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Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness

T

Tel Aviv University

Status

Completed

Conditions

Disorder of Consciousness

Treatments

Behavioral: Auditory and tactile stimulations
Behavioral: Auditory stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05308186
0151-21-AAA

Details and patient eligibility

About

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.

Full 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:

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:

Physiological signs (blood pressure, pulse and respiratory indices) post intervention will be lower. Degree of spasticity post intervention will be lower. Pain levels post intervention will be lower. 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. 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.

Enrollment

10 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 2 patient groups

Auditory stimulation
Experimental group
Description:
Exposing the patient to an audio-based stimulus.
Treatment:
Behavioral: Auditory stimulation
Auditory and tactile stimulations
Experimental group
Description:
Combination of tactual and audio-based stimuli.
Treatment:
Behavioral: Auditory and tactile stimulations

Trial contacts and locations

1

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Central trial contact

Tami Bar Shalita Bar Shalita, Dr.; Itzik Burnett, M.A.

Data sourced from clinicaltrials.gov

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