The Effect of Auditory and Tactile Stimuli in Traumatic Coma

Akdeniz University

Status: Not yet enrolling

Conditions: Head Trauma; Traumatic Coma; Nursing Caries

Treatments: Other: Auditory stimulus; Other: Tactile stimulus

Study type: Interventional

Funder types: Other

Identifiers

NCT05195606

KAEK-724

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Control group

No Intervention group

Description:

There is no standard sensory stimulation program for comatose patients with head trauma in the hospitals where the research will be conducted. Therefore, the control group will receive routine practice.

Auditory stimulus (Intervention A)

Experimental group

Description:

Auditory stimulus for patients in this group

Treatment:

Other: Auditory stimulus

Tactile stimulus (Intervention B)

Experimental group

Description:

Tactile stimulus for patients in this group

Treatment:

Other: Tactile stimulus