Randomization and allocation concealment<\/p>\n
Randomization was performed using MedCalc 14 software, generating a computer-based sequence to ensure unbiased group assignment. Participants had equal chances of being allocated to VR or control groups. An independent researcher, uninvolved in intervention or assessment, managed group assignments. Allocation concealment was maintained using opaque envelopes, keeping assignments confidential until intervention, preventing team bias.<\/p>\n
Blinding inability<\/p>\n
Blinding was not feasible due to the visible nature of VR intervention, so participants and researchers were aware of group allocation, posing potential bias. To mitigate this, rigorous randomization and allocation concealment were applied. ata were analyzed using Statistical Package for the Social Sciences (SPSS) version 20. Descriptive statistics and normality tests were performed. Independent and paired t-tests, Chi-square tests, effect sizes, and Cronbach\u2019s alpha were used based on data type and research questions.<\/p>\n
Control of confounding variables<\/p>\n
Potential confounders (e.g., age, gender, BMI, baseline pain, functional scores) were controlled by strict inclusion\/exclusion criteria. Homogeneity between groups was verified using t-tests and chi-square tests, showing no significant baseline differences (p\u2009>\u20090.05). Intention-to-treat analysis was applied. Missing data were handled using multiple imputation.<\/p>\n
InterventionsVR group<\/p>\n
“The VR group received standard physiotherapy modalities, including electrotherapy and heat application, alongside lumbar exercise training. Exercises demonstrated during the initial session were later performed using the VR headset. A video with 13 different’Back School Exercises’was shown through the headset, with each exercise repeated at least five times. The first exercise was selected based on the patient’s preference and condition. To ensure hygiene, hygienic head pads were used with the VR headset. The researcher was present to intervene in case of emergency.<\/p>\n
Control group<\/p>\n
The control group received standard physiotherapy modalities, including electrotherapy and heat application, along with lumbar exercise training aimed at improving flexibility, strength, and mobility of the lumbar spine. These exercises were performed in the exercise room during scheduled appointments, without the VR headset. After the study, interested control group patients were offered the opportunity to perform exercises using the VR headset.<\/p>\n
Intervention detailsControl group<\/p>\n
Participants in the control group received a single, 30-min educational session. This session was delivered through a PowerPoint presentation, direct instruction, and a question-and-answer format. The education covered the anatomy of the lower back, causes of lumbar disc herniation, preventive measures, and recommended lumbar exercises. Following the session, participants independently performed the learned exercises over a total of 28 sessions without the use of virtual reality glasses.<\/p>\n
Study Group (SG)<\/p>\n
Participants underwent VR-based exercise therapy twice daily for 28 sessions. Sessions started at\u2009~\u200925\u00a0min, reducing to\u2009~\u200920\u00a0min from week two as strength and flexibility improved. Exercise intensity increased progressively with gains in joint mobility, muscle strength, and movement familiarity. VR videos recorded with a 360\u00b0 GoPro Max showed four physical therapists demonstrating exercises simultaneously, guided verbally by an instructor. Each exercise was repeated five times per session, with two sessions daily throughout the intervention.<\/p>\n
Adherence monitoring<\/p>\n
Patient adherence was tracked via daily attendance records and researcher supervision. Participants reported any exercise completion barriers. Adherence rate was calculated as the percentage of completed sessions out of the planned 28.<\/p>\n
Number and duration of exercise practices<\/p>\n
The standard physical therapy for LDH lasts 3\u00a0weeks (15 weekdays). With the first day reserved for lumbar education, the VR group (SG) had 14\u00a0days for exercise therapy, completing two sessions daily, totaling 28 sessions. Patients wore comfortable clothing, and sessions were paused if needed, resuming from the last completed movement.<\/p>\n
