AnxietyNCT05985096
The Effects of Virtual Reality Education on Balance, Depression, Anxiety and Stress Parameters
A study testing Virtual reality group in people with Anxiety and Depression, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
If we examine the demographic data of the 2021 reports of the Turkish Statistical Institute (TUIK), we can see that the young population between the ages of 15 and 24 is 12,971,289 people, which is 15.3% of the total population. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Stress
- What is being tested?
- Virtual reality group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 5 Jun 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering
- Being between 18-25 years old
Who cannot join
- Having a musculoskeletal disease
- Having a systemic (cardiovascular, neurological) disease
- Not attending the training sessions more than once
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ordu University Faculty of Medicine Department of Anatomy
Ordu, Black Sea, 52000
Muhammet Değermenci, PhD, mdegermenci@yahoo.com.tr
About this study
Official title: The Effects of Virtual Reality Education on Balance, Depression, Anxiety and Stress Parameters in Healthy Young Individuals
If we examine the demographic data of the 2021 reports of the Turkish Statistical Institute (TUIK), we can see that the young population between the ages of 15 and 24 is 12,971,289 people, which is 15.3% of the total population. Considering the proportion of young population in our country, the evaluation of physical activity level has an important place, while the proportion of female university students who achieved sufficient physical activity level according to the scoring of the International Physical Activity Questionnaire (UFAA) was 8.5%, while the proportion of male students was 28.1% in previous studies (Arslan 2015). ).
We know from previous studies that achieving an adequate level of physical activity directly reduces the body mass index and indirectly reduces the cardiovascular risk associated with obesity (Swift 2018). Exercise reduces depression levels and the effects of depression. Although the neural mechanisms are not very clear, there are some predictions for physical exercise to reduce the level of depression (Gujral 2017). The hippocampus is an important cognitive and sensory centre, and it has been reported that hippocampal volume decreases by 5% in depressed individuals (Cole 2011). Hippocampal volume has been reported to increase rapidly with exercise (Bugg 2012).
Read more
The brain region most affected in major depressive disorder is the prefrontal cortex. After the prefrontal cortex is affected, symptoms such as negative affect and learned helplessness appear (Pizagalli 2021). Experimental studies in mice have shown that treadmill training creates new synaptic pathways in the prefrontal cortex and hippocampus (Mu 2022).
Another brain region affected by depression is the corpus striatum. Loss of corpus striatum volume is observed in patients with major depression (Zhang 2020). The volume of the corpus striatum modulates when physical exercise reaches a sufficient level. (Rotttensteiner 2015).
Adequate levels of physical activity not only reduce depression, but also prevent neural dysfunction that can occur as a result of depression. However, young people do not get enough exercise. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation.
The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people.
Read the detailed description
Our work will last 6 weeks and is planned as exercise for 1 hour a day, 2 days a week.
Group 1: The control group will do individual exercise. The monitoring of the physical exercises will be done with video recordings.
Physical exercises Stick exercises: Shoulder stick (wand) exercises aim to perform shoulder range of motion exercises by supporting the sore arm with a solid arm. Use the stick to make forward, side, backward, outward and inward movements as shown in the picture. Count to 5 at the end of each movement and return to the beginning (Puendgsuwan 2008).
Codman exercises: Step forward with one foot and lean forward on a stable surface such as a table. Release your arm using the weight: move it back and forth like a pendulum. c) Circle clockwise and counterclockwise (Cunningham 2020).
Squat exercises: With feet open at shoulder height, the person's back is against the wall and positioned 10 cm in front of the wall. The rolling pin on the shoulder is grasped with the hands. The person faces forward. The movement is performed by bending the hip and knee joints without disturbing the straightness of the back and without touching the wall. Then return to starting position, keeping the spine straight and extending the hip and knee joints. Perform 3 sets of 10 repetitions (Kubo 2019).
Tandem walking exercise: A straight line is drawn on the floor. From the person, 10 steps are taken to follow this straight line with the heel of the front foot to the tip of the back foot. 3 sets of eyes open and 3 sets of eyes closed (Cruz 2021).
Group 2: Virtual reality group. People in this group will be expected to meet their physical activity levels with Racket, Climb, Acron, Skiing, Cycling games using the Oculus Quest 2 VR goggles platform.
