Impact of M Health based meditation on sleep quality in older adults with solid organ malignancy: A pilot randomized controlled trial

This thesis presents a pilot randomized controlled trial from the Department of Geriatric Medicine at AIIMS Rishikesh. The aim is to study whether a mobile phone based meditation program can improve sleep quality in older adults with solid organ malignancy. Sleep problems are common in cancer patients and are often worsened by pain, treatment, emotional distress and hospitalisation. In older adults, sedative medicines carry risks such as confusion, falls and poor functional recovery. This makes non drug options like meditation an important area to explore.

The literature reviewed shows that sleep disturbance affects nearly sixty percent of cancer patients. Studies also show that frequent use of sleep medicines in older adults may increase the risk of dementia. Early trials in non cancer elderly populations show that mindfulness based meditation can improve sleep and daytime functioning. However, there is very limited research on meditation delivered through mobile health apps in elderly Indian cancer patients.

The study will recruit older adults from geriatric medicine and medical oncology units at AIIMS Rishikesh. The inclusion criteria are age sixty years or more, confirmed solid organ malignancy, poor sleep quality with Pittsburgh Sleep Quality Index score above five, ability or willingness to use a smartphone app and written informed consent. The exclusion criteria are significant cognitive impairment with HMSE score below twenty, major psychiatric illness, use of antipsychotics, tricyclic antidepressants or selective serotonin reuptake inhibitors, use of sedatives or antihistaminics in the past two weeks, diagnosed restless leg syndrome, diagnosed obstructive sleep apnea, use of melatonin in the last four weeks and practice of structured meditation in the past one month.

The sample size was calculated using G Power software based on earlier research where meditation showed a strong effect on sleep. After adjusting for expected dropouts, the final sample size is seventy two participants. These will be randomly assigned in equal numbers with thirty six in the intervention group and thirty six in the control group. The intervention group will receive a twelve week app based meditation programme while the control group will receive standard care without any specific sleep intervention.

The study will measure outcomes using validated tools. The primary outcome is sleep quality assessed with the Pittsburgh Sleep Quality Index. Secondary outcomes are mental wellbeing measured by the fifteen item Geriatric Depression Scale and overall quality of life measured by the EORTC QLQ C thirty questionnaire. Data will be analysed using appropriate statistical tests depending on normality of distribution. The study is self funded and approved by the Institutional Ethics Committee.

This trial is expected to provide early evidence on whether mobile health based meditation can be a simple, safe and culturally acceptable method to improve sleep in elderly cancer patients. Positive results could reduce the use of sedatives in this vulnerable group and can support future large scale studies across multiple centres.