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Rehabilitation Intervention on Prevention of Postoperative Delirium

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ClinicalTrials.gov Identifier: NCT03949114
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
zhuminglan, Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
  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. 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.

Condition or disease Intervention/treatment Phase
Delirium Eras Behavioral: Evaluation Behavioral: nursing care Behavioral: rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Early Rehabilitation Intervention on Prevention of Postoperative Delirium in Neurosurgical Patients
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: test group

1) Performing a weak debilitating phenotype screening on the patients before surgery;

(2) Do the early rehabilitation intervention process:

Behavioral: Evaluation
Evaluate a weak debilitating phenotype screening on the patients before surgery;
Other Name: Fried assessment

Behavioral: rehabilitation
  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.
Other Name: ERAS

Active Comparator: Control group
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: Evaluation
Evaluate a weak debilitating phenotype screening on the patients before surgery;
Other Name: Fried assessment

Behavioral: nursing care
Traditional post-operative nursing care
Other Name: post-operative nursing care




Primary Outcome Measures :
  1. Incidence rate of postoperative delirium [ Time Frame: The first to fifth day after surgery ]
    use the NU-DESC to assess every postoperative patients,to see the incidence of postoperative delirium


Other Outcome Measures:
  1. Daily life ability [ Time Frame: One week after discharged ]
    Use Barthel Index to assess the activity of daily living ability

  2. Daily life ability [ Time Frame: One month after discharged ]
    Use Barthel Index to assess the activity of daily living ability



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949114


Contacts
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Contact: Minglan Zhu, master 13757118931 ext 0571-87784713 1161625519@qq.com
Contact: Qiuping Gu, Bachelor 137773161958 ext 0571-87784713 389612248@qq.com

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Recruiting
Hangzhou, Zhejiang, China
Contact: Minglan Zhu, master    13757118731    1161625519@qq.com   
Contact: Qiuping Gu, Bachelor    13777361958    389612248@qq.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: zhuminglan, nurse manger, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03949114    
Other Study ID Numbers: 2019-022
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by zhuminglan, Second Affiliated Hospital, School of Medicine, Zhejiang University:
neurosurgery
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders