- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388225
The Effect of Preoperative Education on Recovery of Thoracic Surgery Patients
Brief Summary
This randomized controlled study evaluated the effect of structured preoperative education on postoperative recovery outcomes in patients undergoing thoracic surgery for lung cancer. The study was conducted in a tertiary public hospital in Istanbul between June 2022 and December 2023 and included 100 adult patients who met the inclusion criteria. Participants were randomly assigned to an intervention group or a control group.
Patients in the intervention group received structured, nurse-led preoperative education supported by a standardized patient education booklet, while the control group received routine hospital care. Recovery outcomes were assessed using physiological parameters, pulmonary function tests, shoulder joint range of motion measurements, pain intensity scores, and the Quality of Recovery-40 (QoR-40) questionnaire during the early postoperative period.
The findings of this study aim to contribute evidence on the role of preoperative nursing education in improving functional recovery, reducing postoperative pain, and supporting respiratory function in patients undergoing thoracic surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detailed Description
Thoracic surgery for lung cancer is associated with significant postoperative pain, reduced pulmonary function, limited shoulder mobility, and delayed functional recovery. These factors may negatively affect patient outcomes, prolong hospitalization, and increase the risk of postoperative complications. Preoperative education is considered a key nursing intervention that may enhance patients' physical and psychological preparedness for surgery and improve postoperative recovery.
This randomized controlled experimental study was conducted in the thoracic surgery units of a tertiary public hospital in Istanbul. A total of 100 patients scheduled for elective thoracic surgery due to lung cancer were enrolled and randomly assigned to either the intervention group (n=50) or the control group (n=50). Randomization was performed using a computer-generated randomization method.
Patients in the control group received standard preoperative and postoperative care routinely provided by the hospital. Patients in the intervention group received structured preoperative education delivered by a nurse, supported by a standardized patient education booklet. The education included information on the surgical procedure, breathing and coughing exercises, use of incentive spirometry, early ambulation, shoulder and upper extremity exercises, and pain management strategies.
Data were collected at three time points: preoperatively, on postoperative day 1, and on postoperative day 4. Outcome measures included pulmonary function tests (FEV1 and FVC), shoulder joint range of motion assessed by goniometry, pain intensity measured using the Visual Analog Scale (VAS), and recovery quality evaluated using the Quality of Recovery-40 (QoR-40) questionnaire. Vital signs and oxygen saturation levels were also recorded.
The primary objective of the study was to determine whether structured preoperative education improves postoperative recovery outcomes compared to routine care. Secondary objectives included evaluating the effects of education on pain levels, pulmonary function, shoulder mobility, and quality of recovery.
The results of this study are expected to provide evidence supporting the integration of structured preoperative nursing education into clinical care protocols for patients undergoing thoracic surgery, with the goal of improving functional recovery and patient-centered outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
başakşehir
-
Istanbul, başakşehir, Turkey (Türkiye), 34480
- Basaksehir Cam and Sakura City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with lung cancer who are hospitalized for elective thoracic surgery
- Aged 18 years and older
- Able to read, write, and speak Turkish
- Able to understand the information provided and without any condition that interferes with verbal communication
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients scheduled for lung resection via thoracotomy
- Patients undergoing surgery under general anesthesia
Exclusion Criteria:
- Patients with chronic pain in the preoperative period who are using analgesic medications for pain management
- Patients receiving antineoplastic treatment
- Patients undergoing reoperation due to lung cancer
- Patients with an ECOG performance status greater than 2
- Patients diagnosed with metastatic lung cancer
- Patients with limited mobility in the preoperative period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group: Structured Preoperative Education
Participants assigned to this arm receive structured, nurse-led preoperative education in addition to routine hospital care prior to thoracic surgery.
|
A structured, nurse-led preoperative education program delivered prior to thoracic surgery.
|
|
Active Comparator: Control Group: Routine Care
Participants assigned to this arm receive standard preoperative and postoperative care routinely provided by the hospital.
|
Standard care routinely provided by the hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Recovery Quality
Time Frame: Postoperative day 1 and postoperative day 4
|
Postoperative recovery quality assessed using the Quality of Recovery-40 (QoR-40) questionnaire.
The total score ranges from 40 to 200, with higher scores indicating better recovery quality.
|
Postoperative day 1 and postoperative day 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
Time Frame: Preoperative period, postoperative day 1, and postoperative day 4
|
Pain intensity assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate worse pain.
|
Preoperative period, postoperative day 1, and postoperative day 4
|
|
Pulmonary Function
Time Frame: Preoperative period, postoperative day 1, and postoperative day 4
|
Pulmonary function assessed using forced expiratory volume in one second (FEV1) and forced vital capacity (FVC), measured in liters.
|
Preoperative period, postoperative day 1, and postoperative day 4
|
|
Shoulder Joint Range of Motion
Time Frame: Preoperative period, postoperative day 1, and postoperative day 4
|
Shoulder joint range of motion measured using a goniometer and expressed in degrees.
Higher values indicate better functional outcome.
|
Preoperative period, postoperative day 1, and postoperative day 4
|
|
Postoperative Heart Rate
Time Frame: Preoperative period, postoperative day 1, and postoperative day 4
|
Heart rate measured in beats per minute (bpm).
Higher values indicate a worse outcome.
|
Preoperative period, postoperative day 1, and postoperative day 4
|
|
Postoperative Blood Pressure
Time Frame: Preoperative period, postoperative day 1, and postoperative day 4
|
Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg).
Higher values indicate a worse outcome.
|
Preoperative period, postoperative day 1, and postoperative day 4
|
|
Postoperative Respiratory Rate
Time Frame: Preoperative period, postoperative day 1, and postoperative day 4
|
Respiratory rate measured as breaths per minute.
Higher values indicate a worse outcome.
|
Preoperative period, postoperative day 1, and postoperative day 4
|
|
Postoperative Oxygen Saturation
Time Frame: Preoperative period, postoperative day 1, and postoperative day 4
|
Peripheral oxygen saturation measured by pulse oximetry and expressed as percentage (%).
Higher values indicate a better outcome.
|
Preoperative period, postoperative day 1, and postoperative day 4
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- THORACIC-EDU-RECOVERY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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