Impact of comprehensive nursing based on the "3H" theory on blood gas, recovery speed, and lung function in children with severe pneumonia
| ISRCTN | ISRCTN13393172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13393172 |
- Submission date
- 11/02/2025
- Registration date
- 26/02/2025
- Last edited
- 25/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and aims
Due to their underdeveloped immune systems and the often atypical early symptoms of pneumonia, the disease can rapidly progress to severe pneumonia, which can then significantly impair their respiratory function, leading to rapid deterioration of blood gas parameters and lung function. This study investigates the effects of comprehensive nursing based on the "3H" theory on blood gas parameters, recovery speed, and lung function in children with severe pneumonia.
Who can participate?
Children diagnosed with severe pneumonia who were treated at our hospital participated in this trial.
What does the study involve?
This study involves the clinical nursing effect of a comprehensive nursing programme on children with severe pneumonia.
What are the possible benefits and risks of participating?
The potential benefit of participating in this experiment is that children with severe pneumonia may recover their physical health faster, the risk is that without long-term follow-up, they may experience recurrence and serious complications.
Where is the study run from?
The Second Affiliated Hospital & Yuying Children’s Hospital of Wenzhou Medical University, China
When is the study starting and how long is it expected to run for?
August 2021 and February 2024
Who is funding the study?
The Second Affiliated Hospital & Yuying Children’s Hospital of Wenzhou Medical University, China
Who is the main contact?
Jie Jin, J722_J@163.com
Contact information
Public, Scientific, Principal Investigator
The Second Affiliated Hospital & Yuying Children’s Hospital of Wenzhou Medical University, No. 109 Xueyuan West Road, Lucheng District
Wenzhou
325000
China
| Phone | +86-057785676572 |
|---|---|
| J722_J@163.com |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Impact of "3H" theory-based nursing in children with severe pneumonia |
| Study acronym | 3H |
| Study objectives | Comprehensive nursing based on the "3H" hotel-style (Hotel) etiquette services, hospital (Hospital) personalized care services, and home-style (Home) warm services theory can significantly improve the recovery speed of children with severe pneumonia, improve blood gas indicators and lung function, and increase family satisfaction compared to conventional nursing. |
| Ethics approval(s) |
Approved 08/11/2021, Ethics Committee of the Second Affiliated Hospital & Yuying Children’s Hospital of Wenzhou Medical University (No. 109 Xueyuan West Road, Lucheng District, Wenzhou City, Zhejiang Province, 325000, China; +86-0577 88832693; feyyb1@163.com), ref: 2021-K-331-03 |
| Health condition(s) or problem(s) studied | Comprehensive nursing of children with severe pneumonia |
| Intervention | Brief methodology: The study group received comprehensive nursing based on the "3H" theory + routine care, the control group received only routine care. Treatment: After treatment, the study group demonstrated significantly shorter times for cough cessation, fever resolution, improvement in dyspnea, disappearance of pulmonary rales, and overall length of hospital stay compared to the control group. Before treatment, no significant differences were observed in the PaO2, SaO2, and PaCO2 levels between the two groups. However, after treatment, the study group exhibited significantly higher PaO2 and SaO2 levels and lower PaCO2 levels compared to the control group. Before treatment, our data showed that there were no significant differences between the two groups in terms of FEV1, FVC, MVV, and PEF. However, after treatment, the study group showed significantly higher levels of FEV1, FVC, MVV, and PEF compared to the control group. Family satisfaction after treatment was significantly higher in the study group compared to the control group. After the intervention, the study group had higher compliance compared to the control group, and the difference was statistically significant Total duration of treatment: one month. Follow-up: All patients in the study group were cured and returned to a healthy state. While two patients in the control group still had some sequelae, such as drowsiness and a small amount of cough. After one week of further recovery, their condition has improved. Randomisation process: All enrolled children were assigned a number, and a random number generator was used to generate a sequence of random numbers corresponding to the number of children. Odd numbers were assigned to the study group, while even numbers were assigned to the control group. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Observe the clinical indicators of cough cessation time, fever reduction time, shortness of breath improvement time, lung rales disappearance time, and hospitalization time using clinical observation data from patient medical notes two weeks after nursing 2. Compare the changes in blood gas indicators, PaO₂, SaO ₂, and PaCO ₂ using blood gas analyzer before and after intervention 3. Compare the changes in first-second forced expiratory volume (FEV1), forced vital capacity (FVC), maximum ventilation volume (MVV), peak expiratory flow rate (PEF), and FEV1/FVC ratio of lung function parameters by Pulmonary Function Test before and after intervention |
| Secondary outcome measures | Satisfaction of the child’s family with the nursing care measured using a self-designed anonymous satisfaction questionnaire two weeks after nursing |
| Overall study start date | 01/08/2021 |
| Completion date | 01/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 90 |
| Total final enrolment | 90 |
| Key inclusion criteria | 1. Diagnosed by X-ray, meeting the diagnostic criteria of *Pediatrics (8th edition)* 2. Good compliance 3. No history of drug allergies 4. The child's family members should have at least a primary school education 5. The child's family members agree to participate and sign the informed consent form |
| Key exclusion criteria | 1. Suffering from other severe pulmonary diseases 2. Complicated with liver or kidney dysfunction 3. Suffering from mental disorders 4. Complicated with other malignant tumors 5. Complicated with severe malnutrition 6. Complicated with congenital heart disease |
| Date of first enrolment | 01/11/2022 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Wenzhou City, Zhejiang Province
325000
China
Sponsor information
Hospital/treatment centre
No. 950 Donghai Street
Quanzhou City, Fujian Province
326000
China
| Phone | +86 0595-22791001 |
|---|---|
| zhaohuifeng21102@163.com | |
| Website | https://www.fyey.cn/ |
"ROR" |
https://ror.org/03wnxd135 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Universities (academic only)
- Alternative name(s)
- Second Affiliated Hospital of Wenzhou Medical University
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
11/02/2025: Study's existence confirmed by the Ethics Committee of the Second Affiliated Hospital & Yuying Children’s Hospital of Wenzhou Medical University.
