ISRCTN ISRCTN13993861
DOI https://doi.org/10.1186/ISRCTN13993861
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

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

Dr Xiangxia Rong
Public, Scientific, Principal Investigator

No.203 Huaibin Road
Tianjia'an District
Huainan City
232000
China

ORCiD logoORCID ID 0009-0002-4560-6906
Phone +86 (0)18949669993
Email Rrxiangxia@163.com

Study information

Study designSingle-center randomized controlled intervention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect 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 acronymBD
Study hypothesisThis 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

ConditionNursing care of patients with pulmonary infections
Intervention74 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 typeBehavioural
Primary outcome measure1. Disease-perceived stress measured using the Chinese Illness Perception Questionnaire-Revised (CIPQ-R) pre- and post-intervention (on the day of discharge)
2. Self-management efficacy measured using the Exercise of Self-Care Agency Scale (ESCA) pre- and post-intervention
3. Psychological status measured using the Hospital Anxiety and Depressing Scale (HADS) pre- and post-intervention
4. Nursing satisfaction measured using the Nursing Satisfaction Scale on the day of discharge of the patient
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/02/2023
Overall study end date01/05/2024

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit20 Years
Upper age limit91 Years
SexBoth
Target number of participants74
Total final enrolment74
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date01/03/2023
Recruitment end date29/02/2024

Locations

Countries of recruitment

  • China

Study participating centre

The First Affiliated Hospital of Anhui University of Science and Technology
No.203 Huaibin Road
Tianjia'an District
Huainan City
232000
China

Sponsor information

Huainan Science and Technology Bureau
Government

Minsheng Building
No. 86 Heyue Street
High tech Development Zone (Shannan New District)
Huainan
232000
China

Phone +86 (0)554 3322111
Email ctnma@189.cn
Website https://kjj.huainan.gov.cn/

Funders

Funder type

Government

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)

No information available

Results and Publications

Intention to publish date01/01/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal.
IPD sharing planThe datasets generated during and analysed during the current study will be available upon request from Rong Xiangxia (Rrxiangxia@163.com)

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.