| 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
|
|
|
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
|
|
|
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
|
|
|
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. |