Clinical trial NCT06442254: The Effects of Virtual Reality in Intensive Care Patients
Official title: Examining the Effects of Virtual Reality on Early Vital Variables and Spillovers in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Intensive Care Unit Acquired Weakness
Keywords: virtual reality
intensive care
respiratory muscle strength
respiratory function
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Having multiple organ failure
* Having visual impairment
* Patients who are unconscious

Primary outcomes:
measure: Respiratory Muscle Strength (MIP)
timeFrame: 3 days
measure: Respiratory Muscle Strength (MEP)
timeFrame: 3 days
measure: Richmond Agitation-Sedation Scale
timeFrame: 3 days
measure: SOFA (Sequential Organ Failure Assessment)
timeFrame: 3 days
measure: Visuel Anaolog Scale
timeFrame: 3 days
measure: The Glasgow Coma Scale
timeFrame: 3 days
measure: APACHE II Score
timeFrame: 3 days
measure: Chelsea Critical Care Physical Assessment Tool (CPAx)
timeFrame: 3 days
measure: Body temperature
timeFrame: 3 days
measure: Blood pressure
timeFrame: 3 days
measure: Respiratory rate
timeFrame: 3 days
measure: Pulse rate
timeFrame: 3 days
measure: The Physical Function in ICU Test
timeFrame: 3 days
Secondary outcomes:
measure: Hand Strength
timeFrame: 3 days
measure: Modified Borg Dyspnea Scale
timeFrame: 3 days
measure: Pa02
timeFrame: 3 days
measure: PaCO2
timeFrame: 3 days
measure: HCO3
timeFrame: 3 days
measure: Ph
timeFrame: 3 days
measure: Confusion Assessment Method for the ICU
timeFrame: 3 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstinye Üniversitesi
Study officials:
affiliation: İstinye University
name: Yasemin Çırak, Prof.Dr.
role: STUDY_DIRECTOR
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