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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06028360
Other study ID # SSAHS 2023/02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date December 31, 2023

Study information

Verified date September 2023
Source Shalamar Institute of Health Sciences
Contact Masooma Gull, M.S.
Phone +92-42-111-205-205
Email masooma.gull@sihs.org.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this clinical trial is to observe the effect of Virtual Reality (VR) and Progressive muscle relaxation (PMR) in stressed individuals. Procedure: Students will be invited verbally and procedure will be explained to them. 20 students will be recruited randomly into control and experimental group. Stress will be predicted using multiple questionnaires. Pss is given before and after the intervention. The students in control group will be given 10 mins session of PMR for 3 consecutive days and in intervention group will be given 10 mins session of PMR followed by 8 mins session of VR for 3 consecutive days in which specific landscapes i.e mountains, forests, nightskies and beaches.


Description:

Introduction: As stress appears to be a natural human response to difficult situations prompting us to address challenges and threats in our lives, prolonged stress may cause the fight or flight response to over-ride body's normal physiology and produce multiple psychological and physiological symptoms resulting in various negative health conditions such as cardiovascular disorders, GIT disturbances, hypertension etc. Moreover, a global survey of adolescents in 72 countries found 66% of students reported feeling stressed about academics and 37% of students felt anxiety relating to schoolwork. Many stress reduction interventions such as Progressive Muscular Relaxation (PMR), mindfulness meditation, deep breathing exercises, and guided imagery have been shown to reduce stress levels among individuals and are being used as traditional relaxation interventions. Progressive muscle relaxation (PMR) originally known as Jacobson Muscle Relaxation Technique, was developed by Edmund Jacobson in the 1934. It is an actively engaging technique guiding the patients to consciously contract muscles to create tension and release it progressively. This is repeated until patients acquire complete relaxation. Many studies on PMR have proven it to be beneficial in decreasing stress and anxiety levels in many adults as well as children worldwide. With emerging technology, innovative ideas, such as the use of VR (Virtual Reality) for stress management, have also been considered and studied. According to Cruz-Neira (1993), Virtual reality refers to immersive, interactive, multisensory, viewer-centered, 3D computer generated environments and the combination of technologies required building environments. In the healthcare sector, VR has been proved beneficial for balance and cognition training in cerebral palsy and stroke, and also has been observed to mitigate acute and chronic pain. It can provide rehabilitation, motivation and entertainment all at once. Further studies on its immersive effect suggest it to be helpful in stress management. Natural environments (forests, beaches, mountains etc ) viewed through VR, have shown to help individuals reduce their stress levels, anxiety disorders, and phobias. However, there is little research on individual preferences of different VR landscapes. In Asia, research relevant to VR has been shown to have a positive effect on stress management in individuals with high stress and mood disorders. Effect of forest and water landscapes on stress management has also been discussed earlier. However, area for more research still remains. In Pakistan, multiple researches have been conducted on the use of VR in health care and as a rehabilitative intervention for diseases such as stroke, parkinsons, cerebral palsy and amblyopia, but very limited evidence is available on the effect of VR on stress management. No such research has been conducted in this region or in our institution prior to our study. A study conducted in India showed that the PSS score decreased from mean 22.2 to 16.5 while another study conducted in India indicated that PMR and talk therapy in college students, reduced percieved stress from PSS score of 32.30 to 23.03. The purpose of our research is to investigate the effect of VR in stress management, the individual preferences of landscapes and its comparison with traditional relaxation technique such as Progressive Muscle Relaxation (PMR). This will help health-care workers improve stress management in a technology driven community. Statistical analysis: data will be entered and analyzed using SPSS 25. Numerical data like age, PSS score will be presented in the form of mean ± S.D whereas qualitative data like gender, Pre/Post intervention stress etc. will be presented in the form of Frequency (Percentage). After fulfilling parametric assumptions, Repeated measure ANOVA will be applied. Potential benefits: 1. The subjects receiving the interventions will experience reduced stress and anxiety. 2. The subjects will be introduced to an innovative and immersive technology i.e., VR. 3. A step will be taken forward towards the use of technology in stress management, along with a traditional relaxation technique such as Progressive muscle relaxation (PMR). 4. The use of VR for stress management is cost effective and time saving. Potential risks: 1. Motion Sickness It will be tried to minimize by excluding the susceptible subjects, using Visually Induced Motion Sickness Susceptibility Questionnaire (VIMSSQ). Also subjects with any psychological or in-corrected eye sight will not be included in the study. In case the above mentioned risk develops during the intervention, the subject will be given rest. 2. Increased Drop Out Rate If the required sample size is not met due to high drop out rate, new participants will be recruited and the procedure will be repeated until required amount of data is available.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date November 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - Students of either sex, aged between 18-24 years - Students with Stress (through perceived stress scale PSS, any individual with a score above 14) Exclusion Criteria: - Students more susceptible to motion sickness (Through VIMSSQ), - Students with in-corrected eye-sight, - Students with phobias relevant to landscapes/views of mountains, forests, beaches and night-skies.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Progressive Muscle Relaxation
Intervention will be applied for 15-20 minutes 3 consecutive days a week for 1 week
Device:
Virtual Reality Therapy
Therapy through VR will be given for 8 minutes 3 times a week on consecutively for 1 week

