Effect of Preoperative Individualized Education on Anxiety and Recovery.

NCT ID: NCT06419088

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2026-03-30

Brief 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.

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.

Conditions

Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

individualized education group

received individualized educational interventions utilizing audiovisual materials

Group Type: OTHER

Preoperative individualized education

Intervention Type: OTHER

Based on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward.

standard education group

only routine preoperative education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Preoperative individualized education

Based on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun Chen, Prof

Role: STUDY_CHAIR

Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

EPIEAR

Identifier Type: -

Identifier Source: org_study_id