Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-04-07 @ 1:53 AM
Study NCT ID:
NCT07211906
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-08
First Post:
2025-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Oral Nursing Education on Oral Health and Quality of Life in Patients With Home Non-Invasive Ventilator
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
Official Title:
Effects of Oral Nursing Education on Oral Health and Quality of Life in Patients With Home Non-Invasive Ventilator
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluated the impact of oral care guidance on oral health and quality of life in patients using non-invasive ventilation at home. Using a randomized controlled trial, results showed significant improvements in oral hygiene, overall health, sleep quality, and daily living after the intervention. Additionally, better oral care was positively associated with enhanced sleep quality and overall well-being. The findings suggest that targeted oral health education can effectively improve the health and quality of life for home non-invasive ventilation users, supporting its integration into clinical practice.
Detailed Description:
This study focused on exploring how providing specific oral care guidance can benefit individuals who rely on non-invasive ventilation (NIV) at home. Non-invasive ventilation is a respiratory support method used by people suffering from chronic respiratory conditions, such as COPD (chronic obstructive pulmonary disease), to help them breathe more easily without the need for invasive procedures like intubation.
The research aimed to see whether improving oral hygiene through targeted education could positively impact these patients' oral health, sleep quality, and overall quality of life. Since poor oral health has been linked to respiratory infections and other health complications, the study hypothesized that better oral care might help reduce related problems and enhance daily living.
In the study, participants receiving NIV at home were divided into two groups: one received comprehensive oral health guidance and education tailored to their needs, while the control group continued with usual care without additional instruction. The intervention included instructions on proper oral hygiene practices, such as effective brushing and oral cleaning, tailored to the specific needs of NIV users, and was provided over a period of three months.
Throughout the study, the researchers collected data on various aspects including oral health status, sleep quality, and overall life satisfaction. They used validated questionnaires like the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep and the Oral Health Impact Profile-14 (OHIP-14) to assess oral health-related quality of life.
The results demonstrated that patients who received the oral care guidance showed significant improvements in their oral health, sleep quality, and overall well-being compared to those in the control group. The intervention not only helped with maintaining better oral hygiene but also contributed to a better sleep experience and higher quality of life, reducing the negative impacts associated with respiratory diseases and the challenges of long-term NIV use.
Importantly, implementing such educational programs in clinical settings can empower patients to take better care of their oral health, which in turn may reduce the risk of infections and other complications, ultimately improving their daily lives. The study highlights the importance of integrating oral health education into the routine care for patients with chronic respiratory conditions on home NIV, emphasizing a holistic approach to patient health and quality of life.
The research aimed to see whether improving oral hygiene through targeted education could positively impact these patients' oral health, sleep quality, and overall quality of life. Since poor oral health has been linked to respiratory infections and other health complications, the study hypothesized that better oral care might help reduce related problems and enhance daily living.
In the study, participants receiving NIV at home were divided into two groups: one received comprehensive oral health guidance and education tailored to their needs, while the control group continued with usual care without additional instruction. The intervention included instructions on proper oral hygiene practices, such as effective brushing and oral cleaning, tailored to the specific needs of NIV users, and was provided over a period of three months.
Throughout the study, the researchers collected data on various aspects including oral health status, sleep quality, and overall life satisfaction. They used validated questionnaires like the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep and the Oral Health Impact Profile-14 (OHIP-14) to assess oral health-related quality of life.
The results demonstrated that patients who received the oral care guidance showed significant improvements in their oral health, sleep quality, and overall well-being compared to those in the control group. The intervention not only helped with maintaining better oral hygiene but also contributed to a better sleep experience and higher quality of life, reducing the negative impacts associated with respiratory diseases and the challenges of long-term NIV use.
Importantly, implementing such educational programs in clinical settings can empower patients to take better care of their oral health, which in turn may reduce the risk of infections and other complications, ultimately improving their daily lives. The study highlights the importance of integrating oral health education into the routine care for patients with chronic respiratory conditions on home NIV, emphasizing a holistic approach to patient health and quality of life.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: