Acute Myeloid LeukemiaNCT05563207
Application of Health Education Path of Traditional Chinese Medicine Nursin
A study testing traditional Chinese medicine health education standard path, The contents of the health intervention mainly included:Graphic and text education and The contents of the health intervention mainly included:Language education in people with Acute Myeloid Leukemia, run by Shijiazhuang Pingan Hospital at 1 site in China.
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)… Read more about this study
- Who is it for?
- Ages 37 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- traditional Chinese medicine health education standard path, The contents of the health intervention mainly included:Graphic and text education and The contents of the health intervention mainly included:Language education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- traditional Chinese medicine health education standard path, The contents of the health intervention mainly included:Graphic and text education, The contents of the health intervention mainly included:Language education, The contents of the health intervention mainly included:Psychological education, The contents of the health intervention mainly included:Dietary education
- Keywords
- acute myeloid leukemia, health education, traditional Chinese medicine nursing
- Medical subject headings
- Leukemia, Myeloid, Acute, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicine health education standard pathOther
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 educationOther
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 educationOther
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 educationOther
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 educationOther
instruct patients to follow the principles of light, easy to digest and balanced nutrition
The contents of the health intervention mainly included:Complication educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | 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. Receives: Other: traditional Chinese medicine health education standard path |
| observation group | Active comparator | 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-rating anxiety scale
evaluate the anxiety of the two groups of patients before and after intervention
Measured: 3 months of intervention
self-rating depression scale
evaluate depression of the two groups of patients before and after intervention
Measured: 3 months of intervention
Quality of Life Index
the Spitzer Quality of Life Index (QLI) was used to evaluate the quality of life of patients
Measured: 3 months of intervention
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
Measured: 3 months of intervention
Self-made questionnaires to compare nursing satisfaction
evaluate the nursing attitude, nursing skills, and explanations of medical staff
Measured: 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Mar 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Pingan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhua Zhang, Shijiazhuang Pingan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563207
- Sponsor's protocol ID
- ShijiazhuangPinganH
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shijiazhuang Pingan Hospital
- ClinicalTrials.gov ID
- NCT05563207
- Acronym / sponsor ID
- ShijiazhuangPinganH
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, health education, traditional Chinese medicine nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shijiazhuang Pingan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: traditional Chinese medicine health education standard pathBoth 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. |
| observation group | Active comparator | 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 educationThe 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 |
Who may qualify
- Ages
- 37 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional Chinese medicine health education standard pathBoth 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. | Other | control group, observation group |
| The contents of the health intervention mainly included:Graphic and text educationWhen 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 | Other | observation group |
| The contents of the health intervention mainly included:Language educationadopt 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 | Other | observation group |
| The contents of the health intervention mainly included:Psychological educationguide 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 | Other | observation group |
| The contents of the health intervention mainly included:Dietary educationinstruct patients to follow the principles of light, easy to digest and balanced nutrition | Other | observation group |
| The contents of the health intervention mainly included:Complication educationActively 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. | Other | observation group |
Primary outcome
Self-rating anxiety scale
Time frame: 3 months of intervention
evaluate the anxiety of the two groups of patients before and after intervention
self-rating depression scale
Time frame: 3 months of intervention
evaluate depression of the two groups of patients before and after 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
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
Self-made questionnaires to compare nursing satisfaction
Time frame: 3 months of intervention
evaluate the nursing attitude, nursing skills, and explanations of medical staff
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional Chinese medicine health education standard path, The contents of the health intervention mainly included:Graphic and text education and The contents of the health intervention mainly included:Language education in people with Acute Myeloid Leukemia, run by Shijiazhuang Pingan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rating anxiety scale (time frame: 3 months of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.