Virtual reality games Racket: Nx is a new type of game in VR that pushes the boundaries of what you can do with a racket and a ball. The game takes place inside a giant glass dome, the walls of which are lit up with targets that you have to destroy with the cannon. But this is no ordinary ball. If you hit it hard, it will crash into a wall, roll over, and bulldozers will crush everything in its path. Use the racket's hammer beam to retreat or aim the next hit exactly where you want it. Targets appear in waves and the aim is to destroy them all before you run out of energy. But targets aren't the only thing in the arena. That's why you need to hit quickly and accurately. But in this game, the aim is to teach you how to control the ball perfectly. It is an alternative to coordination exercises.
Climbing: The aim of this game is to simulate climbing. It can be used as an alternative to strengthening the upper limbs. From exploring mountain environments to scaling urban environments, the game is also designed to have the dual effect of feeling the excitement of climbing without ropes and experiencing the landscapes as you climb to new heights.
Acron: In this game, you take on the role of a large, ancient tree that is the sole guardian of golden acorns. In this simulation, he uses an arsenal of unique abilities across seven different maps to try and prevent golden acorns from being stolen. We plan to use this simulation as an alternative to lower extremity strengthening exercises.
Skiing: Start with your feet shoulder-width apart, arms at eye level and bent 90°. Then swing your arms down and back while squatting. Don't squat too deep and squeeze your core. Finally, swing your arms back to their original position while standing. Continue to squat and swing your arms vigorously. The aim of this simulation is to provide an alternative to squatting and wand exercises.
Cycling: How to play: Stand upright, keeping your core strong and engaged, and start 'cycling' with your arms. There are also two ways to do circular arm movements: with the arms at your sides, mostly as regular arm cycling moves, which will focus on the shoulders, chest and triceps muscles, or as boxing speedbag moves, with the forearms side by side at face level, which will focus on the forearms, triceps muscles and shoulder blades. The aim of this simulation is to provide an alternative to balance, stick and Codman exercises.
Questionnaires and tests to be used for evaluation Depression-Anxiety Stress Scale 21 (DASS 21): It is estimated that by 2020, depression, stress and anxiety-related disorders will be the second most common disease in the world. The prevalence of these disorders can also have a significant negative impact on countries' health expenditure, social harmony, business life and individuals. This scale will be used to measure the depression burden of students.
Motivation scale for participation in physical activity: This 16-question questionnaire assesses an individual's motivation to participate in physical activity. Questions 1-6 of the survey form the individual causes, 7-12 form the environmental causes and questions 13-16 form the dimension of irrationality. Questions 3,9,13,14,15,16 are reverse coded.
Repetitive joint position sense test: The test is scored during arm elevation positions that include 90° shoulder flexion and 90° shoulder abduction movements. For the shoulder flexion assessment, the individual is asked to stand facing the millimetre paper taped to the wall. The laser cursor is positioned 5 cm above the elbow joint so that wrist and elbow movements do not affect the measurements. The subject is asked to flex the shoulder joint to 90°. This shoulder movement is measured by the physiotherapist using a goniometer and the person is asked to maintain this position for 10 seconds with eyes open. The projection of the laser cursor is marked on millimetre paper. The 90° position is repeated 3 times with the eyes open and the person is asked to memorise this position. It is then returned to the starting position and the subject's eyes are closed. He is asked to repeat the same movement 3 times and the projection of the laser cursor is marked. For the abduction movement, the subject is asked to turn sideways towards the wall, with the head turned towards the wall, bringing the arm to 90° abduction and the angle is measured with a goniometer. The projections of the laser cursor are also marked. The starting point is assumed to be 0 and the projections of the points on the x and y axes are measured during the angle repetition. The deviation is calculated using the formula c=√x2+y2 (Düzgün 2011).
Star Balance Test: The Star Balance Test, originally called the Star Excursion Balance Test, is a reliable tool for measuring dynamic balance. Designed for the assessment of lower extremity injuries and disorders, it is also widely used to assess dynamic balance in sport. In addition, the Star Excursion Balance Test has been shown to have a high coefficient of internal reliability, but its coefficients of validity have not been investigated. The test is based on the ability to reach the farthest possible distance on the supporting leg with the free leg in 8 different directions and is a very high quality measure of dynamic balance performance in sport (Gribble 2013). Before starting the test, a dry and quiet environment that is not affected by changing weather conditions should be selected for the test. This is the most basic requirement for a valid and reliable test between repeated measurements.
