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临床试验/CTRI/2024/09/074218
CTRI/2024/09/074218尚未招募不适用

Prospective assessment of auditory and cognitive performance in children undergoing ear surgeries: A comparative study

ALL INDIA INSTITUTE OF MEDICAL SCIENCES1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
1. P.T.A

研究概览

简要总结

Day of Evaluation and Admission:-

Patient taken up for:-

History

Examination - Ear examination and Tuning fork test

Patient sent to Audiologist for:

  1. P.T.A

  2. Speech Audiometry

  3. Impedance

Patient and caregiver both sent to Voice clinic for:

  1. Multi-dimensional voice program analysis (MDVP)

Patient will be administered

  1. Hindi mental state examination questionnaire (HMSE)11

  2. Glasgow benefit inventory scale

Objective cognitive function tests - 1) Trail making                                                     2) Color Wood Stroop task

Will be given the form, be asked to fill it and bring on the day of operation

Caregivers Administered – 1. Caregiver’s burden questionnaire

  1. Samples taken for Serum cortisol level

Day of Surgery

Collection of      – Audiological reports

– Questionnaire and task sheets

Postoperatively, all patients will be given intravenous/oral antibiotics, analgesics and antihistaminic for 14 days

Follow up advice will be given after 3 months to the patient as well as to the caregivers

3rd Month Post Surgery

Patient sent to Audiologist for:

  1. P.T.A

  2. Speech Audiometry

  3. Impedance

Patient and caregiver both sent to Voice clinic for:

  1. Multi-dimensional voice program analysis (MDVP)

Patient will be administered

  1. Hindi mental state examination questionnaire (HMSE)11

  2. Glasgow benefit inventory scale

Objective cognitive function tests - 1) Trail making

  1. Color Wood Stroop task

Will be given the form, be asked to fill it and bring on the day of operation

Caregivers Administered –

  1. Caregiver’s burden questionnaire

  2. Samples taken for Serum cortisol level

Total duration of intervention - 3 months

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
0.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Age less than 14 years
  • Patients undergoing select ear surgeries like Tympanoplasty, Mastoidectomy and Myringotomy with or without Grommet insertion between July 2024 to December 2026
  • Child is able to perform cognitive function tests.

排除标准

  • Patients with mixed hearing loss/sensory neural hearing loss (SNHL).
  • Complicated CSOM
  • Presence of neuro-psychological disorders
  • Revision surgery
  • Syndromic condition
  • Caretakers not giving consent.

结局指标

主要结局

1. P.T.A

时间窗: 3 months

2. Speech Audiometry

时间窗: 3 months

3. Impedance

时间窗: 3 months

次要结局

  • 1. Multi-dimensional voice program analysis (MDVP)(2. Hindi mental state examination questionnaire (HMSE)11)
  • 1. Caregiver’s burden questionnaire(2. Serum cortisol level)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Adwitiya Kashyap Jha

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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