Refined Nursing in Rehabilitation Training

NCT06329934 | Completed

• 1 other identifier: XXZY-003
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injuries

Keywords

Refined nursing; Coma; Rehabilitation training

Outcome Measures

Primary Outcomes (10)

• GCS scores

  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

  one day before the intervention

• GCS scores

  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 months after rehabilitation treatment

• cognitive function scores

  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)

  one day before the intervention

• cognitive function scores

  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)

  2 months after rehabilitation treatment

• functional independence scores

  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)

  one day before the intervention

• functional independence scores

  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)

  2 months after rehabilitation treatment

• Newcastle Satisfaction with Nursing Scale (NSNS)

  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

  one day before the intervention

• Newcastle Satisfaction with Nursing Scale (NSNS)

  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

  2 months after rehabilitation treatment

• incidence of adverse reactions

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

  one day before the intervention

• incidence of adverse reactions

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

  2 months after rehabilitation treatment

Study Arms (2)

the intervention group

EXPERIMENTAL

Establishment of a hierarchical monitoring and management team, Assessment of pressure injury, Communication, Intervention for pressure ulcer, Rehabilitation training

Behavioral: Establishment of a hierarchical monitoring and management team; Behavioral: Assessment of pressure injury; Behavioral: Communication; Behavioral: Intervention for pressure ulcer; Behavioral: Rehabilitation training

the control group

ACTIVE COMPARATOR

timely introduction of the current patient's condition to family members to alleviate their concerns, maintaining appropriate temperature (20 ℃\~22 ℃) and humidity (60.0%\~70.0%) in the ward, careful observation of vital signs such as heart rate, blood oxygen saturation, and blood pressure in patients, rehabilitation training

Behavioral: Rehabilitation training; Behavioral: introduction of the current patient's condition to family members; Behavioral: maintaining appropriate temperature and humidity in the ward; Behavioral: careful observation of vital signs in patients

Interventions

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.

the intervention group

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.

the intervention group

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

the intervention group

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.

the intervention group

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

the control group; the intervention group

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

the control group

maintaining appropriate temperature and humidity in the ward BEHAVIORAL

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

the control group

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

the control group

Eligibility Criteria

• Age: 33 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinxiang Central Hospital: lead

Study Sites (1)

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

Xinxiang, Henan, 453000, China

Location

MeSH Terms

Conditions

Brain Injuries; Coma

Interventions

Methods; Humidity

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment, Controlled; Environment and Public Health

Study Officials

• Jie Yang

  Xinxiang Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: May 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: January 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2022-05

Locations

CN (1)