| CTRI Number |
CTRI/2026/01/102313 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FIGURINE BASED SIMULATION COMBINED WITH SENSORY INTEGRATION TECHNIQUES ON MENSTRUAL HYGIENE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Teaching Using Models and Sensory-Based Activities on Menstrual Hygiene Management in Individuals with Autism Spectrum Disorder |
|
Scientific Title of Study
|
IMPACT OF FIGURINE BASED SIMULATION COMBINED WITH SENSORY INTEGRATION TECHNIQUES ON MENSTRUAL HYGIENE AMONG CLIENTS WITH AUTISM SPECTRUM DISORDER. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S AKSHAYA NAVANEETHA |
| Designation |
UG STUDENT |
| Affiliation |
CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY , KELAMBAKKAM |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
6380800761 |
| Fax |
|
| Email |
akshaya25042003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhuvaneshwari S |
| Designation |
Assistance professor |
| Affiliation |
CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY , KELAMBAKKAM |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhuvaneshwari S |
| Designation |
Assistance professor |
| Affiliation |
CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY , KELAMBAKKAM |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9840016032 |
| Fax |
|
| Email |
bhuvaneshwaris@care.edu.in |
|
|
Source of Monetary or Material Support
|
| OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103 |
|
|
Primary Sponsor
|
| Name |
S AKSHAYA NAVANEETHA |
| Address |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103 |
| 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 |
| S Akshaya Navaneetha |
CHETTINAD GENERAL HOSPITAL |
OT Pediatric Division Ward No 24 Department of Occupational Therapy Chettinad General Hospital Chettinad Health City Rajiv Gandhi Salai OMR Kelambakkam Chennai Tamil Nadu India 603103
Kancheepuram
TAMIL NADU |
6380800761
akshaya25042003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research |
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 |
| Comparator Agent |
1.GOAL ATTAINMENT SCALE
2.BURDEN SCALE FOR FAMILY CAREGIVERS (BSFC)
|
The effect of the intervention will be assessed by comparing the results of the pre test collected in the beginning and post test after completing 4 week intervention period. |
| Intervention |
Figurine based simulation combined with sensory intergration |
Before enrolling each child in the study, informed consent will be obtained from their patients/guardian, along with assent from the participants, using consent forms approved by the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). A total of 50 individuals, aged 10 to 17 years and diagnosed with autism spectrum disorder will be recruited from the Occupational Therapy Department at Chettinad Hospital and Clinics in the Chengalpattu District. Eligibility will be confirmed through initial screening using the DSM-5. After obtaining consent and confirming inclusion criteria, participants will be randomly assigned into two groups: an intervention group (n = 25) and a control group (n = 25). Pre- intervention assessment of the independency will be conducted using the Goal attainment scale and burden scale for family caregivers .The experimental group will receive the figurine based simulation combined with sensory integration program, while the Control Group will not receive any intervention by researcher during this time. Eg: Each session will last 45 minutes, 3 days per week, for 4 weeks. After the 4 weeks intervention period, the independency will be reassessed using the same tools: Goal attainment scale and burden scale for family caregivers . Pre- and post-intervention scores will be statistically analyzed to evaluate the effectiveness of the intervention. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
Individual diagnosed with Autism spectrum disorder based on DSM-5 with IQ score above 80. Age group from 10 to 17years who have achieved their menstruation
No history of any other disabilities
|
|
| ExclusionCriteria |
| Details |
Other diagnoses or co-existing diagnoses with attention deficit hyperactive disorder , Cerebral palsy, intellectual disability , learning disability or other neurological disorders.
IQ level below 80
Age group of those who have not achieved their menstruation in the age group 10 to 17 years.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study Outcome will be measured using
GOAL ATTAINMENT SCALE
BURDEN SCALE FOR FAMILY CAREGIVERS (BSFC)
|
Menstrual hygiene will be assessed using the GOAL ATTAINMENT SCALE and caregiver burden will be assessed using BURDEN SCALE FOR FAMILY CAREGIVERS (BSFC) at baseline (pre-intervention), and reassessed after completion of four weeks of figurine based simulation combined with sensory intergration techniques based occupational therapy intervention (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| 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
|
This study is a randomized, parallel group , active contolled trial evaluating the impact of figurine based simulation combined with sensory intergration techniques on menstrual hygiene among clients with autism spectrum disorder. This study is a hospital-based randomized controlled interventional trial designed to evaluate the effectiveness of figurine-based simulation combined with sensory integration techniques on independence levels among children and adolescents with Autism Spectrum Disorder (ASD), as well as the burden experienced by their family caregivers. A total of 50 participants aged 10 to 17 years, diagnosed with Autism Spectrum Disorder based on DSM-5 criteria, will be recruited from the Department of Occupational Therapy, Chettinad Hospital and Clinics, Chengalpattu District. Written informed consent will be obtained from parents or legal guardians, along with assent from the participants, prior to enrollment. Ethical approval for the study has been obtained from the Institutional Review Board of Chettinad University Hospital (CHRI, CARE). Eligible participants will be randomly allocated into two groups: an intervention group (n = 25) and a control group (n = 25). Baseline assessment of independence and caregiver burden will be conducted using the Goal Attainment Scale and the Burden Scale for Family Caregivers. The intervention group will receive a figurine-based simulation program combined with sensory integration techniques, delivered for 45 minutes per session, three days per week, over a period of four weeks. The control group will receive no researcher-led intervention during the same period. At the end of the four-week intervention period, post-intervention assessments will be carried out using the same outcome measures. Pre- and post-intervention scores will be statistically analyzed to determine the effectiveness of the intervention in improving independence among individuals with ASD and reducing caregiver burden. |