NCT03949114

Brief Summary

  1. 1.A questionnaire on "Cognition and Attitudes of Nurses on Postoperative Deafness in Neurosurgical Patients" was initially formed through reference literature and expert opinions. The content includes two dimensions of knowledge and attitude, all of which are single-choice questions. There are 11 items in the knowledge dimension, 1 point for the correct answer, 0 point for the wrong answer, and 0 to 11 points for the total score. The average score is the average score and the score of the score is the average score. The average score is ≤60%. Knowledge; attitude dimension is 7 items, using the Likert 4 rating method, "very disagree \~ very agree" count "1 to 4 points", total score 7 to 28 points. A sample questionnaire survey was conducted among non-severe unit nurses in the top three hospitals in the province to understand the level of cognitive mastery of the neurosurgical nurses in the province and the current status of interventions, and to compare the attitudes of nurses with different academic qualifications, years of work and work experience to postoperative intervention. And the level of knowledge mastery.
  2. 2.Patients who underwent surgery on the neurosurgery in our hospital from December 31, 2010 to December 31, 2019 were used as the control group. After informed notification, the patients with the enrollment conditions were screened for Fried's debilitating phenotype and performed. Post-routine care; patients who underwent craniotomy in our department of neurosurgery from January 1, 2020 to June 31, 2020 were included in the intervention. Patients who met the criteria for admission were informed and informed consent was obtained. Develop an early rehabilitation process to guide patients to systematic early rehabilitation training. To compare the incidence of debilitating, sputum incidence (Nursing Delirium Screening Scale, Nu-DESC), sputum-related adverse events, Activity of Daily Living (ADL), patient satisfaction, etc. The clinical application effect of the early rehabilitation intervention system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

May 10, 2019

Last Update Submit

May 10, 2019

Conditions

Keywords

neurosurgery

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of postoperative delirium

    use the NU-DESC to assess every postoperative patients,to see the incidence of postoperative delirium

    The first to fifth day after surgery

Other Outcomes (2)

  • Daily life ability

    One week after discharged

  • Daily life ability

    One month after discharged

Study Arms (2)

test group

EXPERIMENTAL

1\) Performing a weak debilitating phenotype screening on the patients before surgery; (2) Do the early rehabilitation intervention process:

Behavioral: EvaluationBehavioral: rehabilitation

Control group

ACTIVE COMPARATOR

1\) Performing a weak debilitating phenotype screening on the patients before surgery; (2) Patients in the control group were treated according to the general nursing routine after neurosurgery;

Behavioral: EvaluationBehavioral: nursing care

Interventions

EvaluationBEHAVIORAL

Evaluate a weak debilitating phenotype screening on the patients before surgery;

Also known as: Fried assessment
Control grouptest group
nursing careBEHAVIORAL

Traditional post-operative nursing care

Also known as: post-operative nursing care
Control group
rehabilitationBEHAVIORAL

1. Postoperative vital signs were stabilized for 2 hours and then assisted to turn over; 2 to 3 hours to change position, awake without swallowing dysfunction, to fluid diet; 6 hours later, raise the bed 15 to 30 °, eat a half-flow diet. 2. On the first day after surgery, raise the bed 45 °, row and position training; catheter clamping training; assessment of pain, preventive analgesia. Early rehabilitation training was performed for 60 minutes each time for 5 consecutive days.

Also known as: ERAS
test group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with clear consciousness after neurosurgery craniotomy;
  • Sign the research informed consent form.

You may not qualify if:

  • Patients have a history of cognitive dysfunction, mental illness, senile dementia, and stroke before surgery;
  • Patients and their families with poor behavioral compliance;
  • Patients with drug dependence and alcohol dependence; -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Delirium

Interventions

Nursing CareRehabilitation

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesAftercareContinuity of Patient Care

Central Study Contacts

Minglan Zhu, master

CONTACT

Qiuping Gu, Bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Responsible nurses will conduct daily life skills and sputum assessments for all patients, and the data collector will collect the data needed for the study.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: During the period from June 1, 2019 to December 31, 2019, 150 patients with craniotomy who met the criteria and signed informed consent were included in the control group, from January 1, 2020 to June 30, 2020. During the period, 150 patients who met the standard neurosurgical craniotomy were included in the observation group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse manger

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 14, 2019

Study Start

May 1, 2019

Primary Completion

June 30, 2021

Study Completion

October 31, 2021

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

Locations