- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06473220
Evaluation of the Effectiveness of Narrative Nursing
June 23, 2024 updated by: Fang Honglian, Nanjing Medical University
Evaluation of the Effectiveness of Narrative Nursing in Patients With Alzheimer's Disease
To explore the effects of narrative nursing on mental state, life ability and emotion of patients with Alzheimer's disease (AD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is no effective clinical treatment, mainly through taking Western drugs to control the Alzheimer's disease, but the treatment cycle is long, the cost of drugs is high, and the patient's family nee care, resulds long-termting in a huge economic and psychological burden on the patient and family recipients.
Narrative nursing is an intervention mode of psychological nursing.In practice, narrative nursing can guide patients to actively organize experiences into various events with certain practical significance, attach importance to personal feelings and experiences, promote the psychological growth of patients and promote the generation of upward motivation.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210029
- Gulou District
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease.
- Forgetting is the main cognitive impairment;.
- The patient has basic language communication ability.
- Patients were treated with the same regimen.
Exclusion Criteria:
- Patients with other common neurological and mental disorders (depression, psychosis, vascular cognitive impairment).
- Patients with heart, liver and other vital organ dysfunction.
- Patients with severe cardiovascular disease.
- Patients with severe physical disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Reference group
The reference group carried out routine nursing, that is, the most appropriate intervention measures were properly formulated according to the actual condition degree and various levels of physical fitness of the patients, and the patients were urged to take drugs according to the doctor's advice every day.
Nurses should conduct oral health promotion for patients; Administering medication and a daily healthy diet regimen; Patients with orientation and language communication disorders were given nursing care step by step.
Continuous care for 2 months.
|
Narrative nursing is an intervention mode of psychological nursing.
|
|
Experimental: Study group
The research group cooperated with the implementation of narrative nursing.
The detailed measures are as follows: ① Establish a narrative nursing special group.
② Narrative data collection.
③ Pay attention to the scientific evaluation of narrative content.
④ Edit the narrative reasonably.
⑤ Strengthen interview intervention.
Continuous care for 2 months.
|
Narrative nursing is an intervention mode of psychological nursing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MMSE sore
Time Frame: After 1, 2 and 4 weeks after hospitalization
|
The simple mental state Intelligence Scale (MMSE) was used to evaluate the mental state of the patients before and after the nursing intervention.
The scale was mainly composed of 5 dimensions, namely orientation ability, recall ability, memory ability, attention and calculation ability, and language ability, and contained a total of 30 items.
The total score was 0-30 points, the higher the score, the better the mental state of the patients.
|
After 1, 2 and 4 weeks after hospitalization
|
|
ESCA score
Time Frame: After 1, 2 and 4 weeks after hospitalization
|
The self-care ability measurement (ESCA) scale was used to evaluate the practical self-care ability of patients in the two groups before and after nursing intervention.
The scale was mainly composed of four dimensions: self-concept, health knowledge mastery level, sense of responsibility, and self-care practical skills, and contained 43 items with a total score of 0-172.
It shows that the actual ability of self-care is better.
|
After 1, 2 and 4 weeks after hospitalization
|
|
HAMD score
Time Frame: After 1, 2 and 4 weeks after hospitalization
|
The score consisted of 17 items, including self-awareness, work and interest, gastrointestinal symptoms, weight loss, hypochondriasis, sleep difficulty, etc.
The total score < 7 was considered normal, 7 to 17 divided into possible depression syndrome, > 17-24 were classified as having depression, and> 24 were classified as major depression.
|
After 1, 2 and 4 weeks after hospitalization
|
|
HAMA score
Time Frame: After 1, 2 and 4 weeks after hospitalization
|
The score includes two dimensions: spirituality and physicality, with a total of 14 items, including gastrointestinal and digestive symptoms, depressive mood, sensory system symptoms, behavioral manifestations when communicating with others, somatic anxiety, cognitive function, etc.
The total score is > 28, which is classified as severe anxiety, 21 to 28 grades are anxious, 14 to < 21 is classified as anxiety, 7 to < 14 scores may have anxiety, and <7 is considered normal.
|
After 1, 2 and 4 weeks after hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Huang C ying, Bachelor, The Affiliated Brain Hospital of Nanjing Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Actual)
October 1, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
June 18, 2024
First Submitted That Met QC Criteria
June 23, 2024
First Posted (Actual)
June 25, 2024
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 23, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 310638478
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Respect privacy rights.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.