 10.1371/journal.pone.0130722. eCollection 2015.
PubMed 26132803Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
PubMed 11730446Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.
PubMed 23219649Alves da Cruz MM, Ricci-Vitor AL, Bonini Borges GL, Fernanda da Silva P, Ribeiro F, Marques Vanderlei LC. Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial. Arch Phys Med Rehabil. 2020 Apr;101(4):642-649. doi: 10.1016/j.apmr.2019.12.006. Epub 2020 Jan 8.
PubMed 31926142Taslimipour S, Rojhani-Shirazi Z, Hemmati L, Rezaei I. Effects of a Virtual Reality Dance Training Program on Kyphosis Angle and Respiratory Parameters in Young Women With Postural Hyperkyphosis: A Randomized Controlled Clinical Trial. J Sport Rehabil. 2020 May 13;30(2):293-299. doi: 10.1123/jsr.2019-0303.
PubMed 32404535Pazzaglia C, Imbimbo I, Tranchita E, Minganti C, Ricciardi D, Lo Monaco R, Parisi A, Padua L. Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial. Physiotherapy. 2020 Mar;106:36-42. doi: 10.1016/j.physio.2019.12.007. Epub 2019 Dec 23.
PubMed 32026844Rodrigues IM, Lima AG, Santos AED, Santos ACA, Nascimento LSD, Serra MVCL, Pereira TJS, Barbosa FDS, Seixas VM, Monte-Silva K, Scipioni KRDDS, Cruz DMCD, Piscitelli D, Goffredo M, Gois-Junior MB, Zanona AF. A Single Session of Virtual Reality Improved Tiredness, Shortness of Breath, Anxiety, Depression and Well-Being in Hospitalized Individuals with COVID-19: A Randomized Clinical Trial. J Pers Med. 2022 May 19;12(5):829. doi: 10.3390/jpm12050829.
PubMed 35629250Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
PubMed 24436844Trampisch US, Franke J, Jedamzik N, Hinrichs T, Platen P. Optimal Jamar dynamometer handle position to assess maximal isometric hand grip strength in epidemiological studies. J Hand Surg Am. 2012 Nov;37(11):2368-73. doi: 10.1016/j.jhsa.2012.08.014.
PubMed 23101534Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
PubMed 12421743
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Virtual Reality on Early Vital Variables and Spillovers in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06442254
- Acronym / sponsor ID
- 23-152
- Keywords
- virtual reality, intensive care, respiratory muscle strength, respiratory function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual RealityIn 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals receiving inpatient treatment in intensive care who volunteer to participate in the research or who are allowed by their first-degree relatives if they are unconscious,
- Being over 18 years of age
- Being eligible to receive physiotherapy and rehabilitation from an intensive care physician
- Are in clinically stable condition
Key exclusion criteria (9 listed)
- Patients with coagulation disorders (PT (Prothrombin Time); INR (International Normalized Ratio) value higher than 1.5 and platelet amount less than 50,000 m³)
- Patients with signs of increased intracranial pressure
- Skin wounds, ulcerations, allergic reactions
- Patients in contact isolation due to infection
- In shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityIn the application, which will be done with VR glasses, a video of walking on Istiklal Street in Istanbul's Beyoğlu district will be watched. | Other | Virtual Reality Group |
Primary outcome
Respiratory Muscle Strength (MIP)
Time frame: 3 days
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.
Respiratory Muscle Strength (MEP)
Time frame: 3 days
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.
Richmond Agitation-Sedation Scale
Time frame: 3 days
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.
SOFA (Sequential Organ Failure Assessment)
Time frame: 3 days
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.
Visuel Anaolog Scale
Time frame: 3 days
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
The Glasgow Coma Scale
Time frame: 3 days
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.
APACHE II Score
Time frame: 3 days
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.
Chelsea Critical Care Physical Assessment Tool (CPAx)
Time frame: 3 days
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.
Body temperature
Time frame: 3 days
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
Blood pressure
Time frame: 3 days
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.
Respiratory rate
Time frame: 3 days
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.
Pulse rate
Time frame: 3 days
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.
The Physical Function in ICU Test
Time frame: 3 days
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.
