Study Protocol for Mindfulness-Based Yoga Versus Physical Exercise on the Psychological Well-Being in Students With Early Visual Impairment: A Three-Armed, Multi-Centered, Randomized Controlled Trial.

Background People with visual impairment (VI) tend to face more psychological distress than normally sighted individuals due to mobility restrictions, fear of falling, and sleep disturbances. However, research to address these problems is rare. This study aims to investigate the effect of mindfulness-based yoga versus physical exercise on the psychological well-being of individuals with VI. Methods This study will be a single-blinded, three-armed, multicentered, randomized controlled trial (RCT). A total of 132 participants with VI (ages 15-25) will be recruited in the study and will be randomly assigned to either group 1 (mindfulness-based yoga), group 2 (physical exercise), or group 3 (wait-list control). Groups 1 and 2 will receive intervention for 40 hours (eight weeks, weekly five days, one hour/day), whereas group 3 will continue their daily activities as usual. The intervention will take place in the afternoon from Monday to Friday. The timing varies between 4-5 pm according to the different time schedules of the institutions of the blind. Three times, assessments will be conducted at T0 (baseline), T1 (eighth week at the completion of the intervention), and T2 (sixth month following the completion of the intervention). ANOVA will be used to find out the differences between groups; repeated measures ANOVA will be used to check within-group changes. Trial status The study was first screened in December 2021. The recruitment of participants has been completed in two centers covering 62 individuals with VI, and intervention started in August 2022. The data collection is still ongoing due to the nature of the study design, a specific demographic, complex logistics, and administrative bottlenecks. The study incorporates three different groups and a substantial sample size (n=132). The specific demographic, people with visual impairments, are rare and difficult to locate. In addition, a six-month follow-up assessment contributes to complex procedures while coordinating between various institutions and securing necessary authorizations. Discussion This study will be the first comprehensive RCT to investigate the psychological well-being of the VI population with various psychophysiological and hormonal parameters in multiple centers. The presence of physical exercise and a wait-list control group will further elucidate the potential mechanism of Mindfulness-based yoga. Mindfulness-based yoga can be integrated into educational and rehabilitation systems to enhance the well-being of individuals with VI.