| CTRI Number |
CTRI/2019/04/018811 [Registered on: 26/04/2019] Trial Registered Prospectively |
| Last Modified On: |
25/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the use of clinical hypnosis in reducing pre operative anxiety in patients undergoing knee replacement surgeries. |
|
Scientific Title of Study
|
Hypnosis as a tool for reducing pre-operative anxiety in patients undergoing total knee replacement – a randomized case control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yamini Arora |
| Designation |
Senior Registrar |
| Affiliation |
Fortis Hospital,Mohali |
| Address |
Department of Anesthesiology
Fortis Hospital
Sector 62, Sahibzada Ajit Singh Nagar,
Punjab ,160062
Rupnagar
PUNJAB
160062
India |
| Phone |
9891094385 |
| Fax |
|
| Email |
yaminiaro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padma Puppala |
| Designation |
Additional Director |
| Affiliation |
Fortis Hospital,Mohali |
| Address |
Department of Anesthesiology
Fortis Hospital
Sector 62, Sahibzada Ajit Singh Nagar,
Punjab, 160062
Rupnagar
PUNJAB
160062
India |
| Phone |
8968899332 |
| Fax |
|
| Email |
puppalapadma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yamini Arora |
| Designation |
Senior Registrar |
| Affiliation |
Fortis Hospital,Mohali |
| Address |
Department of Anesthesiology
Fortis Hospital
Sector 62, Sahibzada Ajit Singh Nagar,
Punjab, 160062
Rupnagar
PUNJAB
160062
India |
| Phone |
9891094385 |
| Fax |
|
| Email |
yaminiaro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fortis Hospital
Sector 62,Sahibzada Ajit Singh Nagar
Punjab.160062 |
|
|
Primary Sponsor
|
| Name |
Yamini Arora |
| Address |
Senior Registrar
Department of Anesthesiology,
Fortis Hospital
Sector 62 , Sahibzada Ajit Singh Nagar,
Punjab 160062 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Fortis Hospital Mohali |
Sector 62 Sahibzada Ajit Singh Nagar
Punjab 160062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yamini Arora |
Fortis Hospital,Mohali |
Department of Anesthesiology
Fortis Hospital
Sector 62,sahibzada Ajit singh Nagar
Punjab,160062
Rupnagar
PUNJAB |
9891094385
yaminiaro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clinical Hypnosis |
Clinical hypnosis is a way of inducing a pleasant, voluntary state of relaxed attentive concentration, an altered state of consciousness, during which the conscious critical mind is relaxed, and is connected to the subconscious inner mind. In this comfortable state the senses are heightened, the inner mind is more receptive to acceptable, beneficial suggestions |
| Comparator Agent |
Standard of care |
Routine pre operative counseling by an anesthesiologist |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 30 to 75 years
2.Patients with ASA grade I & II
3.Body Mass Index( BMI) less than 40kg/m2
4.Able to understand and cooperate
5.Willing to participate
6.Patients scheduled for Knee Replacement under regional anesthesia.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA grade III and IV
3.Patients with history of opioid intake or/and substance abuse
4.Difficulty in hearing and following instruction.
5.Patients with history of disorder of cognition or psychiatric disorder
6.Patients done under general anesthesia
7.Use of epidural catheter.
8.Patients with BMI greater than 40 kg/m2
9.Patients having allergy to any drug used as a part of the protocol
10.Patients with past history of any surgery or use of hypnosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of pre-operative use of clinical hypnosis on pre-operative anxiety scores |
Anxiety levels on arrival to the pre operative area. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the pre-operative anxiety scores of the patients comprising the study group with those receiving the standard of care therapy
Compare the incidence of post-operative nausea and analgesic drug requirement between the two groups.
|
0 to 48 hours |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/04/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clinical hypnosis has been shown to reduce preoperative anxiety and improve postoperative pain scores in the patient undergoing both minor and major surgical procedures. Role of clinical hypnosis in the Indian population and Joint replacement patients, however, remains unevaluated. In this study, we wish to evaluate the efficacy of clinical hypnosis in reducing preoperative anxiety in patients undergoing knee replacement surgery. |