7 secondary outcomes
Hand Strength
Time frame: 3 days
Modified Borg Dyspnea Scale
Time frame: 3 days
Pa02
Time frame: 3 days
PaCO2
Time frame: 3 days
HCO3
Time frame: 3 days
Ph
Time frame: 3 days
Confusion Assessment Method for the ICU
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Results publication: PubMed 27030815Berger D, Bloechlinger S, von Haehling S, Doehner W, Takala J, Z'Graggen WJ, Schefold JC. Dysfunction of respiratory muscles in critically ill patients on the intensive care unit. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):403-12. doi: 10.1002/jcsm.12108. Epub 2016 Mar 9.
- Results publication: PubMed 23343253Makhabah DN, Martino F, Ambrosino N. Peri-operative physiotherapy. Multidiscip Respir Med. 2013 Jan 23;8(1):4. doi: 10.1186/2049-6958-8-4.
- Results publication: PubMed 27186214Yousefnia-Darzi F, Hasavari F, Khaleghdoost T, Kazemnezhad-Leyli E, Khalili M. Effects of thoracic squeezing on airway secretion removal in mechanically ventilated patients. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):337-42. doi: 10.4103/1735-9066.180374.
- Results publication: PubMed 25029020Kalanuria AA, Ziai W, Mirski M. Ventilator-associated pneumonia in the ICU. Crit Care. 2014 Mar 18;18(2):208. doi: 10.1186/cc13775. No abstract available.
- Results publication: PubMed 18583200Ratnovsky A, Elad D, Halpern P. Mechanics of respiratory muscles. Respir Physiol Neurobiol. 2008 Nov 30;163(1-3):82-9. doi: 10.1016/j.resp.2008.04.019. Epub 2008 May 15.
- Results publication: PubMed 26132803Castro-Avila AC, Seron P, Fan E, Gaete M, Mickan S. Effect of Early Rehabilitation during Intensive Care Unit Stay on Functional Status: Systematic Review and Meta-Analysis. PLoS One. 2015 Jul 1;10(7):e0130722. doi: 10.1371/journal.pone.0130722. eCollection 2015.
- Results publication: PubMed 11730446Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
- Results publication: PubMed 23219649Corner EJ, Wood H, Englebretsen C, Thomas A, Grant RL, Nikoletou D, Soni N. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013 Mar;99(1):33-41. doi: 10.1016/j.physio.2012.01.003. Epub 2012 Mar 30.
- Results publication: PubMed 31926142Alves da Cruz MM, Ricci-Vitor AL, Bonini Borges GL, Fernanda da Silva P, Ribeiro F, Marques Vanderlei LC. Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial. Arch Phys Med Rehabil. 2020 Apr;101(4):642-649. doi: 10.1016/j.apmr.2019.12.006. Epub 2020 Jan 8.
- Results publication: PubMed 32404535Taslimipour S, Rojhani-Shirazi Z, Hemmati L, Rezaei I. Effects of a Virtual Reality Dance Training Program on Kyphosis Angle and Respiratory Parameters in Young Women With Postural Hyperkyphosis: A Randomized Controlled Clinical Trial. J Sport Rehabil. 2020 May 13;30(2):293-299. doi: 10.1123/jsr.2019-0303.
- Results publication: PubMed 32026844Pazzaglia C, Imbimbo I, Tranchita E, Minganti C, Ricciardi D, Lo Monaco R, Parisi A, Padua L. Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial. Physiotherapy. 2020 Mar;106:36-42. doi: 10.1016/j.physio.2019.12.007. Epub 2019 Dec 23.
- Results publication: PubMed 35629250Rodrigues IM, Lima AG, Santos AED, Santos ACA, Nascimento LSD, Serra MVCL, Pereira TJS, Barbosa FDS, Seixas VM, Monte-Silva K, Scipioni KRDDS, Cruz DMCD, Piscitelli D, Goffredo M, Gois-Junior MB, Zanona AF. A Single Session of Virtual Reality Improved Tiredness, Shortness of Breath, Anxiety, Depression and Well-Being in Hospitalized Individuals with COVID-19: A Randomized Clinical Trial. J Pers Med. 2022 May 19;12(5):829. doi: 10.3390/jpm12050829.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Çırak, Prof.Dr. study director
İstinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Virtual Reality and Intensive Care Unit Acquired Weakness, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Muscle Strength (MIP) (time frame: 3 days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442254, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.