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This study evaluates the impact of early tracheostomy speaking valve intervention on communication ability, depression levels, and quality of life in ventilator-dependent patients during the weaning phase. Participants will be randomly assigned to either an experimental group using the Passy-Muir speaking valve or a control group employing standard non-verbal communication methods. Structured questionnaires will be used at multiple time points to assess changes in patient outcomes. The study aims to provide evidence supporting the use of speaking valves to enhance communication and emotional well-being in tracheostomy patients, potentially improving recovery and care strategies.
This randomized controlled trial investigates the effects of early intervention using the Passy-Muir speaking valve on communication, depression, and quality of life in tracheostomy patients undergoing ventilator weaning. The study will enroll 70 participants from the respiratory care center at Far Eastern Memorial Hospital, randomly assigned to either the experimental group (speaking valve intervention) or the control group (standard non-verbal communication methods). Data will be collected using validated assessment tools at baseline, week 1, week 2, and week 4. The primary outcomes include improvements in patient communication, reduction in depressive symptoms, and enhancement of overall quality of life. Statistical analysis will be conducted using SPSS 22.0, employing t-tests, chi-square tests, and generalized estimating equations (GEE). Ethical considerations include informed consent, patient confidentiality, and adherence to IRB-approved protocols. Findings from this study will contribute to evidence-based practices for tracheostomy patient care and guide clinical decision-making on communication strategies during ventilator weaning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (Speaking Valve Intervention) | Experimental | Participants in the experimental group will receive early intervention using the Passy-Muir speaking valve while undergoing ventilator weaning. This intervention aims to improve communication ability, reduce depression levels, and enhance quality of life. The intervention will be implemented at four different time points (Baseline, Week 1, Week 2, Week 4), with structured assessments for effectiveness |
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| Control Group (Standard Non-Verbal Communication) | Active Comparator | Participants in the control group will continue using standard non-verbal communication methods, such as lip-reading and gestures, during ventilator weaning. This group serves as a comparison to assess the effectiveness of early speaking valve intervention in tracheostomy patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passy-Muir Speaking Valve | Device | This intervention group receives early speaking valve intervention during ventilator weaning. |
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| Measure | Description | Time Frame |
|---|---|---|
| Communication Ability (Measured using the Communication Difficulty Scale) | Communication ability will be assessed using the Communication Difficulty Scale (CDS), a validated instrument comprising 13 items designed to measure speech effectiveness in tracheostomy patients. Each item is rated on a 5-point Likert scale (0-4 per item, total score range: 0-52 points), where higher scores indicate greater communication difficulty. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3). Statistical analysis will evaluate changes in communication ability over time using generalized estimating equations (GEE), accounting for intra-subject variability and adjusting for potential confounders such as age, underlying respiratory condition, and baseline cognitive function. | From enrollment to 4 weeks post-enrollment |
| Depression (Measured using the Patient Health Questionnaire-9, PHQ-9) | Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated screening tool widely used in clinical and research settings. The PHQ-9 consists of 9 items, each rated on a 4-point Likert scale (0-3 per item, total score range: 0-27 points), where higher scores indicate greater depressive symptoms. Assessments will be conducted at baseline (T0), week 1 (T1), week 2 (T2), and week 4 (T3). Statistical analysis will evaluate changes in depression scores over time using generalized estimating equations (GEE), adjusting for potential confounders such as age, baseline respiratory function, and pre-existing mental health conditions. | From enrollment to 4 weeks post-enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHIA CHI HSU | Contact | +8860960606032 | jiaqi92058@gmail.com |
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This study uses a parallel assignment design where participants are randomly allocated into either an intervention group receiving Passy-Muir speaking valves or a control group using conventional non-verbal communication methods. The effectiveness of the intervention is assessed through structured questionnaires measuring communication ability, depression levels, and quality of life over multiple time points. Data collectors remain blinded to group assignments to reduce bias in outcome assessments.
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| Standard Non-Verbal Communication Methods | Behavioral | This control group continues using conventional non-verbal communication methods such as gestures and lip-reading. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D003147 | Communication Disorders |
| D003863 | Depression |
| D003142 | Communication |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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