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CTRI Number  CTRI/2023/06/053641 [Registered on: 07/06/2023] Trial Registered Prospectively
Last Modified On: 22/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Hypno-anaesthesia]  
Study Design  Single Arm Study 
Public Title of Study   To see if using clinical hypnosis can help in reducing pain and anxiety in adults and children who need to get skin procedures done  
Scientific Title of Study   Assessing effect of addition of hypnoanaesthesia to existing anaesthetic techniques in reducing anxiety and pain in adults and children undergoing dermatosurgical procedures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Somesh Gupta 
Designation  Professor 
Affiliation  AIIMS, Delhi 
Address  Room 4064, Teaching block, All India Institute of Medical Sciences, Aurobindo Marg

Central
DELHI
110029
India 
Phone  01126593217  
Fax    
Email  someshgupta@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Somesh Gupta 
Designation  Professor 
Affiliation  AIIMS, Delhi 
Address  Room 4064, Teaching block, All India institute of Medical Sciences, Aurobindo Marg

New Delhi
DELHI
110029
India 
Phone  01126593217  
Fax    
Email  someshgupta@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Somesh Gupta 
Designation  Professor 
Affiliation  AIIMS, Delhi 
Address  room 4064, Teaching block, AIIMS, Aurobindo Marg

New Delhi
DELHI
110029
India 
Phone  01126593217  
Fax    
Email  someshgupta@aiims.edu  
 
Source of Monetary or Material Support  
AIIMS, delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Delhi 
Address  Aurobindo marg Delhi 110029 
Type of Sponsor  Government medical college 
 
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 
Somesh Gupta  AIIMS,Delhi  Room A- 330, (Dermatology), New RAK OPD, AIIMS, Aurobindo Marg, Dlehi
Central
DELHI 		 01126593217

someshgupta@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, AIIMS, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hypno-anaesthesia  The patient is allowed to be comfortable, breathing awareness/ progressive muscle relaxation is used to get them to relax. Children are then given magic glove technique suggestions and adults are guided into a formal trance. Other local/ topical anesthesia is used as usual. Total duration is same as duration of procedure, 5-10 minutes 
Comparator Agent  Not applicable  not applicable 
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Adults or children >7 years of age undergoing procedures in the Dermatology Operation theatre complex.
2. Can understand English or Hindi well
3. Can follow verbal suggestions for modulating breathing rate, contract or relax muscles
4. Suggestible, as assessed by age-appropriate tests arm levitation or hand-clasp test (for adults) and magic-glove technique for children.
5. Patients agreeing to have their vitals monitored before, during and at end of procedure.
 
 
ExclusionCriteria 
Details  Patients with an inability to follow verbal instructions
(2) Patients/ guardians not giving consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain scores (VAS)
 		 before and after procedure 
 
Secondary Outcome  
Outcome  TimePoints 
subjective anxiety assessmet
Blood pressure and Heart rate monitoring before, during and after procedure 		 before and after procedure 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/06/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Hypnotherapy or trance-induction is a well-documented technique of intentionally inducing an altered conscious state where increased acceptability of verbal suggestions has been noted, along with a profound reduction of stress and anxiety. This can be used to alter perception of sensations including pain. This can be helpful for reduction of anxiety, as well as the perception of the needle prick, burning sensation of local anaesthetic agent, and residual sensations despite use of local anaesthetic agent. It has been used by small groups of surgeons, since 1946, by itself and as an adjunct for a host of surgical procedures including those otherwise requiring general anesthesia. Post-hypnotic suggestions can be used to have effects which continue after the trance and can be used to modify perception of post-operative pain. 
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