NCT06028360

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1 month

First QC Date

August 31, 2023

Last Update Submit

September 25, 2023

Conditions

Keywords

Psychological stressprogressive muscle relaxation (PMR)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Progressive Muscle Relaxation

ACTIVE COMPARATOR

Progressive muscle relaxation will be applied for 15-20 minutes for 3 consecutive days for 1 week.

Other: Progressive Muscle Relaxation

Virtual Reality

EXPERIMENTAL

Virtual reality session will be given for 8 mins for 3 consecutive days for 1 week.

Other: Progressive Muscle RelaxationDevice: Virtual Reality Therapy

Interventions

Intervention will be applied for 15-20 minutes 3 consecutive days a week for 1 week

Also known as: PMR
Progressive Muscle RelaxationVirtual Reality

Therapy through VR will be given for 8 minutes 3 times a week on consecutively for 1 week

Also known as: VR Therapy
Virtual Reality

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Students of either sex, aged between 18-24 years
  • Students with Stress (through perceived stress scale PSS, any individual with a score above 14)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar Medical and Dental College

Lahore, Punjab Province, 46994, Pakistan

RECRUITING

Related Publications (9)

  • 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.

    PMID: 31455015BACKGROUND
  • 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.

    PMID: 31491931BACKGROUND
  • 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.

    PMID: 31738679BACKGROUND
  • 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.

    PMID: 34394986BACKGROUND
  • 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.

    PMID: 8421257BACKGROUND
  • 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.

    PMID: 33874752BACKGROUND
  • 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.

    PMID: 31306747BACKGROUND
  • 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.

    PMID: 36690698BACKGROUND
  • 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.

    PMID: 35945738BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Reema Khanam, DPT

    Shalamar Medical and Dental College

    PRINCIPAL INVESTIGATOR
  • Laiba Khan, DPT

    Shalamar Medical and Dental College

    PRINCIPAL INVESTIGATOR
  • Maha Sohail, DPT

    Shalamar Medical and Dental College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The participants were blind to allocation. They were allocated by simple randomization through lottery method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Control Trial with a Control and an Experimental group that will be given intervention 3 consecutive days.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 8, 2023

Study Start

October 1, 2023

Primary Completion

November 10, 2023

Study Completion

December 31, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations