EducationNCT06419088
Effect of Preoperative Individualized Education on Anxiety and Recovery.
A study testing Preoperative individualized education in people with Education, run by Fujian Medical University Union Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Education
- What is being tested?
- Preoperative individualized education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or above;
- Received single-port thoracoscopic surgery;
- Volunteered to participate in the study and signed an informed consent form.
Who cannot join
- Presence of a mental disorder
- Preoperative pain
- Pregnancy
- Presence of other tumours requiring treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery
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.
Read the 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
- Being tested
- Preoperative individualized education
- Keywords
- Preoperative education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative individualized educationOther
Based on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward.
| Study group | Role | What they receive |
|---|---|---|
| individualized education group | Other | received individualized educational interventions utilizing audiovisual materials Receives: Other: Preoperative individualized education |
| standard education group | No intervention | only routine preoperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety status
Change in anxiety intensity scores
Measured: Before and after education, 12 months after surgery
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.
Measured: Baseline, postoperative days 1,2,3
Postoperative nausea and vomiting
The Visual Analog Scale (VAS) was used to evaluate the intensity of nausea and vomiting
Measured: Baseline, postoperative days 1,2,3
Sleep disorders
Change in Athens Insomnia Scale
Measured: Baseline, postoperative days 1,2,3
Secondary outcomes (2)
Postoperative Complications
The incidence of common postoperative complications
Measured: 12 months after surgery
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.
Measured: Baseline, 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start30 May 2024
- Primary completion25 Nov 2025
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Chen, Prof, Study chair, Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419088
- Sponsor's protocol ID
- EPIEAR
- Status last verified
- Nov 2025
- First submitted
- 14 May 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery
- ClinicalTrials.gov ID
- NCT06419088
- Acronym / sponsor ID
- EPIEAR
- Conditions
- Education
- Keywords
- Preoperative education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individualized education group | Other | Other: Preoperative individualized educationreceived individualized educational interventions utilizing audiovisual materials |
| standard education group | No intervention | –only routine preoperative education |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or above;
- Received single-port thoracoscopic surgery;
- Volunteered to participate in the study and signed an informed consent form.
Key exclusion criteria (4 listed)
- Presence of a mental disorder
- Preoperative pain
- Pregnancy
- Presence of other tumours requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative individualized educationBased on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward. | Other | individualized education group |
Primary outcome
Anxiety status
Time frame: Before and after education, 12 months after surgery
Change in anxiety intensity scores
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.
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
Sleep disorders
Time frame: Baseline, postoperative days 1,2,3
Change in Athens Insomnia Scale
2 secondary outcomes
Postoperative Complications
Time frame: 12 months after surgery
Quality of life after surgery
Time frame: Baseline, 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Chen, Prof study chair
Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative individualized education in people with Education, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety status (time frame: Before and after education, 12 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.