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CTRI Number  CTRI/2018/04/012999 [Registered on: 04/04/2018] Trial Registered Retrospectively
Last Modified On: 24/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of preoperative meditation techniques on anxiety level of patients undergoing Cataract(motiabind) Surgery. 
Scientific Title of Study   Effect of Psychoneurobics (Meditation technique) on level of Anxiety in Patients Undergoing Cataract Surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubhra Agrawal Gupta 
Designation  Associate Professor 
Affiliation  Dept.of Community Medicine, Pt.J.N.M. Medical College 
Address  Dept.of Community Medicine, Pt.J.N.M. Medical College,Raipur.

Raipur
CHHATTISGARH
492001
India 
Phone  9893185621  
Fax    
Email  shubhraagrawalgupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shubhra Agrawal Gupta 
Designation  Associate Professor 
Affiliation  Dept.of Community Medicine, Pt.J.N.M. Medical College 
Address  Dept.of Community Medicine, Pt.J.N.M. Medical College,Raipur.

Raipur
CHHATTISGARH
492001
India 
Phone  9893185621  
Fax    
Email  shubhraagrawalgupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shubhra Agrawal Gupta 
Designation  Associate Professor 
Affiliation  Dept.of Community Medicine, Pt.J.N.M. Medical College 
Address  Dept.of Community Medicine, Pt.J.N.M. Medical College,Raipur.

Raipur
CHHATTISGARH
492001
India 
Phone  9893185621  
Fax    
Email  shubhraagrawalgupta@gmail.com  
 
Source of Monetary or Material Support  
Self-sponsored. Shri Ganesh Vinayak Eye hospital, Pachpedi Naka, Raipur,Chhattisgarh,492001. 
 
Primary Sponsor  
Name  Shubhra Agrawal Gupta 
Address  Dept. Of Community Medicine,Pt.J.N.M Medical College,Raipur,492001. 
Type of Sponsor  Other [Self-sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anil Gupta  Shri Ganesh Vinayak Eye Hospital  Counselling and Training Hall,Dept. Of Ophthalmology,SGV Eye hospital,Pachpedi Naka,Near Colours Mall,Raipur,492001
Raipur
CHHATTISGARH 
9893185622

dranil1977@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Ganesh Vinayak Eye hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Catract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Neurobic Spa part of Psycho-neurobics  In this group, Psycho-neurobic training was given to the patients before undergoing surgery for one day(Three hour session). Basic concepts and training were given to patients as well as to family member and they were advised certain instructions to be followed. The patients were advised to practice Psycho-neurobic (Neurobic spa) Meditation in short sessions of half an hour.  
Comparator Agent  Without neurobic spa part of psychoneurobics  Not receiving the intervention.The patients received only routine counseling regarding the surgery one week before operation.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1)Above 40 yrs of age
2)Having cataract
3)Either fee from hypertension and diabetes mellitus or Having controlled hypertension and diabetes mellitus.
4)Planned for SICS / Phaco-emulcification mode of surgery performed under Peribulbar anaesthesia(local anaesthesia)
5)Given consent. 
 
ExclusionCriteria 
Details  1) <40 yrs
2) Not willing to participate in study
3) Associated Ocular or Systemic co-morbidities and uncontrolled Diabetes mellitus and Hypertension 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Amsterdam Preoperative Anxiety and Information Scale(APAIS) score
 
1-Before intervention and cataract surgery
2-After intervention and before cataract surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Happiness score through happiness stress stethoscope,Blood pressure sugar, heart rate, respiratory rate.  1-Before intervention and cataract surgery
2-After intervention and before cataract surgery
3-After cataract surgery 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   Phase 2 
Date of First Enrollment (India)   25/02/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Anxiety is an unpleasant emotional experience that involves feelings of tension, apprehension, nervousness and high autonomic activity. Major life changes are among factors that cause anxiety, and one of these changes is surgery.

Cataract surgery is one of the most common operations performed and one of the safest and most effective. Most cataract surgery is now performed under local anesthesia on a day-care basis. As patients are fully conscious during the procedure, it is important that they remain still. Everyone is anxious when facing cataract surgery because of the fear of unknown.

 

Anxiety is expected in pre-operative patients, the incidence of pre- operative anxiety is reported to range from 11-80% among patients. Preoperative anxiety is a challenging concept in the preoperative care of patients. Most patients awaiting elective surgery experience anxiety and it is widely accepted as an expected response. If unrecognized, prolonged anxiety creates stress which may subsequently harm the patient and delay recovery.

 

When surgery is recommended to an individual, the proposed operation, regardless of its extent, is perceived by the patient to be a major procedure. Besides that, patients will think about the recovery state and operative effect for their daily living, and also a fear about death and dying.3

 

A variety of therapeutic approaches have been made to reducing the anxiety before the operation, like music therapy, meditation, or spiritual therapy. Spirituality approach can be used to reduce patient’s anxiety, especially when they are facing a medical-surgical procedure.

 

Role of Psycho Neurobics– Psycho-neurobics is a meditation technique for effective healing through complete involvement of mind, body and soul. It encapsulated the supporting aspects of Rajyoga and Mudra healing. As Aerobics is the exercises of pumping air into lungs, neurobics is the exercises of creating bio electrical impulses in neuro cells / neuro transmitters by various motor or mental activities; similarly Psycho Neurobics is the exercises of transferring Spiritual Energy in neuro cells by connecting Psyche (Mind) to the Supreme Source of Spiritual Energy (God). Spirituality makes one feel the quietness. When calm, stress hormones will be reduced, so that the impact of stress hormones on wound healing can be minimized.

 

Although meditation has been practiced for centuries, it is only recently that the effects of meditation have been studied more extensively within the scientific community. Modern science has acknowledged the role of psyche, thought and emotions in healthy and unhealthy response in the body. So the present study is designed to assess the effect of Psychoneurobics (Neurobic spa) on anxiety level of patients undergoing cataract surgery. As in clinical settings - in the preoperative phase - extensive questionnaires are not applicable. Therefore, it is important to have applicable screening instruments to assess preoperative anxiety. So Besides objectivity, reliability and validity, the applicability is essential which refers to brevity, clinical relevance, patients’ acceptance as well as a fast and simple analysis format.


 
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