Required Equipment
- A minimum of 2×2 meters of flat, dry and suitable Ground
- Test manager and scoring chart
- Flat adhesive tape (minimum 8 meters)
- Ruler or Metre Application: 4 strips cut to 2 metres are placed on the floor at an angle of 45 degrees. The subject should be barefoot if possible. Shoes affect the reliability of the test in repeated tests. The athlete waits in the centre of the star shape (the point where the lines intersect). If the right foot is chosen as the reach foot, the test direction is clockwise. For the left foot, the direction is counter-clockwise. The hands should be at the waist during the test and the position of the hands should not change during the test. If this is not the case, the athlete places the hands on the waist, repeats whichever line is left, and continues the test. The athlete reaches out as far as he can with his foot and lightly touches the strip with the tip of his toe. He then returns to the starting position (hands around his waist, feet in the air, on one leg). Then the other line is walked and a total of 8 lines are completed in this way. Each time, the examiner makes a mark with a pencil to measure the maximum point that the subject can touch at a later time. After the whole process has been repeated 3 times with the right foot, the left foot is switched and the process is repeated 3 times (Shaffer 2013). At the end of the test, the participant records the distances reached in the Cartex.
Nelson Hand Reaction Test: The Nelson hand reaction test can be measured using the ruler method. The subject is seated in a chair with the forearm and hand resting relaxed on the table. The tips of the thumb and forefinger are placed 8-10 cm from the table so that they are approximately parallel on the outside. The tips of the thumb and index finger should be horizontal to each other. The examiner holds the tip of the ruler between the thumb and index finger of the subject. The subject is instructed to look directly at the concentration zone (the black area between lines 0.120 and 0.30) and to catch the ruler when it is released. There are 20 trials, each starting after the 'ready' command. The result is read from the line at the top of the subject's thumb after the subject has caught the ruler. The lowest 5 and the highest 5 trials are discarded and the average of the remaining 10 trials is recorded as the result. The digits on the time scale represent thousandths of a second. The results are recorded as 5/1000 seconds (Musabaşoğlu 2008).
Mini Best Test: This test is used to evaluate the balance. The Mini Best (DDS) test has 14 parameters. Anticipatory postural control (standing up from sitting; toes up; standing on one leg), reactive postural control (compensatory corrective stepping forward; compensatory corrective stepping backward; compensatory corrective stepping sideways), sensory orientation (standing position (feet together); eyes open, hard surface; standing position (feet together): eyes closed, spongy surface; tilt - eyes closed), dynamic gait (change of walking speed; walking with horizontal head movements; turning while walking; stepping over an obstacle; double The task is evaluated with timed get up \& walk tests [ 3 metres walking).
Scoring: The test consists of 14 items, each scored from 0 to 2 out of a maximum of 28. "0' indicates the lowest level of function and '2' indicates the highest level of function. If the person requires the use of an assistive device for any item, that item is scored one level lower. If the person requires physical assistance to perform the item, score that item as "0". For item 3 (standing on one leg) and item 6 (compensatory stepping - lateral), record the score of only one side (low score). For item 3 (standing on one leg) take the best time from 2 attempts (each side separately). For item 14 (time to stand up and walk with double duty), the score should be reduced by one level if the person's gait slows by more than 10% between double duty and non-double duty SCI.
Measurement Evaluation and Statistical Analysis
- Sample size: Gpower 3.1. determined by power analysis using the programme. In the analysis (α=0.05, power (1-β) = 0.80, effect size= 0.8, and at least n=26 people should be included in the groups. It was set at n=30 in case of dropout.
- Number and names of groups in the study: Group 1: Control group Group 2: Virtual reality grou
- Properties to be measured: Depression, anxiety, stress parameters Balance Repetitive joint position sense Participation in physical activity Motivation Hand reaction
- Statistical analysis: The data in the study are analysed using 5 parameters (skewness-curvature, Std/Mean, Q-Q plots, histogram and Shapiro-Wilk test). The parameters with a score higher than 3 and a sufficient number of data are considered to be normally distributed and are presented as Mean±Standard Deviation (MEAN±STD).The Independent Samples T-test is used to compare two independent groups and the Related Samples T-test is used to compare dependent groups. Pearson correlation is used for correlation analysis of parametric data. Parameters with a score of 3 or less in the normal distribution analysis are considered non-parametric, and the Mann-Whitney U test is used for comparisons between two independent groups, the Wilcoxon test is used for comparisons between dependent groups, and Spearman Rho's correlation analysis is used for correlation analysis. In the study, α=0.05 and p<α are considered significant. The IBM SPSS 28.00 package programme will be used for statistical analysis.
