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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Hebei
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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
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.
Other: 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
Other: 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
Other: 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
Other: The contents of the health intervention mainly included:Dietary education
instruct patients to follow the principles of light, easy to digest and balanced nutrition
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shijiazhuang Pingan Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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