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

NCT05308186 | Completed DMC

• 1 other identifier: 0151-21-AAA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Keywords

disorders of consciousness; pain; prolonged respiratory failure; sensory stimulation

Outcome Measures

Primary Outcomes (9)

• Behavioral pain scale (BPS) change

  BPS evaluates three behavioral domains (facial expressions, movement of upper limbs, and compliance with ventilation) that are based on observation of the patient body's posture and his response to a nociceptive stimulation. Each subscale is scored from 1 (no response) to 4 (full response). Therefore, possible BPS scores range from 3 (no pain) to 12 (maximum pain).

  Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14

• Modify Ashworth scale (MAS) change

  MAS is used to measure the increase of muscle tone which is manifested by an increased resistance of joints to passive movement. The MAS measures on the following 6 level ordinal scale: 0 = no increased resistance; 1 = slightly increased resistance (catch followed by relaxation or minimal resistance at the end of the range of motion); 1+ = slightly increased resistance (catch followed by minimal resistance throughout less than half of the range of motion); 2 = clear resistance throughout most of the range of motion; 3 = strong resistance; passive movement is difficult; 4 = rigid flexion or extension.

  Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14

• EEG brainwave change

  EEG will be sampled using the Mind-Wave dry electrode system, with one frontal electrode and one reference electrode on the earlobe, at a sampling rate of 512Hz. Positioning of the electrode conforms with the goal of monitoring prefrontal activity, which may correlate with attention regardless of the site of lesion. The sampled data is transferred through a wireless connection to the computer, where the Brain Engagement Index (BEI) is processed in real-time every 10 seconds and presented by the BEI monitor.

  Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14

• Respiratory Rate (RR) change

  The set ventilatory rate is the minimum number of breaths delivered to the patient per minute. The actual rate may be higher than the set rate if the patient is initiating spontaneous breaths. Rate is also a determinant of ventilation and is adjusted in response to the patient's CO2 (carbon dioxide) levels. RR will be collected from the patient's respiratory machine.

  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

• Tidal Volume (TV) change

  Tidal volume (TV) is the volume of gas delivered to the patient with each breath. Tidal volume may also be expressed as TV. TV is only set for volume-controlled modes of ventilation and is usually 8-12cc/kg of body weight. TV will be collected from the patient's respiratory machine.

  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

• Peak Inspiratory Pressure (PIP) change

  Inspiratory pressure reflects global alveolar pressure and is monitored continuously. The maximum allowable PIP is set on the ventilator. If the PIP exceeds the set value, an alarm will sound, and gas delivery will halt until the next breath is triggered. The normal peak inspiratory pressure on a mechanically ventilated patient with normal lungs is approximately 20cm H2O (water). The maximum allowable peak pressure varies from patient to patient. The pulmonologists determine the safest pressure for each patient. PIP values should be trended in volume-controlled modes to detect changes in pulmonary compliance. PIP will be collected from the patient's respiratory machine.

  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

• Systolic Blood Pressure (SBP) change

  SBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Cross-sectional values for systolic blood pressure: norm 120-129, normal-high 130-139, and hypertension ≥140. SBP will be collected using a monitoring equipment located in the departments.

  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

• Diastolic Blood Pressure (DBP) change

  DBP will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. Optimal diastolic blood pressure values \<80, with cross-sectional points to norm 80-84, normal-high 85-89, and hypertension ≥90. DBP will be collected using a monitoring equipment located in the departments.

  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

• Heart Rate (HR) change

  HR will be measured using monitoring equipment located in the departments. A device from Philips Medical Systems will be used. USA Model Suresigns VS2 +. The average pulse value is 60-80 beats per minute. HR will be collected using a monitoring equipment located in the departments.

  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

Other Outcomes (1)

• Screening tool Coma Near Coma (CNC) scale

  This tool will be used once as a filter to participate in research one day prior to measuring the baseline

Study Arms (2)

Auditory stimulation

EXPERIMENTAL

Exposing the patient to an audio-based stimulus.

Behavioral: Auditory stimulation

Auditory and tactile stimulations

EXPERIMENTAL

Combination of tactual and audio-based stimuli.

Behavioral: Auditory and tactile stimulations

Interventions

Auditory stimulation 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 stimulation

Auditory and tactile stimulations 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.

Auditory and tactile stimulations

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel Aviv University: lead
• Samson Assuta Ashdod Hospital: collaborator
• Bet Hadar- Medical rehabilitation and nursing center: collaborator

Study Sites (1)

Bet Hadar- Medical rehabilitation and nursing center

Ashdod, Israel

Location

Related Links

• Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients.
• Pain measurement techniques: Spotlight on mechanically ventilated patients.
• Comparison of Single and Combined Effects of Nature Sounds and Foot Sole Reflexology Massage on the Level of Consciousness in Traumatic Comatose Patients
• Suctioning: A review of current research recommendations
• The effects of massage and music on pain, anxiety and relaxation in burn patients: Randomized controlled clinical trial
• The effect of sensory stimulation provided by family on arterial blood oxygen saturation in critical care patients
• Inter-and intra-rater reliability of the Modified Ashworth Scale: A systematic review and meta-analysis
• Assessing pain in critically ill sedated patients by using a behavioral pain scale
• Plum and Posner's Diagnosis of Stupor and Coma
• Use of Music and Voice Stimulus on Patients With Disorders of Consciousness
• Accuracy of Critical Care Pain Observation Tool and Behavioral Pain Scale to assess pain in critically ill conscious and unconscious patients: Prospective, observational study
• Effects of the Sensory Stimulation Program on Recovery in Unconscious Patients With Traumatic Brain Injury
• EEG and autonomic responses to nociceptive stimulation in disorders of consciousness
• Psychometric Properties of the Coma Near-Coma Scale for Adults in Disordered States of Consciousness: A Rasch Analysis

MeSH Terms

Conditions

Consciousness Disorders; Pain

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Shely Farag Harpak, B.O.T

  Tel Aviv University

  STUDY CHAIR

• Yoseph Mishal, Dr.

  Bet Hadar- Medical rehabilitation and nursing center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The guardians and outcome assessor will not be made aware of the order of interventions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 1, 2022
• Study Start: April 10, 2022
• Primary Completion: September 18, 2022
• Study Completion: September 18, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)