- Conditions
- Anxiety, Depression, Stress, Balanced
- Being tested
- Virtual reality group
- Keywords
- Depression, Stress, Anxiety, Virtual reality glasses
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality groupDiagnostic test
Participants in this group will be expected to meet their physical activity levels using the Oculus Quest 2 VR Goggles platform with Racket, Climb, Acron, Skiing, Cycling games.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Adequate physical activity not only reduces depression, but also prevents the neural dysfunction that can occur as a result of depression. However, the level of physical activity among young people is not sufficient. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation.
The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people. Receives: Diagnostic Test: Virtual reality group |
| Control Group | No intervention | The control group will perform individual exercise. The physical activity will be monitored with video recordings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in depression, anxiety stress parameters
The specified parameters are calculated using the DASS 21 scale before and after the intervention.
Measured: 6 weeks
Secondary outcomes (1)
Increased hand reaction
Before and after the intervention, specified parameters are measured using the Nelson Hand Reaction Test.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Sep 2023 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion5 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HALİL YILMAZ, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985096
- Sponsor's protocol ID
- A-2325
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bugg JM, Shah K, Villareal DT, Head D. Cognitive and neural correlates of aerobic fitness in obese older adults. Exp Aging Res. 2012;38(2):131-45. doi: 10.1080/0361073X.2012.659995.
PubMed 22404537Cole J, Costafreda SG, McGuffin P, Fu CH. Hippocampal atrophy in first episode depression: a meta-analysis of magnetic resonance imaging studies. J Affect Disord. 2011 Nov;134(1-3):483-7. doi: 10.1016/j.jad.2011.05.057. Epub 2011 Jul 13.
PubMed 21745692Perez-de la Cruz S. Comparison between Three Therapeutic Options for the Treatment of Balance and Gait in Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 7;18(2):426. doi: 10.3390/ijerph18020426.
PubMed 33430476Cunningham G, Charbonnier C, Ladermann A, Chague S, Sonnabend DH. Shoulder Motion Analysis During Codman Pendulum Exercises. Arthrosc Sports Med Rehabil. 2020 Jun 26;2(4):e333-e339. doi: 10.1016/j.asmr.2020.04.013. eCollection 2020 Aug.
PubMed 32875297Gribble PA, Kelly SE, Refshauge KM, Hiller CE. Interrater reliability of the star excursion balance test. J Athl Train. 2013 Sep-Oct;48(5):621-6. doi: 10.4085/1062-6050-48.3.03. Epub 2013 Mar 19.
PubMed 24067151Gujral S, Aizenstein H, Reynolds CF 3rd, Butters MA, Erickson KI. Exercise effects on depression: Possible neural mechanisms. Gen Hosp Psychiatry. 2017 Nov;49:2-10. doi: 10.1016/j.genhosppsych.2017.04.012.
PubMed 29122145Kubo K, Ikebukuro T, Yata H. Effects of squat training with different depths on lower limb muscle volumes. Eur J Appl Physiol. 2019 Sep;119(9):1933-1942. doi: 10.1007/s00421-019-04181-y. Epub 2019 Jun 22.
PubMed 31230110Mu L, Cai J, Gu B, Yu L, Li C, Liu QS, Zhao L. Treadmill Exercise Prevents Decline in Spatial Learning and Memory in 3xTg-AD Mice through Enhancement of Structural Synaptic Plasticity of the Hippocampus and Prefrontal Cortex. Cells. 2022 Jan 12;11(2):244. doi: 10.3390/cells11020244.
PubMed 35053360Pizzagalli DA, Roberts AC. Prefrontal cortex and depression. Neuropsychopharmacology. 2022 Jan;47(1):225-246. doi: 10.1038/s41386-021-01101-7. Epub 2021 Aug 2.
PubMed 34341498Rottensteiner M, Leskinen T, Niskanen E, Aaltonen S, Mutikainen S, Wikgren J, Heikkila K, Kovanen V, Kainulainen H, Kaprio J, Tarkka IM, Kujala UM. Physical activity, fitness, glucose homeostasis, and brain morphology in twins. Med Sci Sports Exerc. 2015 Mar;47(3):509-18. doi: 10.1249/MSS.0000000000000437.
PubMed 25003773Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.
PubMed 24183777Swift DL, McGee JE, Earnest CP, Carlisle E, Nygard M, Johannsen NM. The Effects of Exercise and Physical Activity on Weight Loss and Maintenance. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):206-213. doi: 10.1016/j.pcad.2018.07.014. Epub 2018 Jul 9.
PubMed 30003901Zhang Y, Yang Y, Zhu L, Zhu Q, Jia Y, Zhang L, Peng Q, Wang J, Liu J, Fan W, Wang J. Volumetric Deficit Within the Fronto-Limbic-Striatal Circuit in First-Episode Drug Naive Patients With Major Depression Disorder. Front Psychiatry. 2021 Jan 20;11:600583. doi: 10.3389/fpsyt.2020.600583. eCollection 2020.
