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CompletedNCT06329934Updated Mar 26, 2024

Refined Nursing in Rehabilitation Training

An interventional study of Establishment of a hierarchical monitoring and management team and Assessment of pressure injury in Brain Injuries, sponsored by Xinxiang Central Hospital. Completed at 1 site in China. Open to participants aged 33 Years to 43 Years. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Xinxiang Central Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled May 2022, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
33 Years to 43 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Brain Injuries

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Keywords

  • Refined nursing
  • Coma
  • Rehabilitation training
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 96 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

This is the only study on the registry with Xinxiang Central Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
33 Years to 43 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    the intervention group

    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

  • Active comparator
    the control group

    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

  • BehavioralEstablishment of a hierarchical monitoring and management team

    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.

  • BehavioralAssessment of pressure injury

    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.

  • BehavioralCommunication

    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

  • BehavioralIntervention for pressure ulcer

    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.

  • BehavioralRehabilitation training

    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

  • Behavioralintroduction of the current patient's condition to family members

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

  • Behavioralmaintaining appropriate temperature and humidity in the ward

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

  • Behavioralcareful observation of vital signs in patients

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one day before the intervention

  2. 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

    Time frame: 2 months after rehabilitation treatment

  3. 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)

    Time frame: one day before the intervention

  4. 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)

    Time frame: 2 months after rehabilitation treatment

  5. 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)

    Time frame: one day before the intervention

  6. 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)

    Time frame: 2 months after rehabilitation treatment

  7. 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

    Time frame: one day before the intervention

  8. 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

    Time frame: 2 months after rehabilitation treatment

  9. incidence of adverse reactions

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

    Time frame: one day before the intervention

  10. incidence of adverse reactions

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

    Time frame: 2 months after rehabilitation treatment

07

Study locations

1 site
  • Effect of Refined Nursing in Rehabilitation Training for Patients with Brain Injury During the Recovery Period: An Observational Study
    Xinxiang, Henan 453000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06329934
Lead sponsor
Xinxiang Central Hospital
Responsible party
Sponsor
First posted
Mar 26, 2024
Start date
May 1, 2022
Primary completion
May 31, 2023
Completion
Jan 1, 2024
Last update
Mar 26, 2024

Study contacts

Jie Yang
principal investigator · Xinxiang Central Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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