Comparing the effect of virtual reality vs autogenic relaxation training on anxiety, quality of sleep and functional independence in patients with traumatic brain injury- A Randomized Clinical Trail

INTRODUCTION

Traumatic brain injury TBI has been defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force. Leading to a range of functional changes that may result in temporary or permanent damage to the brain’s structure and functions. The injury can result in physical, cognitive, emotional, or behavioral impairments, with symptoms varying from temporary confusion to long-term disability or death. More than 90 of the Traumatic Brain Injury TBI burden is shared by low- and middle-income developing countries like India. 1,2

TBI, regardless of severity, has been associated with an increased risk of development of psychiatric disorders. Psychiatric disturbances are reported to occur more frequently among individuals with TBI as compared to healthy individuals regardless of injury severity. Out of which anxiety, depression is common. This impacts the individuals participation in independent functioning such as social, occupational, financial, personal relationships and also affecting the process of rehabilitation. 2,3

Following TBI, sleep disturbance is well recognized and present in around half of patients. Sleep disturbance could be resulting from direct damage to brain areas, or due to secondary effects such as being in the hospital environment, depression, anxiety or pain, and could potentially have an impact on rehabilitation through reduced engagement and impaired learning.1,4

Relaxation exercises have an important role in reducing the negative effects of the emotional problems arising in many neurology-related conditions such as stroke, cerebral palsy, Parkinson disease, brain injury and spinal cord injury. There are many available relaxation techniques such as autogenic relaxation training ART, relaxationbiofeedback, progressive relaxation exercise PRE, and relaxation-hypnosis.

ART is the most commonly used relaxation technique which is found to produce positive effects on various conditions such as anxiety, depression, hypertension, and pain. Autogenic Relaxation Training ART is the most commonly used relaxation technique which an individual carries out themselves by the use of passive concentration and certain combinations of mental and physical stimuli. 5,6

Virtual Reality VR is a rapidly growing technology that refers to immersive and interactive head-mounted display, which offers accessible ways to enable relaxation through visualization, engagement, and immersion with pleasant virtual environments. it is an immersive, interactive experiences to help individuals reduce stress, anxiety, and mental fatigue. Also allow patients active involvement by modifying tasks according to patients needs and

difficulties while providing real-time feedback and thus enhance overall rehabilitation process. 7,8

This randomized clinical trial aims to compare the effects of VR and ART along with conventional physiotherapy exercises on functional independence, anxiety and sleep quality in TBI patients. The findings could provide valuable insights into the integration of these approaches into standard rehabilitation practices for TBI patients.

Need for the study

Traumatic Brain Injury TBI is defined as an injury to the brain caused by an external force, leading to a range of functional changes that may result in temporary or permanent damage to the brain’s structure and functions. 1 Psychiatric disturbances are reported to occur among individuals with TBI regardless of severity of injury. This affects the individuals physical, emotional, social, occupational participation and also affects the finances and relationships. Also limits the patients from understanding their capabilities, their goals, adaptation to new skills and slower the rehabilitation process. 2,9

In the past, rehabilitation exclusively focused on motor rehabilitation however it is important to include the mental and psychological interventions for overall functional development of an individual.

Relaxation exercises have an important role in reducing the negative effects of the emotional problems arising in many neurology-related conditions, there are many relaxation techniques being practiced. 10

In a study conducted by Deepak Thazhakkattu Vasu et.al they found out that the stroke survivors who receive ART in addition to usual physiotherapy reported reduction in their anxiety level, and improvement in functional ability and quality of life. 5

Gillian Murray et.al conducted a study and found that the majority of participants experienced stress reduction and a calming effect as a result of engaging in a VRMM, also reduced cognitive issues in persons with TBI e.g., distractibility and concentration, are more fully engage in, and benefit from the guided mindfulness activities. 11

Future research is warranted to further examine the potential benefits and efficacy of mindfulness utilizing a VR platform in persons with TBI.

Relaxation techniques when added along with conventional physiotherapy could possibly benefit in reducing anxiety, depression, other negative emotions, improve quality of sleep, mood and provide a positive outlook which may consequently facilitate greater functional independence.

While both VR and ART have demonstrated individual effectiveness in reducing anxiety, there is limited research specifically on TBI populations using these interventions on other aspects like functional abilities, quality of sleep etc.

Therefore, this study aims to find out which intervention is most effective in reducing anxiety, improving functional independence, quality of sleep, and thus enhancing overall rehabilitation outcomes in TBI patients.

