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NCT Number: NCT06329934

Refined Nursing in Rehabilitation Training

This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Craniocerebral Trauma Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Unconsciousness Wounds and Injuries

Age range

33 year–43 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Effect of Refined Nursing in Rehabilitation Training for Patients with Brain Injury During the Recovery Period: An Observational Study

Xinxiang, Henan, 453000, China

About this study

This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. The subjects of the study were 96 patients with severe traumatic brain injury (TBI). According to the order of visits, there were 48 patients in the study group and the control group, respectively.Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with severe TBI through imaging examinations such as head CT and magnetic resonance imaging
  • patients with surgical indications
  • patients with Glasgow Coma Scale (GCS) ≤8 points
  • patients with complete clinical data
  • patients with written informed consent provided by family members

Exclusion criteria

  • patients with organic lesions of major organs such as liver and kidney
  • patients with contraindications for surgery
  • patients with primary diseases such as cerebral hemorrhage and cerebral infarction
  • patients with combined or multiple injuries
  • patients with respiratory failure
  • patients whose family members had cognitive impairment or abnormal mental behaviors

Treatment and study plan

Establishment of a hierarchical monitoring and management team

Behavioral

To be specific, the head nurse served as the team leader to conduct comprehensive macro supervision; moreover, there were 3 responsible team leaders and 6 responsible nurses, all of whom had rich clinical nursing experience and solid theoretical knowledge of pressure injury. Consequently, a joint-action mechanism of the head nurse - responsible team leader - responsible nurses was developed to facilitate the unification of the training of nursing content, precautions, etc.

Assessment of pressure injury

Behavioral

Based on the postoperative coma of patients, the Braden assessment scale was applied to effectively evaluate patients from six dimensions of sensory perception, moisture, activity mode, mobility, nutrition, friction, and shear. The total score was 23 points. Patients scoring 13~14 points were evaluated by Braden once per week; and those scoring ≤12 points were evaluated at a frequency of 3d/ time.

Communication

Behavioral

Through intensive face-to-face communication with family members, timely information on the surgical effect, mechanism of pressure injury, preventive measures, and clinical manifestations through intuitive methods such as PPT and video, family members were taught with basic knowledge of pressure injury, and guided to inform medical staff in a timely manner when patients had symptoms of pressure ulcer. Simultaneously, by case sharing and positive suggestions, family members were supported to alleviate their concerns and improve their coordination with treatment

Intervention for pressure ulcer

Behavioral

For patients with a Braden score of >14 points, attention should be paid to keeping skin dry and clean, regularly changing bed sheets and bedding (once per day). Patients with Braden score of 13-14 points should be provided with sponge mattresses, increased times of turning over once per 2 hours, and soft pillows or foam dressings at the site of occipital protuberance to relieve pressure and prevent pressure injury. For patients with Braden score ≤12 points, medical staff should repeatedly emphasize to their families the harm of pressure injury to postoperative recovery.

Rehabilitation Training

Behavioral

After regaining consciousness with stable vital signs, patients received rehabilitation training following the principle of association of activity and inertia in a regular order. Patients were guided to perform upper limb movements, joint flexion, lower limb flexion and extension, as well as daily training such as washing face, rinsing mouth, and dressing at a frequency of 3~4 times/d. Moreover, patients were advised to minimize violent behaviors such as laughing and talking loudly

introduction of the current patient's condition to family members

Behavioral

timely introduction of the current patient's condition to family members to alleviate their concerns

maintaining appropriate temperature and humidity in the ward

Behavioral

maintaining appropriate temperature (20 ℃~22 ℃) and humidity (60.0%~70.0%) in the ward

careful observation of vital signs in patients

Behavioral

careful observation of vital signs such as heart rate, blood oxygen saturation, and blood pressure in patients

Primary outcomes

  1. GCS scores

    Time frame: one day before the intervention

    The highest GCS score was 15 points, indicating clear consciousness; while patients with 13-15, 9-12, and ≤8 points were classified as mild, moderate consciousness disorder, and coma, respectively. Patients with lower scores might indicate more serious consciousness disorder

