Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)NCT07050602
Health Belief Model Nursing for Moderate to Severe OSAHS Post-Surgery
A study testing Health Belief Model Nursing Intervention and Routine Care in people with Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) and Postoperative Care, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS), Postoperative Care
- What is being tested?
- Health Belief Model Nursing Intervention and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Long-term Efficacy of Health Belief Model Nursing Intervention in Preventing and Treating Moderate to Severe OSAHS in Post-surgery Patients
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.
Read the 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.
- Being tested
- Health Belief Model Nursing Intervention, Routine Care
- Keywords
- Health Belief Model, Moderate to Severe OSAHS, Postoperative Intervention, Nursing Intervention, Long-term Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model Nursing InterventionBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Measured by Polysomnography (PSG). Lower values indicate better outcome.
Measured: 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.
Measured: 6 months and 12 months post-operation.
Secondary outcomes (5)
Oxygen Desaturation Index (ODI)
Measured by Polysomnography (PSG). Lower values indicate better outcome.
Measured: Baseline (immediately after operation) and 6 months post-intervention.
Pittsburgh Sleep Quality Index (PSQI) Score
Assessed using the PSQI questionnaire (19 questions, 7 components, total score 0-21). Lower scores indicate better sleep quality.
Measured: 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
Assessed by a questionnaire covering Knowledge Understanding, Adjustment of Daily Life, and Coping Strategies. Each dimension scored 0-10. Higher scores indicate better ability.
Measured: Post-intervention (specific time point, likely at 6 months and/or 1 year).
Postoperative Quality of Life
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.
Measured: Post-intervention (specific time point, likely at 6 months and/or 1 year).
Patient Satisfaction with Postoperative Care
Assessed by a survey classifying satisfaction as Very Satisfied, Satisfied, General Satisfaction, Dissatisfied. Total satisfaction rate calculated.
Measured: 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Mar 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuai Chen, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050602
- Sponsor's protocol ID
- 20160703
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Health Belief Model Nursing Intervention in Preventing and Treating Moderate to Severe OSAHS in Post-surgery Patients
- ClinicalTrials.gov ID
- NCT07050602
- Acronym / sponsor ID
- 20160703
- Keywords
- Health Belief Model, Moderate to Severe OSAHS, Postoperative Intervention, Nursing Intervention, Long-term Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation Group | Experimental | Behavioral: Health Belief Model Nursing Intervention, Behavioral: Routine CareParticipants 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). |
| Control Group | Active comparator | Behavioral: Routine CareParticipants 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Belief Model Nursing InterventionParticipants 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). | Behavioural | Observation Group |
| Routine CareParticipants 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. | Behavioural | Control Group, Observation Group |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: Baseline (immediately after operation) and 6 months post-intervention.
Measured by Polysomnography (PSG). Lower values indicate better outcome.
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.
5 secondary outcomes
Oxygen Desaturation Index (ODI)
Time frame: Baseline (immediately after operation) and 6 months post-intervention.
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).
Self-Management Ability
Time frame: Post-intervention (specific time point, likely at 6 months and/or 1 year).
Postoperative Quality of Life
Time frame: Post-intervention (specific time point, likely at 6 months and/or 1 year).
Patient Satisfaction with Postoperative Care
Time frame: 6 months post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model Nursing Intervention and Routine Care in people with Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) and Postoperative Care, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: Baseline (immediately after operation) and 6 months post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.