PubMed 33551870
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality Education on Balance, Depression, Anxiety and Stress Parameters in Healthy Young Individuals
- ClinicalTrials.gov ID
- NCT05985096
- Acronym / sponsor ID
- A-2325
- Conditions
- Anxiety, Depression, Stress, Balanced
- Keywords
- Depression, Stress, Anxiety, Virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 5 Jun 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
If we examine the demographic data of the 2021 reports of the Turkish Statistical Institute (TUIK), we can see that the young population between the ages of 15 and 24 is 12,971,289 people, which is 15.3% of the total population. Considering the proportion of young population in our country, the evaluation of physical activity level has an important place, while the proportion of female university students who achieved sufficient physical activity level according to the scoring of the International Physical Activity Questionnaire (UFAA) was 8.5%, while the proportion of male students was 28.1% in previous studies (Arslan 2015). ).
We know from previous studies that achieving an adequate level of physical activity directly reduces the body mass index and indirectly reduces the cardiovascular risk associated with obesity (Swift 2018). Exercise reduces depression levels and the effects of depression. Although the neural mechanisms are not very clear, there are some predictions for physical exercise to reduce the level of depression (Gujral 2017). The hippocampus is an important cognitive and sensory centre, and it has been reported that hippocampal volume decreases by 5% in depressed individuals (Cole 2011). Hippocampal volume has been reported to increase rapidly with exercise (Bugg 2012).
The brain region most affected in major depressive disorder is the prefrontal cortex. After the prefrontal cortex is affected, symptoms such as negative affect and learned helplessness appear (Pizagalli 2021). Experimental studies in mice have shown that treadmill training creates new synaptic pathways in the prefrontal cortex and hippocampus (Mu 2022).
Another brain region affected by depression is the corpus striatum. Loss of corpus striatum volume is observed in patients with major depression (Zhang 2020). The volume of the corpus striatum modulates when physical exercise reaches a sufficient level. (Rotttensteiner 2015).
Adequate levels of physical activity not only reduce depression, but also prevent neural dysfunction that can occur as a result of depression. However, young people do not get enough exercise. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation.
The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people.
Detailed description
Our work will last 6 weeks and is planned as exercise for 1 hour a day, 2 days a week.
Group 1: The control group will do individual exercise. The monitoring of the physical exercises will be done with video recordings.
Physical exercises Stick exercises: Shoulder stick (wand) exercises aim to perform shoulder range of motion exercises by supporting the sore arm with a solid arm. Use the stick to make forward, side, backward, outward and inward movements as shown in the picture. Count to 5 at the end of each movement and return to the beginning (Puendgsuwan 2008).
Codman exercises: Step forward with one foot and lean forward on a stable surface such as a table. Release your arm using the weight: move it back and forth like a pendulum. c) Circle clockwise and counterclockwise (Cunningham 2020).
Squat exercises: With feet open at shoulder height, the person's back is against the wall and positioned 10 cm in front of the wall. The rolling pin on the shoulder is grasped with the hands. The person faces forward. The movement is performed by bending the hip and knee joints without disturbing the straightness of the back and without touching the wall. Then return to starting position, keeping the spine straight and extending the hip and knee joints. Perform 3 sets of 10 repetitions (Kubo 2019).
Tandem walking exercise: A straight line is drawn on the floor. From the person, 10 steps are taken to follow this straight line with the heel of the front foot to the tip of the back foot. 3 sets of eyes open and 3 sets of eyes closed (Cruz 2021).
Group 2: Virtual reality group. People in this group will be expected to meet their physical activity levels with Racket, Climb, Acron, Skiing, Cycling games using the Oculus Quest 2 VR goggles platform.
Virtual reality games Racket: Nx is a new type of game in VR that pushes the boundaries of what you can do with a racket and a ball. The game takes place inside a giant glass dome, the walls of which are lit up with targets that you have to destroy with the cannon. But this is no ordinary ball. If you hit it hard, it will crash into a wall, roll over, and bulldozers will crush everything in its path. Use the racket's hammer beam to retreat or aim the next hit exactly where you want it. Targets appear in waves and the aim is to destroy them all before you run out of energy. But targets aren't the only thing in the arena. That's why you need to hit quickly and accurately. But in this game, the aim is to teach you how to control the ball perfectly. It is an alternative to coordination exercises.
