Effects of Precise Education on Postoperative Discomfort Symptoms in Patients With Aortic Disease Undergoing Endovascular Intervention: a Single-center Randomized Controlled Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: postoperative precise education.
- Who it may be relevant to
- Registry conditions: Aortic Dissection Aneurysm, Aortic Dissection Rupture, Aortic Dissection Involving the Descending Thoracic Aorta. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After
Overview
The incidence and severity of post-procedural discomfort were evaluated in patients undergoing endovascular repair for aortic dissection across six symptom-related dimensions: immobilization-related issues, puncture site discomfort, adhesive-induced skin reactions, post-stent implantation syndrome, impairment in self-care ability, and physical/psychological stress responses.
Detailed description
In this study, a customized postoperative discomfort symptom assessment questionnaire was developed based on patient-reported outcomes, with the objective of systematically evaluating common discomfort symptoms experienced by patients with aortic disease after endovascular intervention. The questionnaire covers six core dimensions: immobilization-related discomfort, puncture site-related discomfort, adhesive-related skin reactions, post-stent implantation syndrome, decline in self-care ability, and psychosomatic stress responses. Each symptom within these dimensions was scored on a 0-4 scale according to severity: 0 indicates no symptoms; 1 indicates mild symptoms that are tolerable; 2 indicates moderate symptoms that affect daily life but remain tolerable; 3 indicates severe symptoms requiring medical intervention; and 4 indicates extremely severe symptoms that are intolerable and require emergency treatment.
Pain was evaluated using the Numeric Rating Scale (NRS). Skin reactions such as lesions, blisters, bruises, erythema, and rashes were quantified by measuring the longest and widest dimensions of the lesion using a flexible measuring tape. Self-care ability was assessed using the Activities of Daily Living (ADL) scale combined with patient self-evaluation, focusing on four aspects: changing clothes, controlling bowel and bladder function, eating and drinking, and turning in bed.clothes, controlling bowel and bladder, eating and drinking, and turning in bed. Scoring ranged from 0 to 4, where 0 represented no impact, 1 represented mild impact, 2 indicated moderate impact (partial assistance needed but most activities completed independently), 3 indicated severe impact (major assistance needed, only a few activities independently completed), and 4 indicated almost complete loss of self-care ability.
Sleep disturbances were also rated from 0 to 4: 0 for no impact; 1 for mild disturbance with ability to fall asleep without special treatment; 2 for moderate disturbance, requiring a quiet environment to fall asleep; 3 for severe disturbance needing sleep medications; and 4 for complete inability to sleep. Abnormal sweating was similarly rated from 0 to 4: 0 for no sweating; 1 for slight perspiration; 2 for sweating in multiple areas such as armpits and back; 3 for soaked clothes or bed linens once; and 4 for soaking more than once.
Each discomfort dimension was clinically defined with clear inclusion criteria. Immobilization-related discomfort referred to symptoms resulting from postoperative limb immobilization, such as lower back soreness, which typically resolved after the immobilization was lifted. Puncture site-related discomfort was caused by pressure bandaging or sandbag compression, and included local pain, itching, bruising, erythema, or rash around the puncture site (excluding complications such as hematoma or pseudoaneurysm). Adhesive-related skin reactions included blisters, erosions, rashes, redness, itching, and bruising due to the use of pressure bandages or adhesive dressings.
Aortic disease-related discomfort symptoms included postoperative chest tightness, new chest or back pain different from the initial presentation, and abdominal bloating or pain (after excluding cardiovascular or gastrointestinal causes), which may be related to post-stent inflammatory responses or systemic stress. Decline in self-care ability referred to reduced independence compared to the preoperative state, including inability to change clothes independently, difficulty with toileting in bed, impaired eating or drinking, and inability to turn over in bed. Psychosomatic stress responses involved changes in psychological and physical states not present before surgery, such as sleep disturbances, fear of movement due to anxiety about puncture site bleeding, and profuse sweating.
Through this questionnaire, we aim to quantify patients' subjective discomfort from multiple dimensions in a systematic manner, providing a foundation for optimizing perioperative nursing interventions, improving patient comfort, and promoting enhanced recovery after endovascular treatment.
Interventions
- Behavioral postoperative precise education
Whether to implement precise education
Primary outcome measures
- Immobilization-Related Score [Time frame: Perioperative]
- Puncture Site-Related Score [Time frame: perioperative]
- Medical Adhesive-Related Skin Injury (MARSI) Score [Time frame: perioperative]
- Aortic Disease-Related Score [Time frame: perioperative]
- Self-Care Ability-Related Score [Time frame: perioperative]
- Psychosomatic Stress-Related Score [Time frame: perioperative]
Secondary outcome measures (3)
- Length of hospital stay [Time frame: perioperative]
- Patient satisfaction score [Time frame: perioperative]
- Observation of complications [Time frame: perioperative]
Eligibility criteria
Inclusion criteria
- Diagnosed with thoracoabdominal aortic disease
- Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach
Exclusion criteria
- Aortic disease caused by infection
- Aortic disease caused by trauma
- Aortic disease treated by open abdominal surgery
- Presence of systemic diseases uncontrollable by current medical standards (e.g., severe cardiac, pulmonary or hepatic dysfunction; advanced malignancy; cachexia; refractory severe coronary artery disease symptoms; coagulation disorders caused by genetic diseases, etc.)
- Patients who have undergone endovascular aortic treatment via femoral artery access prior to this procedure due to other diseases (not related to the current aortic disease)
- Patients with intracerebral hemorrhage, symptomatic stroke, myocardial infarction, or gastrointestinal bleeding within the past 6 months; patients under 18 years old; or those who refuse to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The first affiliated hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT07362901 · IIT20250170C-R1