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

NCT ID: NCT07050602

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2023-12-31

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Observation Group

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).

Group Type: EXPERIMENTAL

Health Belief Model Nursing Intervention

Intervention Type: 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

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Routine Care

Intervention Type: 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.

Interventions

Health Belief Model Nursing Intervention

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).

Intervention Type: BEHAVIORAL

Routine Care

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shuai Chen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

20160703

Identifier Type: -

Identifier Source: org_study_id