Climbing: The aim of this game is to simulate climbing. It can be used as an alternative to strengthening the upper limbs. From exploring mountain environments to scaling urban environments, the game is also designed to have the dual effect of feeling the excitement of climbing without ropes and experiencing the landscapes as you climb to new heights.
Acron: In this game, you take on the role of a large, ancient tree that is the sole guardian of golden acorns. In this simulation, he uses an arsenal of unique abilities across seven different maps to try and prevent golden acorns from being stolen. We plan to use this simulation as an alternative to lower extremity strengthening exercises.
Skiing: Start with your feet shoulder-width apart, arms at eye level and bent 90°. Then swing your arms down and back while squatting. Don't squat too deep and squeeze your core. Finally, swing your arms back to their original position while standing. Continue to squat and swing your arms vigorously. The aim of this simulation is to provide an alternative to squatting and wand exercises.
Cycling: How to play: Stand upright, keeping your core strong and engaged, and start 'cycling' with your arms. There are also two ways to do circular arm movements: with the arms at your sides, mostly as regular arm cycling moves, which will focus on the shoulders, chest and triceps muscles, or as boxing speedbag moves, with the forearms side by side at face level, which will focus on the forearms, triceps muscles and shoulder blades. The aim of this simulation is to provide an alternative to balance, stick and Codman exercises.
Questionnaires and tests to be used for evaluation Depression-Anxiety Stress Scale 21 (DASS 21): It is estimated that by 2020, depression, stress and anxiety-related disorders will be the second most common disease in the world. The prevalence of these disorders can also have a significant negative impact on countries' health expenditure, social harmony, business life and individuals. This scale will be used to measure the depression burden of students.
Motivation scale for participation in physical activity: This 16-question questionnaire assesses an individual's motivation to participate in physical activity. Questions 1-6 of the survey form the individual causes, 7-12 form the environmental causes and questions 13-16 form the dimension of irrationality. Questions 3,9,13,14,15,16 are reverse coded.
Repetitive joint position sense test: The test is scored during arm elevation positions that include 90° shoulder flexion and 90° shoulder abduction movements. For the shoulder flexion assessment, the individual is asked to stand facing the millimetre paper taped to the wall. The laser cursor is positioned 5 cm above the elbow joint so that wrist and elbow movements do not affect the measurements. The subject is asked to flex the shoulder joint to 90°. This shoulder movement is measured by the physiotherapist using a goniometer and the person is asked to maintain this position for 10 seconds with eyes open. The projection of the laser cursor is marked on millimetre paper. The 90° position is repeated 3 times with the eyes open and the person is asked to memorise this position. It is then returned to the starting position and the subject's eyes are closed. He is asked to repeat the same movement 3 times and the projection of the laser cursor is marked. For the abduction movement, the subject is asked to turn sideways towards the wall, with the head turned towards the wall, bringing the arm to 90° abduction and the angle is measured with a goniometer. The projections of the laser cursor are also marked. The starting point is assumed to be 0 and the projections of the points on the x and y axes are measured during the angle repetition. The deviation is calculated using the formula c=√x2+y2 (Düzgün 2011).
Star Balance Test: The Star Balance Test, originally called the Star Excursion Balance Test, is a reliable tool for measuring dynamic balance. Designed for the assessment of lower extremity injuries and disorders, it is also widely used to assess dynamic balance in sport. In addition, the Star Excursion Balance Test has been shown to have a high coefficient of internal reliability, but its coefficients of validity have not been investigated. The test is based on the ability to reach the farthest possible distance on the supporting leg with the free leg in 8 different directions and is a very high quality measure of dynamic balance performance in sport (Gribble 2013). Before starting the test, a dry and quiet environment that is not affected by changing weather conditions should be selected for the test. This is the most basic requirement for a valid and reliable test between repeated measurements.
Required Equipment
- A minimum of 2×2 meters of flat, dry and suitable Ground
- Test manager and scoring chart
- Flat adhesive tape (minimum 8 meters)
- Ruler or Metre Application: 4 strips cut to 2 metres are placed on the floor at an angle of 45 degrees. The subject should be barefoot if possible. Shoes affect the reliability of the test in repeated tests. The athlete waits in the centre of the star shape (the point where the lines intersect). If the right foot is chosen as the reach foot, the test direction is clockwise. For the left foot, the direction is counter-clockwise. The hands should be at the waist during the test and the position of the hands should not change during the test. If this is not the case, the athlete places the hands on the waist, repeats whichever line is left, and continues the test. The athlete reaches out as far as he can with his foot and lightly touches the strip with the tip of his toe. He then returns to the starting position (hands around his waist, feet in the air, on one leg). Then the other line is walked and a total of 8 lines are completed in this way. Each time, the examiner makes a mark with a pencil to measure the maximum point that the subject can touch at a later time. After the whole process has been repeated 3 times with the right foot, the left foot is switched and the process is repeated 3 times (Shaffer 2013). At the end of the test, the participant records the distances reached in the Cartex.
