| CTRI Number |
CTRI/2025/05/087202 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of Anxiety and Stress levels in pre and post Inhalational sedation and Nonpharmacological technique in children A Randomized Cross Over Clinical Trial. |
|
Scientific Title of Study
|
Comparison of Anxiety & Stress levels in pre & post Inhalational sedation & Non-pharmacological technique in children – A Randomized Cross Over Clinical Trial. |
| 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 Rashmi Chour |
| Designation |
Proffessor |
| Affiliation |
|
| Address |
Room number 9 Department of pedodontics PMNM dental college and hospital Bagalkot
Bagalkot
KARNATAKA
587103
India |
| Phone |
9845511526 |
| Fax |
|
| Email |
rashmi.dentist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Chour |
| Designation |
Proffessor |
| Affiliation |
P.M.N.M dental college & hospital |
| Address |
Room number 9 Department of pedodontics PMNM dental college and hospital Bagalkot
KARNATAKA
587103
India |
| Phone |
9845511526 |
| Fax |
|
| Email |
rashmi.dentist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Chour |
| Designation |
Proffessor |
| Affiliation |
P.M.N.M dental college & hospital |
| Address |
Room number 9 Department of pedodontics PMNM dental college and hospital Bagalkot
KARNATAKA
587103
India |
| Phone |
9845511526 |
| Fax |
|
| Email |
rashmi.dentist@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rashmi Chour |
| Address |
P.M.N.M. Dental College and Hospital Navanagar Bagalkote Pincode 587103 Karnataka India |
| 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 Rashmi Chour |
Room number 9 Department of pedodontics PMNM dental college and hospital |
Navanagar, Bagalkot
Bagalkot
KARNATAKA |
9845511526
rashmi.dentist@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of P.M.N.M.D.C.H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I & ASA II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulpectomy & Extractions of primary teeth done under Conscious sedation |
Pre- and post-anxiety levels were assessed using the Venham Clinical Anxiety & Cooperation Test and Venham Picture Test. Heart rate and oxygen saturation were monitored before and after the procedure. |
| Comparator Agent |
Pulpectomy & Extractions of primary teeth done under Non pharmacological techniques |
Pre- and post-anxiety levels were assessed using the Venham Clinical Anxiety & Cooperation Test and Venham Picture Test. Heart rate and oxygen saturation were monitored before and after the procedure. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Children falling under ASA I & ASA II category
Exhibiting moderate to severe anxiety.
Absence of mental retardation, no history drug therapy
Presence of at least two primary molars requiring the treatment.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease anxiety and stress level |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decreased anxiety & stress level in participants |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
• 40 children of age group 4-13 years, who reported to the department of pediatric and preventive dentistry were selected depending upon the inclusion criteria. Children were assigned into two equal groups (n=20). The principal investigator performed the randomization process before beginning the study Group A. (The conscious sedation group) 20 children were sedated by the rapid induction method by means of Nitrous oxide oxygen gas (inhalational) Group B. 20 children will receive the treatment by conventional behavior management techniques. Pre and post anxiety levels were recorded with venham clinical anxiety scale and heart rate and spo2 levels by connecting the monitor. |