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A clinical trial to study the effectiveness of voice stimulus on the comatose patients.

A study to evaluate the effectiveness of voice stimulus on the level of consciousness, physiological parameters and behavioural response among the comatose patients admitted in tertiary hospital of Udupi district, Karnataka.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007368
Enrollment
20
Registered
2016-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Coma Health Condition 2: G978- Other intraoperative and postprocedural complications and disorders of nervous system

Interventions

Intervention1: Voice stimulus: The close relative of the patient was asked to write the message in a paper in her/his own language based on the script of the voice message provided by the researcher.

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactMrs Prima Jenevive Jyothi DSouza

Manipal College of Nursing Manipal

sulochana.k@manipal.edu9844995784

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026