Effect of Preoperative Individualized Education on Anxiety and Recovery.

Education Clinical Trial

Official title:

Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419088
• Other study ID #: EPIEAR
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Fujian Medical University Union Hospital
• Contact: Maohui Chen, Prof
• Phone: 18659181171
• Email: 757860733[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers aim to investigate whether individualized preoperative education for patients is beneficial in reducing perioperative anxiety, promoting postoperative recovery, and enhancing postoperative quality of life. The educational content will cover aspects such as the surgery procedure, anesthesia, postoperative pain and anxiety management, recovery time, and any potential required treatments. All participants will be administered a questionnaire before the surgery to evaluate their specific concerns and fears. The intervention group will receive preoperative education through audio-visual materials followed by targeted preoperative counseling, while the control group will receive routine preoperative education.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged 18 or above;

2. Received single-port thoracoscopic surgery;

3. Volunteered to participate in the study and signed an informed consent form.

Exclusion Criteria:

1. Presence of a mental disorder

2. Preoperative pain

3. Pregnancy

4. Presence of other tumours requiring treatment.

Related Conditions & MeSH terms

• Education

Intervention

Other:
• Preoperative individualized education
Based on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety status	Change in anxiety intensity scores	Before and after education, 12 months after surgery
Primary	Postoperative pain	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
Primary	Postoperative nausea and vomiting	The Visual Analog Scale (VAS) was used to evaluate the intensity of nausea and vomiting	Baseline, postoperative days 1,2,3
Primary	Sleep disorders	Change in Athens Insomnia Scale	Baseline, postoperative days 1,2,3
Secondary	Postoperative Complications	The incidence of common postoperative complications	12 months after surgery
Secondary	Quality of life 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