- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05563207
Application of Health Education Path of Traditional Chinese Medicine Nursin
September 30, 2022 updated by: Jianhua Zhang, Shijiazhuang Pingan Hospital
Shijiazhuang Pingan Hospital
To explore the effect of traditional Chinese medicine (TCM) health education standard path on the treatment of patients with acute myeloid leukemia (AML).
A total of 60 patients with acute myeloid leukemia in Shijiazhuang Ping An Hospital were selected and divided into control group (n=30) and observation group (n=30) according to the time of admission.
Both groups received the same chemotherapy, the control group received routine nursing, and the observation group received TCM health education standard path intervention.
The scores of Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), Spitzer Quality of Life Index (QLI), awareness of TCM health education standard path content and nursing satisfaction were compared between the two groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: traditional Chinese medicine health education standard path
- Other: The contents of the health intervention mainly included:Graphic and text education
- Other: The contents of the health intervention mainly included:Language education
- Other: The contents of the health intervention mainly included:Psychological education
- Other: The contents of the health intervention mainly included:Dietary education
- Other: The contents of the health intervention mainly included:Complication education
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
Hebei
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Shijiazhuang, Hebei, China, 050021
- Shijiazhuang Pingan Hospital
-
-
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
37 years to 68 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients admitted to the hospital for the first time during the observation period
- patients who met the diagnostic criteria for AML
- patients with stable disease, clear consciousness, fluent speech, and normal communication
- patients who volunteered to participate in the research
Exclusion Criteria:
- patients who were repeatedly admitted to hospital during the investigation period
- patients with hospitalization time ≤3 days
- patients whose condition changed after admission and could not continue to cooperate with the investigation
- patients who asked to withdraw during the observation period.
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: control group
Both groups of patients were given routine treatment, and were intervened by the same batch of nursing staff.
Among them, patients in the control group were given intervention for TCM health education standard path.
During chemotherapy, the patient's condition was closely observed, patiently listened to the patient's chief complaint, answered their questions, and instructed the patient to follow the doctor's instructions to prevent complications such as infection and bleeding.
|
Both groups of patients were given routine treatment, and were intervened by the same batch of nursing staff.During chemotherapy, the patient's condition was closely observed, patiently listened to the patient's chief complaint, answered their questions, and instructed the patient to follow the doctor's instructions to prevent complications such as infection and bleeding.
|
|
ACTIVE_COMPARATOR: observation group
The patients in the observation group were given TCM health education standard path intervention.
The contents of the health intervention mainly included: ① Graphic and text education;②Language education;③ Psychological education; ④Dietary education; ⑤ Complication education
|
Both groups of patients were given routine treatment, and were intervened by the same batch of nursing staff.During chemotherapy, the patient's condition was closely observed, patiently listened to the patient's chief complaint, answered their questions, and instructed the patient to follow the doctor's instructions to prevent complications such as infection and bleeding.
When the patient was admitted to the hospital, the responsible nurse had a comprehensive understanding of the patient's disease cognition and psychological state, and based on this, an individualized intervention plan was formulated.
With the help of publicity boards, brochures and other forms of pictures and texts, to popularize the knowledge and precautions of disease treatment for patients
adopt one-to-one method to inform patients of the principles, effects and precautions of chemotherapy, eliminate patients' misunderstandings, and repeat language education for many times during the treatment process to strengthen patients' memory
guide patients to express their own emotions, according to the patient's personality, cultural background, etc., after communicating with family members and negotiating, selectively inform the patient's actual condition
instruct patients to follow the principles of light, easy to digest and balanced nutrition
Actively inform patients about complications in advance, and guide their prevention methods, such as increasing water intake, avoiding activities of affected limbs after chemotherapy, etc. Patients with vomiting, hair loss and other adverse reactions are prone to negative emotions such as anxiety and depression , timely take corresponding measures and appease the patient, inform them that it is a normal phenomenon, and guide them to maintain a good attitude.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-rating anxiety scale
Time Frame: 3 months of intervention
|
evaluate the anxiety of the two groups of patients before and after intervention
|
3 months of intervention
|
|
self-rating depression scale
Time Frame: 3 months of intervention
|
evaluate depression of the two groups of patients before and after intervention
|
3 months of intervention
|
|
Quality of Life Index
Time Frame: 3 months of intervention
|
the Spitzer Quality of Life Index (QLI) was used to evaluate the quality of life of patients
|
3 months of intervention
|
|
Self-made questionnaires to compare the awareness of traditional Chinese medicine health education standard path content
Time Frame: 3 months of intervention
|
5 items of propaganda and education content, propaganda and education form, professional level of propaganda and education, nurses' professional attitude, and propaganda and education effect
|
3 months of intervention
|
|
Self-made questionnaires to compare nursing satisfaction
Time Frame: 3 months of intervention
|
evaluate the nursing attitude, nursing skills, and explanations of medical staff
|
3 months of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2021
Primary Completion (ACTUAL)
May 31, 2022
Study Completion (ACTUAL)
May 31, 2022
Study Registration Dates
First Submitted
September 26, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (ACTUAL)
October 3, 2022
Study Record Updates
Last Update Posted (ACTUAL)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 30, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ShijiazhuangPinganH
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.
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