Ignite Creation Date:
2024-05-06 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05308186
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2022-02-24
Brief Title:
Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness
Sponsor:
Tel Aviv University
Organization:
Tel Aviv University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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 guardian15 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
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 guardian15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None