Meticulous nursing combined with humanistic care
| ISRCTN | ISRCTN13993861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13993861 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Huainan Science and Technology Bureau |
| Funder | Huainan City Science and Technology Plan Project (Research on the Establishment and Application of Continuing Care Plan for Elderly Chronic Disease Patients Based on Discharge Preparedness and IKAP Theory) |
- Submission date
- 30/07/2024
- Registration date
- 05/08/2024
- Last edited
- 02/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Pulmonary (chest/lung) infections can have a significant psychological impact on patients, leading to increased stress, anxiety and depression. Effective nursing interventions are of great significance during clinical treatment. The concept of humanistic care refers to a novel nursing approach that emphasizes the importance of patient-centered and individualized care, with the overall goal of providing comfortable nursing. Meanwhile, meticulous nursing has been widely applied in various clinical departments and has achieved satisfactory clinical outcomes. This study is designed to explore the combined effects of these two nursing models on disease-perceived stress and self-management efficacy in patients with pulmonary infections.
Who can participate?
Patients with pulmonary infection. The observation group: 15 males and 22 females, aged 20-91 years, with a body mass index (BMI) of 16.02 to 37.79 kg/m2. The control group: 15 males and 22 females, aged 20-85 years, with a BMI of 16.22 to 33.30 kg/m2.
What does the study involve?
The control group was given nursing measures based on the concept of humanistic care, and the observation group received meticulous nursing in addition to the measures provided to the control group.
What are the possible benefits and risks of participating?
The application of meticulous nursing combined with humanistic care in patients with pulmonary infections can improve patients’ disease perception and enhance their psychological state, alleviating their disease-perceived stress and improving their self-management efficacy.
Where is the study run from?
The First Affiliated Hospital of Anhui University of Science and Technology (China)
When is the study starting and how long is it expected to run for?
February 2023 to May 2024
Who is funding the study?
Huainan City Science and Technology Plan Project (China)
Who is the main contact?
Rong Xiangxia, Rrxiangxia@163.com
Contact information
Public, Scientific, Principal investigator
No.203 Huaibin Road
Tianjia'an District
Huainan City
232000
China
 ORCID ID |
0009-0002-4560-6906 |
|---|---|
| Phone | +86 (0)18949669993 |
| Rrxiangxia@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center randomized controlled intervention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of meticulous nursing combined with humanistic care on disease perceived stress and self-management efficacy in patients with pulmonary infection: a randomized controlled trial |
| Study acronym | BD |
| Study objectives | This study is designed to explore the combined effects of these two nursing models on disease-perceived stress and self-management efficacy in patients with pulmonary infections. |
| Ethics approval(s) |
Approved 12/11/2023, The ethics committee of the First Affiliated Hospital of Anhui University of Science and Technology (No.203 Huaibin Road, Tianjia'an District, Huainan City, 232000, China; +86 (0)554 3320335; xiaolixx88@hotmail.com), ref: 2023-KY-T009-001 |
| Health condition(s) or problem(s) studied | Nursing care of patients with pulmonary infections |
| Intervention | 74 patients with pulmonary infection admitted to the hospital from March 2023 to February 2024 were randomly divided into the observation group (n = 37) and the control group (n = 37) using the randomized numeric table method. Specifically, the control group was given nursing measures based on the concept of humanistic care, and the observation group received meticulous nursing in addition to the measures provided to the control group. The duration of the intervention: from when the patient was admitted to the hospital until the day of discharge. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Disease-perceived stress measured using the Chinese Illness Perception Questionnaire-Revised (CIPQ-R) pre- and post-intervention (on the day of discharge) |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 91 Years |
| Sex | All |
| Target sample size at registration | 74 |
| Total final enrolment | 74 |
| Key inclusion criteria | 1. Patients who met the relevant clinical criteria and were diagnosed with pulmonary infection by laboratory, imaging, and other examination results 2. Patients with normal mental status or sanity and good communication ability 3. Patients who had a detailed understanding of the study content and voluntarily signed the informed consent form |
| Key exclusion criteria | 1. Patients with recent hormone use or long-term hormone use 2. Patients with combined immunodeficiency disease 3. Patients with recent immunosuppression-related treatment 4. Patients with combined infections in other sites 5. Patients with combined tumor disease |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 29/02/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Tianjia'an District
Huainan City
232000
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from Rong Xiangxia (Rrxiangxia@163.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/08/2024: Study's existence confirmed by the ethics committee of the First Affiliated Hospital of Anhui University of Science and Technology.