Nelson Hand Reaction Test: The Nelson hand reaction test can be measured using the ruler method. The subject is seated in a chair with the forearm and hand resting relaxed on the table. The tips of the thumb and forefinger are placed 8-10 cm from the table so that they are approximately parallel on the outside. The tips of the thumb and index finger should be horizontal to each other. The examiner holds the tip of the ruler between the thumb and index finger of the subject. The subject is instructed to look directly at the concentration zone (the black area between lines 0.120 and 0.30) and to catch the ruler when it is released. There are 20 trials, each starting after the 'ready' command. The result is read from the line at the top of the subject's thumb after the subject has caught the ruler. The lowest 5 and the highest 5 trials are discarded and the average of the remaining 10 trials is recorded as the result. The digits on the time scale represent thousandths of a second. The results are recorded as 5/1000 seconds (Musabaşoğlu 2008).
Mini Best Test: This test is used to evaluate the balance. The Mini Best (DDS) test has 14 parameters. Anticipatory postural control (standing up from sitting; toes up; standing on one leg), reactive postural control (compensatory corrective stepping forward; compensatory corrective stepping backward; compensatory corrective stepping sideways), sensory orientation (standing position (feet together); eyes open, hard surface; standing position (feet together): eyes closed, spongy surface; tilt - eyes closed), dynamic gait (change of walking speed; walking with horizontal head movements; turning while walking; stepping over an obstacle; double The task is evaluated with timed get up \& walk tests [ 3 metres walking).
Scoring: The test consists of 14 items, each scored from 0 to 2 out of a maximum of 28. "0' indicates the lowest level of function and '2' indicates the highest level of function. If the person requires the use of an assistive device for any item, that item is scored one level lower. If the person requires physical assistance to perform the item, score that item as "0". For item 3 (standing on one leg) and item 6 (compensatory stepping - lateral), record the score of only one side (low score). For item 3 (standing on one leg) take the best time from 2 attempts (each side separately). For item 14 (time to stand up and walk with double duty), the score should be reduced by one level if the person's gait slows by more than 10% between double duty and non-double duty SCI.
Measurement Evaluation and Statistical Analysis
- Sample size: Gpower 3.1. determined by power analysis using the programme. In the analysis (α=0.05, power (1-β) = 0.80, effect size= 0.8, and at least n=26 people should be included in the groups. It was set at n=30 in case of dropout.
- Number and names of groups in the study: Group 1: Control group Group 2: Virtual reality grou
- Properties to be measured: Depression, anxiety, stress parameters Balance Repetitive joint position sense Participation in physical activity Motivation Hand reaction
- Statistical analysis: The data in the study are analysed using 5 parameters (skewness-curvature, Std/Mean, Q-Q plots, histogram and Shapiro-Wilk test). The parameters with a score higher than 3 and a sufficient number of data are considered to be normally distributed and are presented as Mean±Standard Deviation (MEAN±STD).The Independent Samples T-test is used to compare two independent groups and the Related Samples T-test is used to compare dependent groups. Pearson correlation is used for correlation analysis of parametric data. Parameters with a score of 3 or less in the normal distribution analysis are considered non-parametric, and the Mann-Whitney U test is used for comparisons between two independent groups, the Wilcoxon test is used for comparisons between dependent groups, and Spearman Rho's correlation analysis is used for correlation analysis. In the study, α=0.05 and p<α are considered significant. The IBM SPSS 28.00 package programme will be used for statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Diagnostic Test: Virtual reality groupAdequate physical activity not only reduces depression, but also prevents the neural dysfunction that can occur as a result of depression. However, the level of physical activity among young people is not sufficient. Based on this fact, we believe that it is necessary to use 3D virtual reality applications to increase physical activity levels and exercise motivation. The aim of our study is to investigate the effect of virtual reality training on balance, depression, anxiety and stress parameters in healthy young people. |
| Control Group | No intervention | –The control group will perform individual exercise. The physical activity will be monitored with video recordings. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteering
- Being between 18-25 years old
Key exclusion criteria (3 listed)
- Having a musculoskeletal disease
- Having a systemic (cardiovascular, neurological) disease
- Not attending the training sessions more than once
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 reality groupParticipants in this group will be expected to meet their physical activity levels using the Oculus Quest 2 VR Goggles platform with Racket, Climb, Acron, Skiing, Cycling games. | Diagnostic test | Virtual Reality Group |
Primary outcome
Decrease in depression, anxiety stress parameters
Time frame: 6 weeks
The specified parameters are calculated using the DASS 21 scale before and after the intervention.
