| 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
|
|
|
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
|
|
|
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. |