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CTRI Number  CTRI/2025/12/098917 [Registered on: 11/12/2025] Trial Registered Prospectively
Last Modified On: 11/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of meditation on sleep quality in older adults with malignancy/cancer 
Scientific Title of Study   Impact of M Health based meditation on sleep quality in older adults with solid organ malignancy: A pilot randomized controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Srishti Sachidanand 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Geriatric Medicine AIIMS Rishikesh
AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India 
Phone  8894445708  
Fax    
Email  drsrishti.aiims@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MONIKA PATHANIA 
Designation  ADDITIONAL PROFESSOR 
Affiliation  AIIMS Rishikesh 
Address  Department of Geriatric Medicine, AIIMS Rishikesh, Uttrakhand, India

Dehradun
UTTARANCHAL
249203
India 
Phone  8126021556  
Fax    
Email  anshupathania27@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Srishti Sachidanand 
Designation  Junior Resident 
Affiliation  AIIMS Rishikesh 
Address  Department of Geriatric Medicine AIIMS Rishikesh
AIIMS Rishikesh

UTTARANCHAL
249203
India 
Phone  8894445708  
Fax    
Email  drsrishti.aiims@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  AIIMS Rishikesh, DISTRICT DEHRADUN, UTTRAKHAND, INDIA (PIN CODE 249203) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Srishti Sachidanand  AIIMS Rishikesh  Department of Geriatric Medicine level 2 OPD
Dehradun
UTTARANCHAL 
8894445708

drsrishti.aiims@gmail.com 
Srishti Sachidanand  AIIMS Rishikesh  Department of Geriatric Medicine Level 6 ward
Dehradun
UTTARANCHAL 
8894445708

drsrishti.aiims@gmail.com 
Srishti Sachidanand  AIIMS Rishikesh  Department of Oncology/Hematology Level3 OPD
Dehradun
UTTARANCHAL 
8894445708

drsrishti.aiims@gmail.com 
Srishti Sachidanand  AIIMS Rishikesh  Department of Oncology /Hematology ward Level 4
Dehradun
UTTARANCHAL 
8894445708

drsrishti.aiims@gmail.com 
Srishti Sachidanand  AIIMS Rishikesh  Department of Radiation Oncology
Garhwal
UTTARANCHAL 
8894445708

drsrishti.aiims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ETHICS COMMITTEE AIIMS RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  meditation for 12 weeks  mobile and offline meditation 
Comparator Agent  standard sleep hygiene  Maintain a consistent sleep schedule by going to bed and waking up at the same time every day Create a relaxing bedtime routine such as reading or listening to calming music Ensure the bedroom environment is quiet, dark and comfortable Keep the bedroom temperature cool and pleasant Avoid caffeine containing beverages in the late afternoon and evening Limit screen exposure from mobile phones, televisions and laptops at least one hour before bedtime Avoid heavy meals, spicy food and excessive fluid intake close to bedtime Engage in regular physical activity during the day, preferably in the morning or afternoon Avoid daytime naps longer than twenty to thirty minutes Reduce exposure to bright lights in the evening Avoid alcohol or nicotine close to bedtime Manage stress through relaxation techniques such as meditation or deep breathing Get natural sunlight exposure in the morning to regulate the sleep wake cycle 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details 
Patients of age sixty years and above

Diagnosed case of solid organ malignancy

Willing to use a smartphone application with or without assistance

Baseline Pittsburgh Sleep Quality Index score greater than five, indicative of poor sleep quality

Willingness to participate and provide written informed consent 
 
ExclusionCriteria 
Details  Significant cognitive impairment, defined as HMSE score less than twenty

Diagnosed with major psychiatric illness or currently on antipsychotics, tricyclic antidepressants or selective serotonin reuptake inhibitors

Use of sedatives or hypnotics such as benzodiazepines or antihistaminic agents within the past two weeks

Diagnosed cases of restless leg syndrome or obstructive sleep apnoea 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Sleep quality using Pittsburgh sleep quality index  Baseline, week 6, week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the impact on overall quality of life using the EORTC QLQ-C30 questionnaire.
2. To compare effect of 12 weeks mobile based meditation intervention on mental wellbeing in older patients with solid organ malignancy in comparison to the control group using GDS 15 questionnaire.
To compare effect of 12 weeks mobile based meditation intervention on cognition in older patients with solid organ malignancy in comparison to the control group using HMSE questionnaire. 
Baseline , 6th week, 12th week 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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