Prospective assessment of auditory and cognitive performance in children undergoing ear surgeries: A comparative study
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:
-
P.T.A
-
Speech Audiometry
-
Impedance
Patient and caregiver both sent to Voice clinic for:
- Multi-dimensional voice program analysis (MDVP)
Patient will be administered
-
Hindi mental state examination questionnaire (HMSE)11
-
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
- 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:
-
P.T.A
-
Speech Audiometry
-
Impedance
Patient and caregiver both sent to Voice clinic for:
- Multi-dimensional voice program analysis (MDVP)
Patient will be administered
-
Hindi mental state examination questionnaire (HMSE)11
-
Glasgow benefit inventory scale
Objective cognitive function tests - 1) Trail making
- Color Wood Stroop task
Will be given the form, be asked to fill it and bring on the day of operation
Caregivers Administered –
-
Caregiver’s burden questionnaire
-
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
Dr. Adwitiya Kashyap Jha
All India Institute of Medical Sciences, New Delhi
