| CTRI Number |
CTRI/2021/09/036961 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effects of yoga therapy on anxiety and pain in patients undergoing extraction of wisdom tooth |
|
Scientific Title of Study
|
Effects Of Pranayama On Anxiety And Perception Of Pain In Patients Undergoing Surgical Extraction Of Mandibular Impacted Third Molar |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raymond Joseph Periera |
| Designation |
Postgraduate Student |
| Affiliation |
Indira Gandhi Institute Of Dental Sciences, Pondicherry |
| Address |
Department of Oral and Maxillofacial Surgery,
Ground floor, Old building,
Indira Gandhi Institute Of Dental Sciences,
Pilliyarkupam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9972158300 |
| Fax |
|
| Email |
raymondjp814@gmaill.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRSathyanarayanan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Indira Gandhi Institute Of Dental Sciences, Pondicherry |
| Address |
Department of Oral and Maxillofacial Surgery,
Ground floor, Old building,
Indira Gandhi Institute Of Dental Sciences,
Pilliyarkupam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894027921 |
| Fax |
|
| Email |
adithyarajam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sathyanarayanan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Indira Gandhi Institute Of Dental Sciences, Pondicherry |
| Address |
Department of Oral and Maxillofacial Surgery,
Ground floor, Old building,
Indira Gandhi Institute Of Dental Sciences,
Pilliyarkupam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894027921 |
| Fax |
|
| Email |
adithyarajam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Dental Sciences, Pondicherry |
|
|
Primary Sponsor
|
| Name |
RAYMOND JOSEPH PERIERA |
| Address |
Department of Oral and Maxillofacial Surgery,
Ground floor, Old building,
Indira Gandhi Institute Of Dental Sciences,
Pilliyarkupam, Pondicherry |
| Type of Sponsor |
Other [Self] |
|
|
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 Raymond Joseph Periera |
Indira Gandhi Institute Of Dental Sciences, Pondicherry |
Department Of Oral and Maxillofacial Surgery,
Ground Floor , Old Building, Indira Gandhi Institute Of Dental Sciences, Pondicherry
Pondicherry
PONDICHERRY |
9972158300
raymondjp814@gmaill.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGIDS Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M270||Developmental disorders of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PRANAYAMAS(BREATHING EXERCISES) |
15 minutes of yoga practice (Sukha pranayama, Chandrabhedana pranayama , Brahmari pranayama ) will be done which will be preceeded and succeeded by quite sitting. |
| Comparator Agent |
SELF RELAXATION |
patients asked to perform their own Self relaxation techniques for 15 mins |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals willing to take part in the study.
2. Subjects who are advised for surgical extraction of mandibular third molar (mesioangluar).
|
|
| ExclusionCriteria |
| Details |
1. Having history of significant psychosis/ cognitive impairment.
2. Patient with acute illness or terminally ill patients.
3. Pregnant women and lactating mother.
4. Patient’s already practicing yoga.
5. Patient with prior history of traumatic dental experience.
6. Patient with history of systemic disease.
7. Patients under medication like antihypertensive, sedatives and hypnotics.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the effectiveness of treatment outcome by using conventional pranayama on anxiety and perception of pain in patients undergoing surgical extraction of mandibular third molar. |
15mins of pranayama |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety reduction and reduction in pain perception |
1 week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised control trial comparing the effects of pranayama on anxiety and perception of pain in undergoing surgical extraction of mandibular impacted third molar. The primary outcome is pranayama will help reduce anxiety of patients undergoing surgical extraction of mandibular impacted third molar thereby improving quality of life |