Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness
Condition: Disorder of Consciousness
MeSH terms: Consciousness Disorders
Study type: Interventional

Summary: 
      The aim of the presented study is to examine the effectiveness of sensory stimulation in
      reducing pain and stress of patients diagnosed with Disorder of consciousness.
    

Detailed description: 
      Background: Disorder of consciousness (DOC) is a medical state in which the person's ability
      to be aware of himself and his surroundings is impaired due to an acquired brain injury.
      Neuroimaging during nociceptive stimulation in patients with DOC shows an activation in the
      network affiliated with the affective dimension of pain, providing evidence that patients can
      feel pain without behavioral signs. While patients not experiencing DOC receive medical care
      for reducing pain derived from daily medical procedures, patients with DOC receiving these
      same medical procedures do not receive such care for pain alleviation. Sensory stimulation
      has been found as an effective intervention for the stabilization and improvement of
      physiological signs, yet its' effectiveness in reducing pain in patients with DOC has not
      been studied.

      Methods: Crossover experimental research will be conducted on one focus group without a
      control group, that includes recurring tests prior and after intervention. At the first stage
      of the research, the data will be collected twice a day, for fourteen days, once when the
      patient is in rest and once pre- and post-endotracheal suction. The second stage will include
      interventions based on two arms - auditory stimulation and a combination of auditory and
      tactile stimulations at the same time. Measures will be collected in days one, seven and
      fourteen in each arm. All measures will be applied pre- and post-endotracheal suction which
      will be conducted after the intervention period, as specified above, and during a patient
      rest period before and after intervention. Both interventions will be conducted for ten
      minutes each, twice daily, for fourteen days.

      Population: After receiving consent to participate in the study from a guardian,15 adults
      aged 30-75, diagnosed with DOC, hospitalized in prolonged respiratory department will
      participate.

      Tools: Physiological signs, behavioral pain scale, Modify Ashworth Scale, Brain Engagement
      Index.

      Expected Results:

        1. Statistical significance will be found between measurements prior to interventions
           (control) and after interventions, both during rest (clinical pain) and during medical
           procedures, in the following measures:

             1. Physiological signs (blood pressure, pulse and respiratory indices) post
                intervention will be lower.

             2. Degree of spasticity post intervention will be lower.

             3. Pain levels post intervention will be lower.

        2. Statistical significance will be found in the levels of attention during interventions
           (sensory stimulations) in comparison to before the interventions (control), where the
           former will be higher in comparison to the latter.

        3. Statistical significance will be found in the efficiency of multi-sensory stimulations
           in comparison to a single sensory stimulation, where the former will show lower
           physiological signs, spasticity, and levels of pain during rest and medical procedures.

      Findings may improve the quality of life in patients with respiratory distress, diagnosed
      with DOC, providing additional treatment options for pain management other than medications.
    

Intervention name(s): Auditory stimulation; Auditory and tactile stimulations
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The patient will be exposed to music that he used to enjoy (from the family's or guardian's report) through headphones. In case no report is given, nature (brook) sounds will be streamed.; The patient will be exposed to music that he used to enjoy (from the family's or guardian's report, otherwise nature (brook) music will be streamed) through headphones combined with deep tissue massage will be given on the upper limbs.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: disorders of consciousness; pain; prolonged respiratory failure; sensory stimulation