A clinical trial to study the effectiveness of voice stimulus on the comatose patients.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- ComaHealth Condition 2: G978- Other intraoperative and postprocedural complications and disorders of nervous system
- Registration Number
- CTRI/2016/10/007368
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
The patients,
a)who were comatose (GCS 3-8).
b)in the age group of 20- 80 yrs.
c)who had normal hearing as screened by Auditory Brain Stem Response test.
Exclusion Criteria
The patients,
a)with relatives who were not willing to give consent for their patients to participate in the study and recording of the voice message.
b)who cannot understand Kannada, English, and Malayalam.
c)who are right handed, with left temporal hemorrhage.
d)with temporal bone fracture, ear bleed
e)who received any sedative drugs (eg. Inj. Midazolam)
f)with hearing impairment reported by family members
g)with any other co- morbidities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effectiveness of voice stimulus on the level of consciousness, physiological parameters and behavioural response of comatose patients.Timepoint: The physiological parameters and behavioural response were assessed every 1 min, 5 mins, 10 mins, 15 mins, 20 mins and 25 mins of starting the voice stimulus in each session.The level of consciousness was assessed using the Glasgow Coma Scale before and after the intervention for 3 times a day for 5 consecutive days.
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI