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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2022-09-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Disorder of Consciousness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

The guardians and outcome assessor will not be made aware of the order of interventions.

Study Groups

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Auditory stimulation

Exposing the patient to an audio-based stimulus.

Group Type EXPERIMENTAL

Auditory stimulation

Intervention Type BEHAVIORAL

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.

Auditory and tactile stimulations

Combination of tactual and audio-based stimuli.

Group Type EXPERIMENTAL

Auditory and tactile stimulations

Intervention Type BEHAVIORAL

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.

Interventions

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Auditory stimulation

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.

Intervention Type BEHAVIORAL

Auditory and tactile stimulations

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No