Skip to content

Effects of Oral Nursing Education on Oral Health and Quality of Life in Patients With Home Non-Invasive Ventilator

Effects of Oral Nursing Education on Oral Health and Quality of Life in Patients With Home Non-Invasive Ventilator

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07211906
Enrollment
30
Registered
2025-10-08
Start date
2025-07-01
Completion date
2026-03-29
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noninvasive Ventilators, Oral Health Care, Oral Hygiene, Quality of Life, Sleep Quality

Keywords

Oral health, Oral hygiene, Noninvasive ventilation, Quality of Life, Sleep Quality

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.

Interventions

OTHERControl Group: oral hygiene education standard

oral hygiene education Standard care: oral hygiene education standard care, which involved providing participants with printed oral health education leaflets without additional personalized instruction or digital support. Specifically, participants were assessed at baseline, and then, at one-month intervals, they received printed oral care instructions and completed follow-up assessments. This group was not provided oral education or interactive guidance via digital platforms during the study period.

OTHERoral hygiene education program

Oral hygiene education program: The oral hygiene education program includes a Line-based oral care guidance program, which involves personalized, one-on-one oral health education facilitated through the Line communication platform. The process began with an initial pre-test assessment, including interviews and questionnaire evaluations. Then, the participants engaged in the Line-guided oral care intervention, where they received tailored guidance and demonstrated

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 1\. Participants aged 18 years or older with full legal capacity. 2. Able to communicate in Mandarin or Taiwanese. 3. Currently using a non-invasive ventilator. 4. Individuals with natural dentition or complete edentulism will be included. 5. Able to operate and use the LINE communication application.

Exclusion criteria

\- 1. Individuals who are unable to independently comprehend or respond to questions. 2\. Individuals whose daily living activities rely on caregiver assistance.

Design outcomes

Primary

MeasureTime frameDescription
Oral Health Assessment Tool (OHAT)The time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.his measure evaluates various aspects of oral health, such as lips, tongue, gingiva, saliva, natural teeth, dentures, oral cleanliness, and pain, with higher scores indicating poorer oral health. The study aims to determine if the oral health education intervention can significantly improve or maintain oral health status over the three-month period

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality Index (PSQI)The time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.This measure evaluates various aspects of sleep over the past month, including sleep quality, latency, duration, efficiency, disturbances, medication use, and daytime dysfunction. Higher PSQI scores indicate poorer sleep quality over the three-month period.

Other

MeasureTime frameDescription
Chinese version of the SF-12 health surveyThe time frame for measuring outcomes in this study spans four assessment points: baseline (M0), and follow-up at one month (M1), two months (M2), and three months (M3) after the intervention.daily functioning, providing a comprehensive evaluation of the intervention's effectiveness

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026