| CTRI Number |
CTRI/2024/01/061696 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hypnoanaesthesia] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessing effect of addition of hypnoanaesthesia to existing anaesthetic techniques in
reducing anxiety and pain in children undergoing minor dermatosurgical procedures
|
|
Scientific Title of Study
|
A randomized controlled trial to assess the effect of adding hypnoanaesthesia to existing standard infiltration anaesthetic technique in reducing pain and anxiety in children undergoing minor dermatosurgical procedures, as compared to standard infiltration anaesthetic technique alone
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Yadav |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no. 4070, Department of Dermatology and Venereology, 4th floor, Old Teaching Block, AIIMS, New Delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
7976649004 |
| Fax |
|
| Email |
www.yspriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanika Sahni |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Dermatology and Venereology, 4th floor, Academic block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
01126594935 |
| Fax |
|
| Email |
kanu.sah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanika Sahni |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Dermatology and Venereology, 4th floor, Academic block, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
01126594935 |
| Fax |
|
| Email |
kanu.sah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology and Venereology, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 Priya Yadav |
All India Institute of Medical Sciences, New Delhi |
Room no 330, 3rd Floor, Department of Dermatology and Venereology, New Rajkumari Amrit Kaur OPD, AIIMS, New Delhi, India
New Delhi
DELHI |
7976649004
www.yspriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypnoanaesthesia |
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 aanesthesia. 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.
Magic glove technique will be used to deliver hypnoanesthesia and it will be performed once before the procedure |
| Comparator Agent |
Standard infiltartion anaesthesia |
Injection of local anaesthetic agent without hypnoanaesthesia |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1. Children 6 to 13 years of age undergoing minor procedures in the Dermatology Minor Operation theatre complex.
2. Can understand English or Hindi well
3. Can follow verbal suggestions for modulating breathing rate, contracting or relaxing muscles.
4. Patients agreeing to have their vitals monitored before, during and at end of procedure.
|
|
| ExclusionCriteria |
| Details |
Patients with an inability to follow verbal instructions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the percentage difference in mean VAS (Visual Analogue Scale) score of perceived pain of local anaesthetic injection between children receiving additional hypnoanaesthesia in combination with standard infiltration anaesthetic technique versus those receiving standard infiltration anaesthetic technique alone during minor dermatosurgical procedures |
Just after the injection of local anaesthetic agent |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the percentage difference in mean VAS score of perceived pain |
During & after the surgery |
| To assess the percentage reduction in VAS score of anxiety before & immediately after the hypnoanaesthesia in the intervention arm. |
Before & immediately after the hypnoanaesthesia |
| To evaluate the changes in respiratory rate, heart rate & blood pressure before & immediately after the administration of hypnoanaesthesia. |
before & immediately after the administration of hypnoanaesthesia |
| To assess the percentage difference in mean VAS score of post-operative pain at the end of 1 week between the control & intervention group |
Day 7 |
| To assess the percentage difference in mean VAS score of anxiety in parents during the surgical procedure of their child |
During the surgical 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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 aanesthesia. 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. |