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临床试验/NCT07050602
NCT07050602已完成不适用

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

The First Hospital of Hebei Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Apnea-Hypopnea Index (AHI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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).

干预措施: Health Belief Model Nursing Intervention (Behavioral)

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).

干预措施: Routine Care (Behavioral)

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.

干预措施: Routine Care (Behavioral)

结局指标

主要结局

Apnea-Hypopnea Index (AHI)

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

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

OSAHS Recurrence Rate

时间窗: 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.

次要结局

  • 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).)
  • Oxygen Desaturation Index (ODI)(Baseline (immediately after operation) and 6 months post-intervention.)
  • Self-Management Ability(Post-intervention (specific time point, likely at 6 months and/or 1 year).)
  • Patient Satisfaction with Postoperative Care(6 months post-intervention.)
  • Postoperative Quality of Life(Post-intervention (specific time point, likely at 6 months and/or 1 year).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shuai Chen

Principal investigator

The First Hospital of Hebei Medical University

研究点 (1)

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