Clinical trial NCT05308186: Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness
Official title: Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness, Hospitalized in a Prolonged Respiratory Department- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Consciousness
Keywords: disorders of consciousness
pain
prolonged respiratory failure
sensory stimulation
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Samson Assuta Ashdod Hospital
name: Bet Hadar- Medical rehabilitation and nursing center
First posted: 2022-04-01
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Stable vital and essential signs taken from a nurse report
* A score between 1-4 in Coma Near Coma scale.

Exclusion Criteria:

* Spinal cord injury
* Past neurological disorders
* Past psychiatric disorders
* Pressure ulcers
* Prolonged fever
* Cellulite in one limb or more
* Urine retention

Primary outcomes:
measure: Behavioral pain scale (BPS) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
measure: Modify Ashworth scale (MAS) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
measure: EEG brainwave change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
measure: Respiratory Rate (RR) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
measure: Tidal Volume (TV) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
measure: Peak Inspiratory Pressure (PIP) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
measure: Systolic Blood Pressure (SBP) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
measure: Diastolic Blood Pressure (DBP) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
measure: Heart Rate (HR) change
timeFrame: Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arm 1 twice daily for 14 days; Change from baseline measured during arm 2 twice daily for 14 days
Secondary outcomes:
Other outcomes:
measure: Screening tool Coma Near Coma (CNC) scale
timeFrame: This tool will be used once as a filter to participate in research one day prior to measuring the baseline
Locations:
city: Ashdod
country: Israel
facility: Bet Hadar- Medical rehabilitation and nursing center
Study officials:
affiliation: Tel Aviv University
name: Shely Farag Harpak, B.O.T
role: STUDY_CHAIR
affiliation: Bet Hadar- Medical rehabilitation and nursing center
name: Yoseph Mishal, Dr.
role: PRINCIPAL_INVESTIGATOR
References: