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

Primary Purpose

Disorder of Consciousness

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Auditory stimulation
Auditory and tactile stimulations
Sponsored by
Tel Aviv University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Disorder of Consciousness focused on measuring disorders of consciousness, pain, prolonged respiratory failure, sensory stimulation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bet Hadar- Medical rehabilitation and nursing centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Auditory stimulation

Auditory and tactile stimulations

Arm Description

Exposing the patient to an audio-based stimulus.

Combination of tactual and audio-based stimuli.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2022
Last Updated
May 12, 2023
Sponsor
Tel Aviv University
Collaborators
Samson Assuta Ashdod Hospital, Bet Hadar- Medical rehabilitation and nursing center
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1. Study Identification

Unique Protocol Identification Number
NCT05308186
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
Collaborators
Samson Assuta Ashdod Hospital, Bet Hadar- Medical rehabilitation and nursing center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness
Keywords
disorders of consciousness, pain, prolonged respiratory failure, sensory stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Masking Description
The guardians and outcome assessor will not be made aware of the order of interventions.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auditory stimulation
Arm Type
Experimental
Arm Description
Exposing the patient to an audio-based stimulus.
Arm Title
Auditory and tactile stimulations
Arm Type
Experimental
Arm Description
Combination of tactual and audio-based stimuli.
Intervention Type
Behavioral
Intervention Name(s)
Auditory stimulation
Intervention Description
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
Intervention Name(s)
Auditory and tactile stimulations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavioral pain scale (BPS) change
Description
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).
Time Frame
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
Title
Modify Ashworth scale (MAS) change
Description
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.
Time Frame
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
Title
EEG brainwave change
Description
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.
Time Frame
Baseline is measured pre-intervention twice daily for 14 days. Change from baseline measured during arms 1 & 2 twice on days 1, 7, 14
Title
Respiratory Rate (RR) change
Description
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.
Time Frame
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
Title
Tidal Volume (TV) change
Description
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.
Time Frame
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
Title
Peak Inspiratory Pressure (PIP) change
Description
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.
Time Frame
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
Title
Systolic Blood Pressure (SBP) change
Description
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.
Time Frame
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
Title
Diastolic Blood Pressure (DBP) change
Description
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.
Time Frame
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
Title
Heart Rate (HR) change
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Screening tool Coma Near Coma (CNC) scale
Description
The CNC is a scale for patients with acquired brain injury, who function at very low levels of consciousness. The scale evaluates the occurrence of responses to visual, auditory, command following, threat response, olfactory, tactile, pain and vocalization. The CNC is both a quantitative assessment-with scores ranging from 4 (lowest level of consciousness) to 0 (highest level of consciousness)-and a qualitative assessment-with 5 levels comprising extreme coma (3.5-4), marked coma (2.9-3.49), moderate coma (2.01-2.89), near coma (0.9-2), no coma (0-0.89). Patients will be considered for the research between level 4-extreme coma to level 1-near coma.
Time Frame
This tool will be used once as a filter to participate in research one day prior to measuring the baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tami Bar Shalita Bar Shalita, Dr.
Phone
97236405447
Email
tbshalita@post.tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Itzik Burnett, M.A.
Email
itzikba@assuta.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shely Farag Harpak, B.O.T
Organizational Affiliation
Tel Aviv University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yoseph Mishal, Dr.
Organizational Affiliation
Bet Hadar- Medical rehabilitation and nursing center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bet Hadar- Medical rehabilitation and nursing center
City
Ashdod
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoseph Mishal, MD
First Name & Middle Initial & Last Name & Degree
Shelly Farag Harpak, BOT

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon personal request
Links:
URL
http://doi.org/10.1213/01.ANE.0000182331.68722.FF
Description
Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients.
URL
https://doi.org/10.2147/JPR.S151169
Description
Pain measurement techniques: Spotlight on mechanically ventilated patients.
URL
http://doi.org/10.1097/HNP.0000000000000326
Description
Comparison of Single and Combined Effects of Nature Sounds and Foot Sole Reflexology Massage on the Level of Consciousness in Traumatic Comatose Patients
URL
http://doi.org/10.1155/2017/9071568
Description
An EEG Tool for Monitoring Patient Engagement during Stroke Rehabilitation: A Feasibility Study.
URL
http://doi.org/10.1093/ptj/67.2.206
Description
Interrater reliability of a modified Ashworth scale of muscle spasticity
URL
http://doi.org/10.1016/S0964-3397(02)00004-6
Description
Suctioning: A review of current research recommendations
URL
http://doi.org/10.1016/j.burns.2017.01.011
Description
The effects of massage and music on pain, anxiety and relaxation in burn patients: Randomized controlled clinical trial
URL
http://www.ncbi.nlm.nih.gov/pubmed/25709692
Description
The effect of sensory stimulation provided by family on arterial blood oxygen saturation in critical care patients
URL
http://doi.org/10.23736/S1973-9087.17.04796-7
Description
Inter-and intra-rater reliability of the Modified Ashworth Scale: A systematic review and meta-analysis
URL
http://doi.org/10.1097/00003246-200112000-00004
Description
Assessing pain in critically ill sedated patients by using a behavioral pain scale
URL
https://books.google.co.il/books?hl=iw&lr=&id=AggSDAAAQBAJ&oi=fnd&pg=PR9&dq=Plum+and+Posner%E2%80%99s++diagnosis+of+stupor+and+coma&ots=Cq6tSgV5qV&sig=ETNN-3ALG2eMjP1L_LHmIon9Cg0&redir_esc=y#v=onepage&q=Plum%20and%20Posner%E2%80%99s%20%20diagnosis%20of%20stupor%20and%20coma&f=false
Description
Plum and Posner's Diagnosis of Stupor and Coma
URL
http://doi.org/10.1097/JNN.0b013e3182029778
Description
Use of Music and Voice Stimulus on Patients With Disorders of Consciousness
URL
http://doi.org/10.1186/s40560-016-0192-x
Description
Accuracy of Critical Care Pain Observation Tool and Behavioral Pain Scale to assess pain in critically ill conscious and unconscious patients: Prospective, observational study
URL
http://doi.org/10.3233/NRE-172229
Description
Physical therapy in patients with disorders of consciousness: Impact on spasticity and muscle contracture
URL
http://doi.org/10.1097/JNN.0b013e3181a23e94
Description
Effects of the Sensory Stimulation Program on Recovery in Unconscious Patients With Traumatic Brain Injury
URL
http://doi.org/10.1016/J.JOCN.2018.09.020
Description
EEG and autonomic responses to nociceptive stimulation in disorders of consciousness
URL
http://doi.org/10.1016/j.apmr.2020.10.119
Description
Psychometric Properties of the Coma Near-Coma Scale for Adults in Disordered States of Consciousness: A Rasch Analysis
URL
http://doi.org/10.1093/eurheartj/ehy339
Description
The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH)

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

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