AIM   To evaluate and compare the effect of Virtual Reality Vs Autogenic Relaxation Training on anxiety, functional independence and quality of sleep in patients with Traumatic Brain Injury.

OBJECTIVE

Primary objective

To compare the effect of Virtual Reality Vs Autogenic Relaxation Training along with conventional physiotherapy exercises on anxiety, functional independence and quality of sleep in patients with mild to moderate traumatic brain injury using Hospital Anxiety and Depression scale HADS, Functional Independence Measure FIM and Pittsburgh Sleep Quality Index PSQI respectively.

Secondary objective

To evaluate the effect of virtual reality along with conventional physiotherapy exercises on anxiety, functional independence and quality of sleep in patients with mild to moderate traumatic brain injury using Hospital Anxiety and Depression scale HADS, Functional Independence Measure FIM and Pittsburgh Sleep Quality Index PSQI respectively.

To evaluate the effect of Autogenic Relaxation Training along with conventional physiotherapy exercises on anxiety, functional independence and quality of sleep in patients with mild to moderate traumatic brain injury using Hospital Anxiety and Depression scale HADS, Functional Independence Measure FIM and Pittsburgh Sleep Quality Index PSQI respectively.

HYPOTHESIS

Null hypothesis: There will be no difference in the effect of Virtual Reality Vs Autogenic Relaxation Training on anxiety, functional independence and quality of sleep in traumatic brain injury patients

Alternative hypothesis: There will be difference in the effect of Virtual Reality Vs Autogenic Relaxation Training on anxiety, functional independence and quality of sleep in traumatic brain injury patients

MATERIALS AND METHODOLOGY

Source of data: Data will be collected from a tertiary care hospital, Belagavi

Study design:    Experimental study

Study type:        A Randomized Clinical Trial

Sampling design:           Probability sampling

Sampling technique: Simple Random Sampling

Sample size n:  22

Duration of study:         12 months

Target population:        Patients diagnosed with mild to moderate TBI

MATERIALS

Informed consent form

Data collection sheet

Hospital Anxiety and Depression Scale

Functional Independence Measure

Pittsburgh sleep quality index PSQI

TOOLS

Virtual reality head mounted display

procus ONE VR headset, Smartphone with 4.7-6.69 display.

OUTCOME MEASURES

Functional Independence Measure

Measures the level of a patient’s disability and indicates how much assistance is required for the individual to carry out activities of daily living.

FIM is composed of 18 items, divided into 2 subscales - motor and cognition.

The total score ranges from 18 to 126, where 18 represents complete dependence, and 126 represents complete independence.

ICC score- 0.85

Hospital Anxiety and Depression Scale

It is 14- items scale that measures anxiety and depression in patients.

Each item is rated on 4 point Likert scale from 0-3. Total scoring is done for both depression and anxiety components.

Interpretation- Scores of 0 to 7  Normal, 8 to 10 - Borderline abnormal, 11 to

21  Abnormal

ICC- 0.80

Pittsburgh sleep quality index PSQI

Pittsburgh Sleep Quality Index PSQI is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval.

There are seven components. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance.

Total score- 0 to 21. Score 5 suggesting significant sleep difficulties. ICC score 0.81

PROCEDURE

Prior to the commencement of the study, Ethical clearance will be obtained from institutional ethical committee.

According to ICMR guidelines the following research will be conducted as it involves human participation.

The study will be registered in Clinical Trials Registry- India CTRI after Ethical Clearance.

Participants from the Tertiary Care Hospital fulfilling the inclusion criteria will be recruited for the study. The participants will be explained about the purpose of the study and written informed assent form primary caregiver in their vernacular language will be obtained for the same.

Diagnosed cases with mild to moderate traumatic brain injury with Rancho Los Amigos level of cognitive function  6.

The subjects will be randomly allocated into Group 1VR and conventional exercise and Group B ATR and conventional exercise using envelope method

Baseline assessment using the outcome measures will be done on the first day before intervention.

Group-A Virtual Reality  Conventional exercises - 5 days week  60 minutes  2 weeks 40 minutes of conventional exercises, 20 minutes of VR

Group-B Autogenic Relaxation Training  Conventional exercises  5 days week  60 minutes  2 weeks 40 minutes of conventional exercises, 20 minutes of ART

The conventional exercises will be according to each patient including ROM exercises, Strengthening and balance exercises.

Assessment will be done using the outcome measures again at the end of 2nd week.

The data collected will be statistically analyzed.