  2. GCS scores

    Time frame: 2 months after rehabilitation treatment

    The highest GCS score was 15 points, indicating clear consciousness; while patients with 13-15, 9-12, and ≤8 points were classified as mild, moderate consciousness disorder, and coma, respectively. Patients with lower scores might indicate more serious consciousness disorder

  3. cognitive function scores

    Time frame: one day before the intervention

    Cognitive function was evaluated using the Chinese version of the Neurobehavioral Cognitive Status Exam (NCSE) to assess the cognitive function of patients before and 2 months after rehabilitation treatment. This scale includes 10 items, i.e., spatial orientation (12 points), concentration (8 points), understandability (6 points), retelling (12 points), naming (8 points), spatial construction (6 points), memory (12 points), computing (4 points), similarity (8 points), and judgment (6 points)

  4. cognitive function scores

    Time frame: 2 months after rehabilitation treatment

    Cognitive function was evaluated using the Chinese version of the Neurobehavioral Cognitive Status Exam (NCSE) to assess the cognitive function of patients before and 2 months after rehabilitation treatment. This scale includes 10 items, i.e., spatial orientation (12 points), concentration (8 points), understandability (6 points), retelling (12 points), naming (8 points), spatial construction (6 points), memory (12 points), computing (4 points), similarity (8 points), and judgment (6 points)

  5. functional independence scores

    Time frame: one day before the intervention

    Functional Independence Measure (FIM), utilizing a 7-point ordinal scale, was employed to assess the functional independence of two groups of patients before and 2 months after rehabilitation treatment. FIM measures independent performance in self-care, sphincter control, mobility, locomotion, communication, social cognition, etc. The minimum score is 18 points, and the maximum score is 126 points (91 points for motor function and 35 points for cognitive function)

  6. functional independence scores

    Time frame: 2 months after rehabilitation treatment

    Functional Independence Measure (FIM), utilizing a 7-point ordinal scale, was employed to assess the functional independence of two groups of patients before and 2 months after rehabilitation treatment. FIM measures independent performance in self-care, sphincter control, mobility, locomotion, communication, social cognition, etc. The minimum score is 18 points, and the maximum score is 126 points (91 points for motor function and 35 points for cognitive function)

  7. Newcastle Satisfaction with Nursing Scale (NSNS)

    Time frame: one day before the intervention

    The Newcastle Satisfaction with Nursing Scale (NSNS) was used to survey patient's nursing satisfaction. This scale measures patient's satisfaction with nursing care from 19 items, including nurse work ability, communication attitude, psychological counseling, nursing support, safety management, etc. It uses a 1-5 point scoring system, with a maximum possible score of 19-95 points. A score of ≥77, 58~76, 39~57 and ≤38 points indicated very satisfied, satisfied, somewhat satisfied, and dissatisfied, respectively. Satisfaction rate= (Cases of very satisfied + satisfied + somewhat satisfied)÷total cases

  8. Newcastle Satisfaction with Nursing Scale (NSNS)

    Time frame: 2 months after rehabilitation treatment

    The Newcastle Satisfaction with Nursing Scale (NSNS) was used to survey patient's nursing satisfaction. This scale measures patient's satisfaction with nursing care from 19 items, including nurse work ability, communication attitude, psychological counseling, nursing support, safety management, etc. It uses a 1-5 point scoring system, with a maximum possible score of 19-95 points. A score of ≥77, 58~76, 39~57 and ≤38 points indicated very satisfied, satisfied, somewhat satisfied, and dissatisfied, respectively. Satisfaction rate= (Cases of very satisfied + satisfied + somewhat satisfied)÷total cases

  9. incidence of adverse reactions

    Time frame: one day before the intervention

    Incidence (%)=Number of patients with complications/48×100%

  10. incidence of adverse reactions

    Time frame: 2 months after rehabilitation treatment

    Incidence (%)=Number of patients with complications/48×100%

Sponsors and collaborators

Lead sponsor

Xinxiang Central Hospital

Other

Registry information

Official study title

Effect of Refined Nursing in Rehabilitation Training for Patients With Brain Injury During the Recovery Period: An Observational Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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