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Effect of familial auditory stimulation on the autonomic function of patients after traumatic brain injury

Neurological and Respiratory Assessment in Individuals with Brain Injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10jvnfxg
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-02-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Brain Injuries

Interventions

A sample N = 15 patients will be allocated at random and randomized into three groups, two of which are intervention and a control group, in group 1 (N = 5) the ABACA protocol will be performed, group
E02.190.888.500

Sponsors

Universidade Federal do Triângulo Mineiro - UFTM.
Lead Sponsor
Universidade Federal do Triângulo Mineiro - UFTM.
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The study will include individuals affected by TBI considered severe, scoring from 3 to 8 points on the ECG and RAAS from 0 to -5, whether acute or subacute, from 24 hours to 14 days of admission to the clinical hospital of the Universidade Federal do Triângulo Mineiro, aged over 18 years.

Exclusion criteria

Exclusion criteria: The non-inclusion criteria are hemodynamically unstable individuals, with an increase in MAP above 110 or below 70 mmHg, individuals undergoing brain death protocol, history of hearing impairment, those cases in which it was not possible to define music or musical style preferred by the family and / or whose guardians do not agree with the study and do not sign the Informed Consent Form.

Design outcomes

Primary

MeasureTime frame
Expect a greater response from the autonomic nervous system after family auditory stimulation when compared to neutral auditory stimulation and the control group, to analyze the ANS response, an assessment of HRV performed using linear variables in the time domain, before and after musical intervention (SDNN - Standard deviation in all RR intervals, reflecting Sympathetic and Parasympathetic activity; RMSSD - Square root of the sum of the differences between RR intervals adjacent to the square, reflecting Parasympathetic activity; pNN50 - Percentage of the difference between adjacent RR intervals greater than 50ms reflecting parasympathetic activity); linear variables in the frequency domain (LF - Low-frequency, reflecting Sympathetic and Parasympathetic activity; HF - High-frequency, reflecting Parasympathetic modulation; LF / HF - Ratio between low and high frequency, reflecting the sympathetic-vagal balance); non-linear variables - Poincaré plot represented quantitatively by the SD1 indexes (represents the dispersion of the points perpendicular to the identity line related to the short duration of RR intervals), SD2 (represents the dispersion of the points along the identity line, represents records of long duration of RR intervals); SD1 / SD2 (ratio between short and long variations in RR intervals). Approximate Entropy (ApEn - approximate entropy, quantifies regularity and complexity of short time series); Detrended Fluctuation Analysis (DFA - Diluted fluctuation analysis, algorithm to quantify fluctuation properties without scale).

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Outcome results

None listed

Source: REBEC (via WHO ICTRP)