| CTRI Number |
CTRI/2025/06/088781 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing reduction of anxiety in children with neurological disorder by sensory therapy and bubble therapy |
|
Scientific Title of Study
|
Efficacy of sensory immersion therapy and involvement therapy in reduction of state
anxiety during oral examination in children
with autism spectrum disorder - a 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 Meghana T |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 10 Department of Pediatric and preventive dentistry
KVG Dental College and Hospital
Kurunjibhag Sullia
Dakshina Kannada
Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7348925792 |
| Fax |
|
| Email |
meghanat1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha N S |
| Designation |
Professor and HOD |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 10 Department of Pediatric and preventive dentistry
KVG Dental College and Hospital
Kurunjibhag Sullia
Dakshina Kannada
Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448215834 |
| Fax |
|
| Email |
drsavithaks123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savitha N S |
| Designation |
Professor and HOD |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 10 Department of Pediatric and preventive dentistry
KVG Dental College and Hospital
Kurunjibhag Sullia
Dakshina Kannada
Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448215834 |
| Fax |
|
| Email |
drsavithaks123@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Meghana T |
| Address |
Room number 10 Department of Pediatric and Preventive dentistry
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada
Karnataka India Pincode 574327 |
| 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 Meghana T |
Special school based |
Special school
Dakshina Kannada
Karnataka
India
Dakshina Kannada
KARNATAKA |
7348925792
meghanat1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KVG Dental College and Hospital |
Approved |
| KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Involvement therapy |
The child will be given
commercially available bubble
breath solution and asked to
blow bubbles for 15 minutes. They will be encouraged to blow bigger bubbles and exhale
slowly. Following, An oral examination will be done using a mouth mirror and probe. Then, oral findings will be documented based on observations made during
oral examinations. Heart rate and anxiety will be recorded using respective tools, after the intervention. The total duration will be of 20 minutes. |
| Comparator Agent |
Sensory immersion therapy |
Clinical set-up will be customized with aromatherapy using diffuser, dimming lights and soothing music will be played. Slow moving visual colour effects will be projected on ceiling for 15 minutes. Then the child will be interacted
with preferred touch. Following, an oral examination will be done using a mouth mirror and probe. Then, oral findings will be documented based on observations made during oral examinations. Heart rate and anxiety will be recorded using respective tools. The total duration will be of 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 7-11 with a history of Level – 1 Autism Spectrum Disorder (ASD) in first dental visit.
2. Children who are capable of understanding with short, clear, and simple instructions. |
|
| ExclusionCriteria |
| Details |
1. Children whose parents decline to give consent.
2. Children with colds, asthma and respiratory diseases.
3. Children with visual and hearing difficulties.
4. Children who are allergic to any of the essential oils that have been used in this study.
5. Aggressive and uncooperative children.
6. Epileptic children |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the outcomes of sensory immersion therapy with involvement therapy in state anxiety reduction of children with ASD Level – 1. |
Baseline, after 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the baseline of state anxiety levels in children with ASD Level – 1.
2. To assess the efficacy of sensory immersion therapy on reduction of state anxiety levels in children
with ASD Level – 1.
3. To assess the efficacy of involvement therapy on reduction of state anxiety levels in children with ASD
Level – 1. |
Baseline, after 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/06/2025 |
| 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="6"
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
|
Autism is a complex neurodevelopment disarray described as a behavioral syndrome, consisting of
marked impairment in social interaction and communication skills and sensorimotor problems combined
with stereotyped and restricted behaviour. Children with autism spectrum disorder (ASD) experience
higher levels of anxiety in comparison to both neurotypical children and those with externalizing issues.
This increased anxiety tends to escalate as they grow older, underscoring its distinctive characteristic
within this particular population. ASD usually becomes apparent by the age of 3 and is diagnosed through criteria specified in the DSM,
which encompass limitations in social interaction and communication. Recognized characteristics in
autistic individuals, such as significant challenges in utilizing various non-verbal communication
methods, difficulty in forming social connections and sharing interests and experiences, delayed or absent
language development, and rigid adherence to routines, often accompanied by sensory sensitivities,
intellectual disabilities, or epilepsy, can impede both professional and home dental care. Thus, individuals
with ASD are more prone to oral health problems. In chairside Pediatric practice, common challenges encountered with these children include a reluctance
to seek attention, avoidance of eye contact, episodes of temper tantrums, and heightened reactivity to
sensory stimuli like sound, light, or pain. These factors can exacerbate difficulties in behaviour
management and potentially lead to avoidance of future dental appointments. Providing dental treatment for ASD children presents challenges due to unfamiliar stimuli and
environments, often resulting in uncooperative behaviours. Dental anxiety further complicates oral care,
ultimately affecting oral health. Effective oral behaviour management in Pediatric dentistry should
encompass personalized strategies and precise communication to enhance the success rate of oral care for
children with autism. Children with ASD often face difficulties in sensory processing, with studies suggesting that as many as
95% of them are sensitive to loud noises, changes in textures, bright light, or any other sudden shifts in
their environment. These sensory issues can affect their ability to engage with the world and may conduce
feelings of anxiety. Research by Atari et al. suggests that incorporating sensory interventions can help
reduce anxiety and improve overall well-being in these children. Motor difficulties in children with ASD arise during early childhood, often followed by deficits in social
communication, and generally increases over time, hindering opportunities for social interaction. Leary
and Hill suggested that motor skill plays a key role in communication and social interaction. Therefore, improving motor abilities in ASD children may leads to positive effects on their participation in physical
activities, thus opening significant pathway for social interaction. Hence, there is a need to tailor strategies to fit their likes and dislikes and to accommodate their behavioral
limitations. This makes behavior management easier while also allowing us to instill a positive attitude
towards dentistry. Therefore, in this study sensory and motor interventions will be implemented to reduce
anxiety and enhance overall well-being.
Thus, the purpose of this study is to evaluate the efficacy of sensory immersion therapy with involvement
therapy in reducing state dental anxiety among children with ASD Level – 1 |