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Completed

NCT Number: NCT07050602

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

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

A total of 120 post-surgery patients with moderate to severe OSAHS were recruited and assigned to either a control group (n=60) receiving routine postoperative care or an observation group (n=60) receiving a health belief model-based nursing intervention in addition to routine care. Routine care included general postoperative education for OSAHS, dietary, and exercise guidance with monthly phone follow-ups. The HBM intervention, lasting one year, focused on perceived susceptibility (assessment, psychological intervention), perceived severity (education on risks), perceived benefits (weight/BP monitoring, dietary/exercise guidance, sleep posture aids, daily diary), and perceived barriers (frequent phone follow-ups, psychological support). Outcomes were measured at baseline, 6 months, and 12 months post-surgery, including polysomnography, Pittsburgh Sleep Quality Index (PSQI), self-management ability questionnaires, quality of life questionnaires, OSAHS recurrence, and patient satisfaction surveys.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Apnea-Hypopnea Index (AHI)

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

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

  2. OSAHS Recurrence Rate

    Time frame: 6 months and 12 months post-operation.

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

Secondary outcomes

  1. Oxygen Desaturation Index (ODI)

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

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

  2. Pittsburgh Sleep Quality Index (PSQI) Score

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

    Assessed using the PSQI questionnaire (19 questions, 7 components, total score 0-21). Lower scores indicate better sleep quality.

  3. Self-Management Ability

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

    Assessed by a questionnaire covering Knowledge Understanding, Adjustment of Daily Life, and Coping Strategies. Each dimension scored 0-10. Higher scores indicate better ability.

  4. Postoperative Quality of Life

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

    Assessed by a self-designed questionnaire covering Sleep Quality, Daytime Function, Mental State, and Overall Satisfaction. Each category scored 0-10. Higher scores indicate better quality of life.

  5. Patient Satisfaction with Postoperative Care

    Time frame: 6 months post-intervention.

    Assessed by a survey classifying satisfaction as Very Satisfied, Satisfied, General Satisfaction, Dissatisfied. Total satisfaction rate calculated.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Long-term Efficacy of Health Belief Model Nursing Intervention in Preventing and Treating Moderate to Severe OSAHS in Post-surgery Patients

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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