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

NCT07211906 | Enrolling By Invitation DMC

• 1 other identifier: 202500853B0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Oral Health Assessment Tool (OHAT)

  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

  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.

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• Chinese version of the SF-12 health survey

  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.

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants receive routine oral care guidance or standard education materials without additional digital support or structured intervention. This group serves as a baseline to evaluate the effectiveness of the tailored oral health education and digital follow-up.

Other: Control Group: oral hygiene education standard

Intervention

EXPERIMENTAL

The intervention group in this study received a structured oral care program integrated with technological support via Line communication. Specifically, participants in the experimental group were provided with personalized oral hygiene guidance through one-on-one oral care instruction, which included oral health education and demonstration. They also received continuous support and follow-up through the Line communication platform, where they could reply to educational prompts and clarify doubts, fostering adherence to oral care practices over a three-month period. This approach aimed to improve oral health outcomes and quality of life among home non-invasive ventilation users through a combination of direct guidance and digital communication.

Other: Control Group: oral hygiene education standard; Other: oral hygiene education program

Interventions

Control Group: oral hygiene education standard OTHER

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.

Control Group; Intervention

oral hygiene education program OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University Of Science and Technology

Chiayi City, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: July 1, 2025
• Primary Completion: March 29, 2026
• Study Completion: March 29, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-07

Locations

TW (1)