Health Belief Model Nursing for Moderate to Severe OSAHS Post-Surgery

NCT07050602 | Completed

• 1 other identifier: 20160703
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the long-term preventive and therapeutic effects of a health belief model (HBM)-based nursing intervention compared to routine care in patients with moderate to severe Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) after surgery. The study assessed impacts on sleep parameters (Apnea-Hypopnea Index, Oxygen Desaturation Index, sleep quality via PSQI), self-management abilities, quality of life, OSAHS recurrence rate, and patient satisfaction.

Conditions

Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS); Postoperative Care

Keywords

Health Belief Model; Moderate to Severe OSAHS; Postoperative Intervention; Nursing Intervention; Long-term Prevention

Outcome Measures

Primary Outcomes (2)

• Apnea-Hypopnea Index (AHI)

  Measured by Polysomnography (PSG). Lower values indicate better outcome.

  Baseline (immediately after operation) and 6 months post-intervention.

• OSAHS Recurrence Rate

  Calculated as the percentage of patients experiencing relapse (defined by AHI levels and symptom reappearance) within one year. Lower rates indicate better outcome.

  6 months and 12 months post-operation.

Secondary Outcomes (5)

• Oxygen Desaturation Index (ODI)

  Baseline (immediately after operation) and 6 months post-intervention.

• Pittsburgh Sleep Quality Index (PSQI) Score

  Post-intervention (specific time point after 6 months or 1 year should be clarified, likely at 6 months and/or 1 year).

• Self-Management Ability

  Post-intervention (specific time point, likely at 6 months and/or 1 year).

• Postoperative Quality of Life

  Post-intervention (specific time point, likely at 6 months and/or 1 year).

• Patient Satisfaction with Postoperative Care

  6 months post-intervention.

Study Arms (2)

Observation Group

EXPERIMENTAL

Participants received routine postoperative care plus a one-year health belief model nursing intervention. This included: comprehensive assessment and psychological interventions (Perceived Susceptibility); education on OSAHS risks and consequences (Perceived Severity); weekly weight/blood pressure monitoring, dietary/exercise guidance, sleep posture correction aids, and a daily health diary (Perceived Benefits); and regular phone follow-ups (2-3 times/week for 0-8 weeks post-discharge, bi-weekly up to 1 year) for support and addressing difficulties (Perceived Barriers).

Behavioral: Health Belief Model Nursing Intervention; Behavioral: Routine Care

Control Group

ACTIVE COMPARATOR

Participants received routine postoperative care for OSAHS for one year, including general education, dietary and exercise guidance. Post-discharge monitoring was conducted via monthly phone calls.

Behavioral: Routine Care

Interventions

Health Belief Model Nursing Intervention BEHAVIORAL

Participants received a one-year health belief model nursing intervention. This included: comprehensive assessment and psychological interventions (Perceived Susceptibility); education on OSAHS risks and consequences (Perceived Severity); weekly weight/blood pressure monitoring, dietary/exercise guidance, sleep posture correction aids, and a daily health diary (Perceived Benefits); and regular phone follow-ups (2-3 times/week for 0-8 weeks post-discharge, bi-weekly up to 1 year) for support and addressing difficulties (Perceived Barriers).

Observation Group

Routine Care BEHAVIORAL

Participants received routine postoperative care for OSAHS for one year, including general education, dietary and exercise guidance. Post-discharge monitoring was conducted via monthly phone calls.

Control Group; Observation Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 30 and 50 years old;
• Sleep Apnea Hypopnea Index (AHI) \> 21 events per hour;
• Body Mass Index (BMI) ≥ 28 kg/m²;
• The obstructive plane of OSAHS was either at the soft palate level or associated with narrowing at the tongue base level;
• Surgical treatments included uvulopalatopharyngoplasty (UPPP) or UPPP combined with low-temperature plasma ablation of the tongue base/tongue body;
• The patient had undergone surgical treatment for OSAHS;
• The patient could comprehend the research details and voluntarily signed an informed consent form.

You may not qualify if:

• Severe cardiovascular disease, kidney disease, liver disease, or dysfunction of other major organs;
• Severe mental illness or cognitive dysfunction that would hinder understanding or adherence to research procedures;
• Presence of other sleep disorders, such as central sleep apnea or insomnia;
• Use of medications that could interfere with sleep patterns;
• Pregnancy or lactation;
• Patients unwilling to provide informed consent for the study.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 3, 2025
• Study Start: March 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

CN (1)