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临床试验/NCT05195606
NCT05195606Unknown不适用

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

Akdeniz University0 个研究点目标入组 90 人开始时间: 2024年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
主要终点
Glasgow Coma Scale (GCS)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

In the application process, single blinding will be provided as the patients do not know which group they are included in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

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

研究组 & 干预措施

Control group

No Intervention

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

Auditory stimulus for patients in this group

干预措施: Auditory stimulus (Other)

Tactile stimulus (Intervention B)

Experimental

Tactile stimulus for patients in this group

干预措施: Tactile stimulus (Other)

结局指标

主要结局

Glasgow Coma Scale (GCS)

时间窗: 1 week

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arş. Gör. Arzu TAT ÇATAL

Principal Investigator

Akdeniz University

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