1 secondary outcome
Increased hand reaction
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 22404537Bugg JM, Shah K, Villareal DT, Head D. Cognitive and neural correlates of aerobic fitness in obese older adults. Exp Aging Res. 2012;38(2):131-45. doi: 10.1080/0361073X.2012.659995.
- Background: PubMed 21745692Cole J, Costafreda SG, McGuffin P, Fu CH. Hippocampal atrophy in first episode depression: a meta-analysis of magnetic resonance imaging studies. J Affect Disord. 2011 Nov;134(1-3):483-7. doi: 10.1016/j.jad.2011.05.057. Epub 2011 Jul 13.
- Background: PubMed 33430476Perez-de la Cruz S. Comparison between Three Therapeutic Options for the Treatment of Balance and Gait in Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 7;18(2):426. doi: 10.3390/ijerph18020426.
- Background: PubMed 32875297Cunningham G, Charbonnier C, Ladermann A, Chague S, Sonnabend DH. Shoulder Motion Analysis During Codman Pendulum Exercises. Arthrosc Sports Med Rehabil. 2020 Jun 26;2(4):e333-e339. doi: 10.1016/j.asmr.2020.04.013. eCollection 2020 Aug.
- Background: PubMed 24067151Gribble PA, Kelly SE, Refshauge KM, Hiller CE. Interrater reliability of the star excursion balance test. J Athl Train. 2013 Sep-Oct;48(5):621-6. doi: 10.4085/1062-6050-48.3.03. Epub 2013 Mar 19.
- Background: PubMed 29122145Gujral S, Aizenstein H, Reynolds CF 3rd, Butters MA, Erickson KI. Exercise effects on depression: Possible neural mechanisms. Gen Hosp Psychiatry. 2017 Nov;49:2-10. doi: 10.1016/j.genhosppsych.2017.04.012.
- Background: PubMed 31230110Kubo K, Ikebukuro T, Yata H. Effects of squat training with different depths on lower limb muscle volumes. Eur J Appl Physiol. 2019 Sep;119(9):1933-1942. doi: 10.1007/s00421-019-04181-y. Epub 2019 Jun 22.
- Background: PubMed 35053360Mu L, Cai J, Gu B, Yu L, Li C, Liu QS, Zhao L. Treadmill Exercise Prevents Decline in Spatial Learning and Memory in 3xTg-AD Mice through Enhancement of Structural Synaptic Plasticity of the Hippocampus and Prefrontal Cortex. Cells. 2022 Jan 12;11(2):244. doi: 10.3390/cells11020244.
- Background: PubMed 34341498Pizzagalli DA, Roberts AC. Prefrontal cortex and depression. Neuropsychopharmacology. 2022 Jan;47(1):225-246. doi: 10.1038/s41386-021-01101-7. Epub 2021 Aug 2.
- Background: PubMed 25003773Rottensteiner M, Leskinen T, Niskanen E, Aaltonen S, Mutikainen S, Wikgren J, Heikkila K, Kovanen V, Kainulainen H, Kaprio J, Tarkka IM, Kujala UM. Physical activity, fitness, glucose homeostasis, and brain morphology in twins. Med Sci Sports Exerc. 2015 Mar;47(3):509-18. doi: 10.1249/MSS.0000000000000437.
- Background: PubMed 24183777Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.
- Background: PubMed 30003901Swift DL, McGee JE, Earnest CP, Carlisle E, Nygard M, Johannsen NM. The Effects of Exercise and Physical Activity on Weight Loss and Maintenance. Prog Cardiovasc Dis. 2018 Jul-Aug;61(2):206-213. doi: 10.1016/j.pcad.2018.07.014. Epub 2018 Jul 9.
- Individual participant dataSharing planned: Yes
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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.
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 group in people with Anxiety and Depression, run by Ordu 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halil Yılmaz, PhD (+90 452 226 52 00 ext. 5216, halilyilmaz855@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in depression, anxiety stress parameters (time frame: 6 weeks). 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 NCT05985096, which also lists 13 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 14 Aug 2023.