| CTRI Number |
CTRI/2025/09/094681 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MINDFUL MEDITATION] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of mindful meditation on anxiety and uroflowmetry parameters in patients with benign prostate hypertrophy |
|
Scientific Title of Study
|
Effect of mindful meditation on anxiety and uroflowmetry parameters in patients with benign prostate hypertrophy: A quasi-experimental study. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMAN PAREEK |
| Designation |
PG NURSING STUDENT |
| Affiliation |
college of nursing AIIMS Jodhpur |
| Address |
Room no. 144, Ground floor, Hostel no.2, Main gate no.6, AIIMS Jodhpur, Heavy industrial area, phase 2, Basni Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9587060020 |
| Fax |
|
| Email |
amanpareek2309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nipin Kalal |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, AIIMS Jodhpur |
| Address |
Room no. 107, floor 1st, College of Nursing, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8955945598 |
| Fax |
|
| Email |
kalalnipin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nipin Kalal |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, AIIMS Jodhpur |
| Address |
Room no. 107, First Floor, College of Nursing, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8955945598 |
| Fax |
|
| Email |
kalalnipin@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 Nipin Kalal |
AIIMS, Jodhpur |
Room no. 307, OT 3rd floor, Department of Urology
Jodhpur
RAJASTHAN |
8955945598
kalalnipin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS, JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindful meditation |
Intervention: Mindful Meditation for Experimental Group Participants
Participants in the experimental group will receive a mindful meditation intervention in addition to standard care prior to undergoing the uroflowmetry procedure. This systematic practice emphasizes relaxation techniques, controlled breathing, and present-moment awareness. The purpose of the intervention is to explore its immediate effects on uroflowmetry parameters and anxiety levels in patients with benign prostatic hyperplasia (BPH).
The meditation session will take place in a calm, comfortable clinical setting and will last approximately 15 to 20 minutes. Patients will be seated comfortably, either in a semi-reclined position or on a chair with back support. They will be encouraged to close their eyes or maintain a soft gaze to minimize distractions. Following this session, patients will be asked to briefly practice the same mindfulness techniques before entering the uroflowmetry room and are also encouraged to continue the practice during the procedure.
The session begins with preparation, where patients are guided to find a relaxed sitting posture with their feet flat on the ground and hands resting gently on their lap. They are invited to close their eyes if comfortable and take slow, deep breaths to settle into a relaxed state. A brief introduction to mindfulness will be provided, explaining it as a method to foster relaxation and enhance present-moment awareness.
The guided meditation consists of three key components. The first is Focused Breathing, where patients are encouraged to take deep, slow breaths and focus their attention on the breath. Should distractions arise, they will be gently guided to return their focus to their breathing. The second component is Body Scan Relaxation, which involves mentally scanning the body from head to toe to identify areas of tension or discomfort. Patients are encouraged to observe these sensations without judgment. The third component, Heightened Awareness of Sensations, involves cultivating a non-judgmental awareness of bodily sensations, thoughts, and emotions as they occur in the present moment, thereby fostering a deeper connection with one’s current experience.
To conclude the session, patients will be guided to slowly bring their awareness back to their surroundings through deep breathing. They will be invited to gently open their eyes and stretch at their own pace, transitioning mindfully out of the meditation experience. |
| Comparator Agent |
Standard routine care without mindful meditation |
The comparator agent is the control group, which receives standard routine care without mindful meditation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Adult male patients with BPH who are 40 years of age or older, willing to participate in the study.
2. Patients who can follow the instructions.
3. Understand Hindi or English.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of depression, or anxiety disorder.
2. Patients undergone uroflowmetry procedures earlier will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Anxiety Levels:
To evaluate and compare the change in anxiety levels before and after the intervention of mindful meditation among patients with benign prostatic hypertrophy (BPH) in the experimental group versus the control group, using a validated anxiety assessment tool.
Improvement in Uroflowmetry Parameters:
To assess and compare the change in uroflowmetry parameters (such as Qmax, average flow rate, voided volume, and flow time) following mindful meditation among BPH patients in the experimental group versus the control group.
Correlation Between Anxiety and Uroflowmetry:
To determine the association between anxiety levels and uroflowmetry parameters among patients with BPH, identifying whether higher anxiety is related to poorer uroflowmetry outcomes.
|
AT THE TIME OF ENROLLMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/10/2025 |
| 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="0"
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 quasi-experimental study aims to evaluate the effect of mindful meditation on anxiety and uroflowmetry parameters among patients with benign prostate hypertrophy (BPH). Mindful meditation, a non-pharmacological intervention focusing on relaxation and awareness, is expected to reduce anxiety levels and improve urinary flow. The study will recruit patients diagnosed with BPH and allocate them into experimental and control groups. Anxiety will be measured using a self-structured tool, while uroflowmetry will assess urinary flow parameters. Findings may provide evidence for integrating mindful meditation into nursing practice as a supportive therapy to enhance quality of life in BPH patients. |