| CTRI Number |
CTRI/2021/11/037751 [Registered on: 02/11/2021] Trial Registered Prospectively |
| Last Modified On: |
28/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effects of yoga therapy on anxiety in patients undergoing extraction of wisdom tooth |
|
Scientific Title of Study
|
Effect Of Pranayama On Psycho-Physiological Indicators Of Anxiety In Patients Of Impacted Lower Third Molar Extraction - A Randomised Control Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka G |
| 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 |
9841495619 |
| Fax |
|
| Email |
priyankaganesan0418@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sathyanarayanan |
| Designation |
Professor and HOD |
| 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 Priyanka G |
| 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 |
9841495619 |
| Fax |
|
| Email |
priyankaganesan0418@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Dental Sciences, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka G |
| 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 Priyanka G |
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES |
Department Of Oral and Maxillofacial Surgery, Ground Floor , Old Building, Indira Gandhi Institute Of Dental Sciences, Pondicherry
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
9841495619
priyankaganesan0418@gmail.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: M263||Anomalies of tooth position of fully erupted tooth or teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Self relaxtion |
frequency is 3 times,
durarion 5mins |
| Intervention |
yoga (Pranayama)
Sukha pranayama
Pranava pranayama
Chandranadi pranayama |
Frequency is 3 times
duration is 5 mins each pranayama |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 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
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the patients anxiety |
10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety reduction of patients |
1 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/11/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published after the study is completed |
|
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 |