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临床试验/CTRI/2026/01/102313
CTRI/2026/01/102313尚未招募2/3 期

IMPACT OF FIGURINE BASED SIMULATION COMBINED WITH SENSORY INTEGRATION TECHNIQUES ON MENSTRUAL HYGIENE AMONG CLIENTS WITH AUTISM SPECTRUM DISORDER.

S AKSHAYA NAVANEETHA1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月3日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
10.00 Year(s) 至 17.00 Year(s)(—)
性别
Female

入选标准

  • Individual diagnosed with Autism spectrum disorder based on DSM-5 with IQ score above
  • Age group from 10 to 17years who have achieved their menstruation No history of any other disabilities.

排除标准

  • 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.

研究者

发起方
S AKSHAYA NAVANEETHA
申办方类型
Other [SELF ]
责任方
Principal Investigator
主要研究者

S AKSHAYA NAVANEETHA

CHETTINAD SCHOOL OF OCCUPATIONAL THERAPY , KELAMBAKKAM

研究点 (1)

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