Clinical trial NCT05195606: The Effect of Auditory and Tactile Stimuli in Traumatic Coma
Official title: The Effect of Auditory and Tactile Stimulus on Consciousness, Oxygen Saturation, and Mean Arterial Pressure in Traumatic Coma Patients: A Randomized Controlled Single-Blind Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head Trauma
Traumatic Coma
Nursing Caries
Keywords: Head trauma
Nursing
Auditory stimulus
Tactile stimulus
Foot massage
Consciousness
Coma
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study focused on examining the effects of auditory and tactile stimuli to reduce sensory deprivation on consciousness, oxygen saturation and mean arterial pressure in traumatic coma patients.

Detailed description: Background: One of the most important problems experienced by patients treated in the intensive care unit due to traumatic coma is sensory deprivation.

Aim: In this study, it was aimed to examine the effects of auditory and tactile stimulus to be used in the prevention of sensory deprivation on consciousness, oxygen saturation and mean arterial pressure.

Study Design: The study was planned as a randomized controlled single-blind experiment with three groups. In the study, the patients in the Control group will be given a routine application, the patients in the Intervention A group will be given auditory stimuli, and the patients in the Intervention B group will be treated with tactile stimulus. Interventions will be administered once a day for seven days, for a total of seven times. The "block randomization method" was chosen as the randomization method. In this study, hospitals were taken as a block. An equal number of patients will be recruited from two hospitals and 15 patients will be distributed to three groups from each hospital using the "simple randomization method". 30 patients in each group and 90 patients in total will be included in the study.

Methods: The researcher applied to the patients hospitalized in the intensive care unit for 24-72 hours for seven days, once a day (seven times in total) between 10:00 and 15:00 (Intervention A: 10 minutes of audio recording will be played with headphones. Intervention B: 10 minutes) (5 minutes for one foot) foot massage will be applied. Glaskow Coma Score, oxygen saturation and Mean Arterial Pressure will be measured before and after each intervention (twice daily).

Eligibility criteria: Inclusion Criteria:

* Being treated in the intensive care unit for at least 24 hours due to traumatic coma,
* 18 years and older
* Relatives of those who agreed to participate in the study
* GCS score between 3-8 (GCS: 3-8 indicates coma)
* Without hearing impairment
* Having no authority for auditory stimulus
* No problem for foot massage (Lower extremity fracture, infection)

Exclusion Criteria:

* Who are under the age of 18
* Those whose relatives do not agree to participate in the research
* GKS score above 8

Primary outcomes:
measure: Glasgow Coma Scale (GCS)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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