Intervention environment and materials<\/p>\n
Exercise Room: A 5\u2009\u00d7\u20094 m2 room equipped with a mat and a VR headset for lumbar exercises. No other equipment was used; safety protocols were observed.<\/p>\n
Lumbar health protection booklet<\/p>\n
Prepared from back school programs, it details lumbar anatomy, posture, and protective exercises with text and illustrations. Reviewed by ten experts prior to use.<\/p>\n
Virtual reality headset<\/p>\n
Device specs included 64\u00a0GB storage, 2560\u2009\u00d7\u20091440 resolution, and 470\u00a0g weight. Thirteen instructor-led lumbar exercise videos were preloaded.<\/p>\n
Outcome measuresQuestionnaire<\/p>\n
A 20-item questionnaire developed based on the literature [2<\/a>, 27<\/a>, 28<\/a>].<\/p>\n Visual Analog Scale (VAS)<\/p>\n Originally developed by Hayes and Patterson in 1921 to assess pain intensity [43<\/a>]. Participants rate their pain on a 10\u00a0cm scale, where 1\u20134 indicates mild pain, 5\u20136 moderate pain, and 7\u201310 severe pain [44<\/a>]. In this study, the VAS was specifically used to assess low back pain intensity in individuals with lumbar disc herniation.<\/p>\n Oswestry Disability Index (ODI)<\/p>\n Created by Fairbank et al. in 1980 to assess disability from low back pain [45<\/a>]. Scores are between 0\u2013100%, with higher scores indicating more severe disability. The Cronbach\u2019s \u03b1 coefficient in this study was 0.92.<\/p>\n SF-36 quality of life scale<\/p>\n Developed by Ware in 1987 to assess the physical and mental health-related quality of life [46<\/a>]. It consists of 36 questions across 8 sub-dimensions: Physical Function, Social Function, Physical Role Function, Emotional Role Function, Mental Health, Energy and Fatigue, Pain, and General Health. The scores range from 0\u2013100, with higher scores indicating better health. The Cronbach\u2019s \u03b1 for this study ranged from 0.41 to 0.90. The Emotional Role Function sub-dimension was excluded due to low reliability.<\/p>\n Fall risk measurement<\/p>\n Calculated using the Tetrax FB posturography device (Model: Tetrax FB, Manufacturer: Sunlight Medical). The patient places their bare feet on designated pressure areas, and a computer program calculates the fall risk score. Scores are categorized as”Mild Fall Risk”(0\u201336%),”Medium Fall Risk”(36\u201358%), or”High Fall Risk”(58\u2013100%) [47<\/a>].<\/p>\n Variables of the studyIndependent variable<\/p>\n Exercise performed using VR headsets.<\/p>\n Dependent variables<\/p>\n Visual Analog Scale (VAS), Oswestry Disability Index (ODI), quality of life scores, and fall risk scores.<\/p>\n Data collection<\/p>\n Conducted via face-to-face interviews using standardized tools, gathering demographic, clinical, pain, medication, and adherence data.<\/p>\n Ethical principles<\/p>\n Approved by Atat\u00fcrk University Ethics Committee; participants provided informed consent and were informed of withdrawal rights. Study adhered to the Declaration of Helsinki and was registered (NCT05463588). Participants completed questionnaires as part of data collection; nevertheless, patients and\/or the public were not involved in the design, conduct, reporting, or dissemination plans of this research. No adverse events or harms were recorded or reported during the intervention period. Participant safety was observed closely by the research team during the study. No important changes were made to the trial protocol after the onset of the study.<\/p>\n Statistical analysis<\/p>\n Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 20. Descriptive statistics and normality tests were performed. Independent and paired t-tests, Chi-square tests, effect sizes, and Cronbach\u2019s alpha were used based on data type and research questions. No additional analyses were completed.<\/p>\n CONSORT flow diagram<\/p>\n (Fig.\u00a01<\/a> CONSORT diagram).<\/p>\n
![\"figure](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/10\/12891_2025_9130_Fig1_HTML.png\")
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