Locations

Country Name City State
Pakistan Shalamar Medical and Dental College Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Shalamar Institute of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12. — View Citation

Allison S, Irwin Hamilton K, Yuan Y, Wallis Hague G. Assessment of Progressive Muscle Relaxation (PMR) as a Stress-Reducing Technique for First-Year Veterinary Students. J Vet Med Educ. 2020 Dec;47(6):737-744. doi: 10.3138/jvme.2018-0013. Epub 2019 Nov 15. — View Citation

Browning MHEM, Shin S, Drong G, McAnirlin O, Gagnon RJ, Ranganathan S, Sindelar K, Hoptman D, Bratman GN, Yuan S, Prabhu VG, Heller W. Daily exposure to virtual nature reduces symptoms of anxiety in college students. Sci Rep. 2023 Jan 23;13(1):1239. doi: 10.1038/s41598-023-28070-9. — View Citation

Gao T, Zhang T, Zhu L, Gao Y, Qiu L. Exploring Psychophysiological Restoration and Individual Preference in the Different Environments Based on Virtual Reality. Int J Environ Res Public Health. 2019 Aug 26;16(17):3102. doi: 10.3390/ijerph16173102. — View Citation

Kashif M, Ahmad A, Bandpei MAM, Farooq M, Iram H, E Fatima R. Systematic review of the application of virtual reality to improve balance, gait and motor function in patients with Parkinson's disease. Medicine (Baltimore). 2022 Aug 5;101(31):e29212. doi: 10.1097/MD.0000000000029212. — View Citation

Keshavarz B, Murovec B, Mohanathas N, Golding JF. The Visually Induced Motion Sickness Susceptibility Questionnaire (VIMSSQ): Estimating Individual Susceptibility to Motion Sickness-Like Symptoms When Using Visual Devices. Hum Factors. 2023 Feb;65(1):107-124. doi: 10.1177/00187208211008687. Epub 2021 Apr 19. — View Citation

Levenstein S, Prantera C, Varvo V, Scribano ML, Berto E, Luzi C, Andreoli A. Development of the Perceived Stress Questionnaire: a new tool for psychosomatic research. J Psychosom Res. 1993 Jan;37(1):19-32. doi: 10.1016/0022-3999(93)90120-5. — View Citation

Ruotolo I, Berardi A, Sellitto G, Panuccio F, Polimeni A, Valente D, Galeoto G. Criterion Validity and Reliability of SF-12 Health Survey Version 2 (SF-12v2) in a Student Population during COVID-19 Pandemic: A Cross-Sectional Study. Depress Res Treat. 2021 Aug 4;2021:6624378. doi: 10.1155/2021/6624378. eCollection 2021. — View Citation

Wang X, Shi Y, Zhang B, Chiang Y. The Influence of Forest Resting Environments on Stress Using Virtual Reality. Int J Environ Res Public Health. 2019 Sep 5;16(18):3263. doi: 10.3390/ijerph16183263. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stress Reduction Reduction in Perceived Stress scale(PSS) from the previous reading will be considered as stress reduction. information will be collected before and after the treatment on each day. The scoring of Perceived Stress scale(PSS) ranges between 0-40, where 0-13 means low stress, 14-26 means moderate stress and 27-40 would be considered as high perceived stress the outcome will be determine at the base line of the treatment and at the 3rd day after initiation oftreatment
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