Clinical Trials Directory

Trials / Unknown

UnknownNCT05195606

The Effect of Auditory and Tactile Stimuli in Traumatic Coma

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Akdeniz University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERAuditory stimulusAuditory stimulus will be applied to the patients in intervention group A. For the auditory stimulus, the sound recording of the relatives of the patients will be taken and the patients will be listened to with headphones.
OTHERTactile stimulusTactile stimulus will be applied to the patients in the intervention group B. The tactile stimulus will be performed by the researcher with a foot massage to be applied to the patient.

Timeline

Start date
2024-06-15
Primary completion
2024-10-30
Completion
2024-12-30
First posted
2022-01-19
Last updated
2024-01-30

Source: ClinicalTrials.gov record NCT05195606. Inclusion in this directory is not an endorsement.