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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05563207
Other study ID # ShijiazhuangPinganH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date May 31, 2022

Study information

Verified date September 2022
Source Shijiazhuang Pingan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 37 Years to 68 Years
Eligibility 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 Design


Intervention

Other:
traditional Chinese medicine health education standard path
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.
The contents of the health intervention mainly included:Graphic and text education
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
The contents of the health intervention mainly included:Language education
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
The contents of the health intervention mainly included:Psychological education
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
The contents of the health intervention mainly included:Dietary education
instruct patients to follow the principles of light, easy to digest and balanced nutrition
The contents of the health intervention mainly included:Complication education
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.

Locations

Country Name City State
China Shijiazhuang Pingan Hospital Shijiazhuang Hebei

Sponsors (1)

Lead Sponsor Collaborator
Shijiazhuang Pingan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-rating anxiety scale evaluate the anxiety of the two groups of patients before and after intervention 3 months of intervention
Primary self-rating depression scale evaluate depression of the two groups of patients before and after intervention 3 months of intervention
Primary Quality of Life Index the Spitzer Quality of Life Index (QLI) was used to evaluate the quality of life of patients 3 months of intervention
Primary Self-made questionnaires to compare the awareness of traditional Chinese medicine health education standard path content 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
Primary Self-made questionnaires to compare nursing satisfaction evaluate the nursing attitude, nursing skills, and explanations of medical staff 3 months of intervention
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