| CTRI Number |
CTRI/2025/09/094039 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mindfulness Meditation Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of mindfulness meditation in patients with high blood pressure and mental stress |
|
Scientific Title of Study
|
A Study on the Effectiveness of Mindfulness Meditation in Middle-Aged Hypertensive Patients with Stress |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neelanjan Sannigrahi |
| Designation |
Assistant Professor |
| Affiliation |
Gouri Devi Institute of Medical Science and Hospital |
| Address |
Gouri Devi Institute of Medical Science and Hospital NH2 Rajbandh Durgapur 713212 Dist Paschim Bardhaman WB
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9932697308 |
| Fax |
03432520881 |
| Email |
drneelsan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neelanjan Sannigrahi |
| Designation |
Assistant Professor |
| Affiliation |
Gouri Devi Institute of Medical Science and Hospital |
| Address |
Gouri Devi Institute of Medical Science and Hospital NH2 Rajbandh Durgapur 713212 Dist Paschim Bardhaman WB
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9932697308 |
| Fax |
03432520881 |
| Email |
drneelsan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neelanjan Sannigrahi |
| Designation |
Assistant Professor |
| Affiliation |
Gouri Devi Institute of Medical Science and Hospital |
| Address |
Gouri Devi Institute of Medical Science and Hospital NH2 Rajbandh Durgapur 713212 Dist Paschim Bardhaman WB
Barddhaman
WEST BENGAL
713212
India |
| Phone |
9932697308 |
| Fax |
03432520881 |
| Email |
drneelsan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gouri Devi Institute of Medical Sciences and Hospital |
| Address |
Gouri Devi Institute of Medical Sciences and Hospital NH2 Rajbandh Durgapur Paschim Bardhaman West Bengal 713212 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neelanjan Sannigrahi |
Gouri Devi Institute of Medical Sciences and Hospital |
Assistant Professor Room Department of Physiology Academic Building GIMSH
Barddhaman
WEST BENGAL |
9932697308
03432520881
drneelsan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Ethics Committee GIMSH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10-I16||Hypertensive diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health Education |
Participants in the control group will receive only weekly health education sessions (2 hours per week) for 10 weeks, with no mindfulness meditation. Patients will be provided with individualized counseling on weight management, which will include guidance on calorie restriction tailored to their Body Mass Index (BMI). They will also be encouraged to engage in regular moderate physical exercise, such as brisk walking, cycling for at least 30 minutes on most days of the week. In addition, patients will be advised to restrict their daily salt intake to less than 6 grams, in line with international hypertension management guidelines. |
| Intervention |
Mindfulness Meditation |
Mindfulness Meditation Technique
1. Sit comfortably: find a place that gives you a stable solid comfortable seat.
2. Observe what your legs are doing: if you are sitting on a cushion cross your legs comfortably in front of you. If you are sitting on a chair then rest the soles of your feet on the floor.
3. Keep your upper body straight: you should not be stiff and should maintain the natural curvature of your spine.
4. Observe your arms: keep your upper arms parallel to your upper body and rest the palms of your hands on your legs wherever it feels most natural.
5. Soften your gaze: your chin should drop a little and your gaze should fall gently downward. There is no need to close your eyes, it can be kept open without focusing on any particular thing.
6. Feel your breath: you should focus on your physical sensation of breathing, the air that is moving through your nose or mouth, the rising and falling of your belly or your chest.
7. Notice when your mind wanders from your breath. Undeniably, your attention will leave the breath and wander to other places but you should not worry about it. Your thinking should not be blocked or eliminated rather when you notice your mind wandering, gently return your attention to the breath.
8. Be kind about your wandering mind: You may find your mind constantly wandering which is very normal, therefore instead of wrestling with your thoughts practice observing them without reacting. Just sit and pay attention. Without any judgement or expectation come back to your breath over and over again.
9. When you are ready gently lift your gaze: If your eyes are closed, open them, after a moment notice the sounds in the environment. Observe how your body feels right now, notice your thoughts and emotions. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.
Middle aged patients (Men and Women both) with age group 45 to 60 years.
2.
PSLES Score of the patients should be more than 200.
3.
Patients who are suffering with hypertension (systolic BP more than 140 mm of Hg and Diastolic BP more than 90 mm of Hg) for at least 6 months of duration will be selected.
4.
Patients who refuse to take anti-hypertensives, want only lifestyle modification for BP reduction will be selected. |
|
| ExclusionCriteria |
| Details |
1.
Patients who are physically unfit to take part in the project.
2.
Patient with end stage life threatening diseases.
3.
Patients suffering with severe myocardial infarction, cerebral infarction, cirrhosis, uraemia.
4.
Patients with hearing and vision impairment.
5.
Patients who are taking anti psychotics, anti-anxiety, and antidepressive medications within last 3 months.
6.
Patients with substance abuse.
7.
Patients suffering from Alzheimer’s disease or any type of dementia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Presumptive live event Stress
scale (PSLES) score |
0 week, after completion of 5 weeks, after completion of 10 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fall in Systolic Blood Pressure (SBP) |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
28/11/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study will evaluate the effectiveness of a mindfulness-based intervention (Mindfulness Meditation) in reducing blood pressure and stress levels among hypertensive individuals. A total of 260 middle-aged participants (aged 45 to 60 years), diagnosed with hypertension (systolic BP > 140 mm Hg and diastolic BP > 90 mm Hg) for at least 6 months and having a Presumptive Life Event Stress (PSLES) score greater than 200, will be enrolled in the study. This is a single blind randomized controlled trial with intervention involving two equal groups (n = 130 each) — one receiving mindfulness meditation intervention (treatment group) and the other receiving Health education talk (control group). The control group will receive weekly health education sessions lasting 2 hours, while the study group will receive daily mindfulness meditation sessions (30 minutes per day) in addition to the same health education. Both groups will undergo the respective interventions for 10 weeks. Blood pressure and stress levels will be measured before and after the intervention. Stress will be assessed using the Perceived Stress Scale (PSS) developed by Sheldon Cohen. The study will evaluate whether the mindfulness-based intervention leads to a statistically significant reduction in both blood pressure and perceived stress in the intervention group compared to the control group. |