| CTRI Number |
CTRI/2023/07/055706 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the effect of a planned exercise program and small breaks on perceived fatigue during surgery |
|
Scientific Title of Study
|
Study on the effect of a structured training program and micro breaks on workload amongst surgeons during open thyroidectomy and modified radical mastectomy: A Quasi-experimental study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 414, Fourth Floor Department of Surgical Disciplines
Surgery Block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9810534358 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 414, Fourth Floor Department of Surgical Disciplines
Surgery Block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9810534358 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suhani |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 414, Fourth Floor Department of Surgical Disciplines
Surgery Block
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9810534358 |
| Fax |
|
| Email |
drsuhani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Disciplines
Surgery Block
AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Surgical Disciplines
Surgery Block
AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hari Krishan Rathee |
AIIMS New Delhi |
Room No 204, second Floor Department of Surgical Disciplines
Surgery Block
AIIMS New Delhi
South
DELHI |
8699177674
ratheehari19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research All India Institute of Medical Sciences Ansari Nagar, New Delhi 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Perceived fatigue during surgery will be evaluated in healthy surgeons |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Structured training program and Microbreaks |
Structured muscle strengthening program and standardized micro breaks of 1.5 minutes after every 30 minutes during surgical procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Faculty members who have achieved their learning curve and have performed at least 20 open thyroidectomy and 50 modified radical mastectomy and residents of department of surgical disciplines |
|
| ExclusionCriteria |
| Details |
Pre-existing established musculoskeletal disorders, non - consenting candidates and non – compliant with the prescribed intervention
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of a structured muscle strengthening program & intraoperative micro breaks on the perceived physical workload amongst surgeons while performing open thyroidectomy & modified radical mastectomy |
During & post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the feasibility of using bio feedback for optimisation of muscle activity while performing open thyroidectomy & modified radical mastectomy and to study the musculoskeletal workload amongst the first and second assistant surgeons using NASA-TLX questionnaire.
|
During & post surgery |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/08/2023 |
| 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
|
Study is planned to see the effect of structured microbreaks and muscle strengthening exercise program on the workload perceived by surgeon during open thyroidectomy and modified radical mastectomy. |