Clinical trial NCT06419088: Effect of Preoperative Individualized Education on Anxiety and Recovery.
Official title: Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Education
Keywords: Preoperative education
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Anxiety status
timeFrame: Before and after education, 12 months after surgery
measure: Postoperative pain
timeFrame: Baseline, postoperative days 1,2,3
measure: Postoperative nausea and vomiting
timeFrame: Baseline, postoperative days 1,2,3
measure: Sleep disorders
timeFrame: Baseline, postoperative days 1,2,3
Secondary outcomes:
measure: Postoperative Complications
timeFrame: 12 months after surgery
measure: Quality of life after surgery
timeFrame: Baseline, 12 months after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu
name: Chun Chen, Prof
role: STUDY_CHAIR
References: