search
Back to results

The Effect of Auditory and Tactile Stimuli in Traumatic Coma

Primary Purpose

Head Trauma, Traumatic Coma, Nursing Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auditory stimulus
Tactile stimulus
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head Trauma focused on measuring Head trauma, Nursing, Auditory stimulus, Tactile stimulus, Foot massage, Consciousness, Coma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control group

    Auditory stimulus (Intervention A)

    Tactile stimulus (Intervention B)

    Arm 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 for patients in this group

    Tactile stimulus for patients in this group

    Outcomes

    Primary Outcome Measures

    Glasgow Coma Scale (GCS)
    GCS is a diagnostic tool that provides objective evaluation of the patient's eye-opening, verbal and motor response to stimuli. In the scale, the eye opening score is between 1-4, the verbal response is between 1-5, and the motor response is between 1-6, and the total score is between 3-15. The GCS score of the patient who did not respond to painful stimuli, could not open his eyes spontaneously, and had complete loss of muscular tone was three; The GCS score of the patient who is oriented, spontaneously opens his eyes and fulfills the orders is 15. It should be understood that the patient with a GCS score of less than eight is in a coma.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 29, 2021
    Last Updated
    July 19, 2023
    Sponsor
    Akdeniz University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05195606
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Akdeniz University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head Trauma, Traumatic Coma, Nursing Caries
    Keywords
    Head trauma, Nursing, Auditory stimulus, Tactile stimulus, Foot massage, Consciousness, Coma

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    In the application process, single blinding will be provided as the patients do not know which group they are included in.
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Auditory stimulus (Intervention A)
    Arm Type
    Experimental
    Arm Description
    Auditory stimulus for patients in this group
    Arm Title
    Tactile stimulus (Intervention B)
    Arm Type
    Experimental
    Arm Description
    Tactile stimulus for patients in this group
    Intervention Type
    Other
    Intervention Name(s)
    Auditory stimulus
    Intervention Description
    Auditory 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.
    Intervention Type
    Other
    Intervention Name(s)
    Tactile stimulus
    Intervention Description
    Tactile 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.
    Primary Outcome Measure Information:
    Title
    Glasgow Coma Scale (GCS)
    Description
    GCS is a diagnostic tool that provides objective evaluation of the patient's eye-opening, verbal and motor response to stimuli. In the scale, the eye opening score is between 1-4, the verbal response is between 1-5, and the motor response is between 1-6, and the total score is between 3-15. The GCS score of the patient who did not respond to painful stimuli, could not open his eyes spontaneously, and had complete loss of muscular tone was three; The GCS score of the patient who is oriented, spontaneously opens his eyes and fulfills the orders is 15. It should be understood that the patient with a GCS score of less than eight is in a coma.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Auditory and Tactile Stimuli in Traumatic Coma

    We'll reach out to this number within 24 hrs