Brain InjuriesNCT06329934
Refined Nursing in Rehabilitation Training
A study testing Establishment of a hierarchical monitoring and management team, Assessment of pressure injury and Communication in people with Brain Injuries, run by Xinxiang Central Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 33 to 43 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Establishment of a hierarchical monitoring and management team, Assessment of pressure injury and Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 43 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Effect of Refined Nursing in Rehabilitation Training for Patients with Brain Injury During the Recovery Period: An Observational Study
Xinxiang, Henan, 453000
About this study
Official title: Effect of Refined Nursing in Rehabilitation Training for Patients With Brain Injury During the Recovery Period: An Observational Study
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.
- Conditions
- Brain Injuries
- Being tested
- Establishment of a hierarchical monitoring and management team, Assessment of pressure injury, Communication, Intervention for pressure ulcer, Rehabilitation training
- Keywords
- Refined nursing, Coma, Rehabilitation training
- Medical subject headings
- Brain Injuries, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Establishment of a hierarchical monitoring and management teamBehavioural
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 injuryBehavioural
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.
CommunicationBehavioural
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 ulcerBehavioural
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 trainingBehavioural
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 membersBehavioural
timely introduction of the current patient's condition to family members to alleviate their concerns
maintaining appropriate temperature and humidity in the wardBehavioural
maintaining appropriate temperature (20 ℃~22 ℃) and humidity (60.0%~70.0%) in the ward
careful observation of vital signs in patientsBehavioural
careful observation of vital signs such as heart rate, blood oxygen saturation, and blood pressure in patients
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | Establishment of a hierarchical monitoring and management team, Assessment of pressure injury, Communication, Intervention for pressure ulcer, Rehabilitation training Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 2 months after rehabilitation treatment
incidence of adverse reactions
Incidence (%)=Number of patients with complications/48×100%
Measured: one day before the intervention
incidence of adverse reactions
Incidence (%)=Number of patients with complications/48×100%
Measured: 2 months after rehabilitation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start1 May 2022
- Primary completion31 May 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinxiang Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Yang, Principal investigator, Xinxiang Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329934
- Sponsor's protocol ID
- XXZY-003
- Status last verified
- May 2022
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Refined Nursing in Rehabilitation Training for Patients With Brain Injury During the Recovery Period: An Observational Study
- ClinicalTrials.gov ID
- NCT06329934
- Acronym / sponsor ID
- XXZY-003
- Conditions
- Brain Injuries
- Keywords
- Refined nursing, Coma, Rehabilitation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Xinxiang Central HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Behavioral: Establishment of a hierarchical monitoring and management team, Behavioral: Assessment of pressure injury, Behavioral: Communication, Behavioral: Intervention for pressure ulcer, Behavioral: Rehabilitation trainingEstablishment of a hierarchical monitoring and management team, Assessment of pressure injury, Communication, Intervention for pressure ulcer, Rehabilitation training |
| the control group | Active comparator | 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 patientstimely 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 |
Who may qualify
- Ages
- 33 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Establishment of a hierarchical monitoring and management teamTo 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. | Behavioural | the intervention group |
| Assessment of pressure injuryBased 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. | Behavioural | the intervention group |
| CommunicationThrough 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 | Behavioural | the intervention group |
| Intervention for pressure ulcerFor 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. | Behavioural | the intervention group |
| Rehabilitation trainingAfter 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 | Behavioural | the control group, the intervention group |
| introduction of the current patient's condition to family memberstimely introduction of the current patient's condition to family members to alleviate their concerns | Behavioural | the control group |
| maintaining appropriate temperature and humidity in the wardmaintaining appropriate temperature (20 ℃~22 ℃) and humidity (60.0%~70.0%) in the ward | Behavioural | the control group |
| careful observation of vital signs in patientscareful observation of vital signs such as heart rate, blood oxygen saturation, and blood pressure in patients | Behavioural | the control group |
Primary outcome
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
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
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)
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)
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)
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)
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
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
incidence of adverse reactions
Time frame: one day before the intervention
Incidence (%)=Number of patients with complications/48×100%
incidence of adverse reactions
Time frame: 2 months after rehabilitation treatment
Incidence (%)=Number of patients with complications/48×100%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Yang principal investigator
Xinxiang Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Establishment of a hierarchical monitoring and management team, Assessment of pressure injury and Communication in people with Brain Injuries, run by Xinxiang Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GCS scores (time frame: one day before the intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.