- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06419088
Effect of Preoperative Individualized Education on Anxiety and Recovery.
Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who met the research criteria were consulted prior to surgery, during which the research objectives were explained, and written consent was obtained. Following baseline assessment, patients were randomly allocated to either the individualized education group or the routine education group. Sociodemographic information was collected through face-to-face interviews conducted in the ward. Additionally, levels of anxiety and adverse events (sleep, pain, nausea, vomiting) were measured using the Visual Analog Scale (VAS) and Hospital Anxiety and Depression Scale (HADS). Patient anxieties regarding different aspects were assessed using specific concerns and fears scales.
The intervention group received individualized educational interventions utilizing audiovisual materials. Based on identified personalized educational needs, researchers administered individualized preoperative education to the intervention group in the ward. Patients in the control group received only routine preoperative education from clinical nurses.
The second assessment was conducted before patients were transferred to the operating room. Anxiety levels and adverse events (preoperative sleep, pain, nausea, and vomiting) were assessed using HADS and VAS. Postoperatively, pain, nausea, vomiting, and coughing were evaluated three times daily for the first three days (every 8 hours) using the Visual Analog Scale (VAS), and sleep was assessed daily using the Athens Insomnia Scale (AIS). Chronic symptoms and quality of life were assessed at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough was evaluated using the Leicester Cough Questionnaire, and chronic pain was evaluated using the Brief Pain Inventory. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and HADS were used for continuous assessment of quality of life, anxiety, and depression status.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maohui Chen, Prof
- Phone Number: 18659181171
- Email: 757860733@qq.com
Study Contact Backup
- Name: Yizhou Huang
- Phone Number: 13959568242
- Email: 1204382231@qq.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350001
- Recruiting
- Fujian Medical University Union Hospital
-
Contact:
- Maohui Chen, Prof
- Phone Number: 18659181171
- Email: 757860733@qq.com
-
Contact:
- Yizhou Huang
- Phone Number: 13959568242
- Email: 1204382231@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 or above;
- Received single-port thoracoscopic surgery;
- Volunteered to participate in the study and signed an informed consent form.
Exclusion Criteria:
- Presence of a mental disorder
- Preoperative pain
- Pregnancy
- Presence of other tumours requiring treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: individualized education group
received individualized educational interventions utilizing audiovisual materials
|
Based on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward.
|
No Intervention: standard education group
only routine preoperative education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety status
Time Frame: Before and after education, 12 months after surgery
|
Change in anxiety intensity scores
|
Before and after education, 12 months after surgery
|
Postoperative pain
Time Frame: Baseline, postoperative days 1,2,3
|
The Visual Analog Scale (VAS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.
|
Baseline, postoperative days 1,2,3
|
Postoperative nausea and vomiting
Time Frame: Baseline, postoperative days 1,2,3
|
The Visual Analog Scale (VAS) was used to evaluate the intensity of nausea and vomiting
|
Baseline, postoperative days 1,2,3
|
Sleep disorders
Time Frame: Baseline, postoperative days 1,2,3
|
Change in Athens Insomnia Scale
|
Baseline, postoperative days 1,2,3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Complications
Time Frame: 12 months after surgery
|
The incidence of common postoperative complications
|
12 months after surgery
|
Quality of life after surgery
Time Frame: Baseline, 12 months after surgery
|
Change from baseline in quality of life scores on the European Organisation for Research and Treatment of Cancer 30 item Quality of Life Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.
|
Baseline, 12 months after surgery
|
Collaborators and Investigators
Investigators
- Study Chair: Chun Chen, Prof, Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EPIEAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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