Effects of Precise Education on Postoperative Discomfort Symptoms in Patients With Aortic Disease Undergoing Endovascular Intervention: a Single-center Randomized Controlled Study

Zhejiang University

Status: Not yet enrolling

Conditions: Aortic Dissection Involving the Descending Thoracic Aorta; Aortic Dissection Rupture; Aortic Dissection Aneurysm

Treatments: Behavioral: postoperative precise education

Study type: Observational

Funder types: Other

Identifiers

NCT07362901

IIT20250170C-R1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with thoracoabdominal aortic disease
2. Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach

Exclusion criteria

1. Aortic disease caused by infection
2. Aortic disease caused by trauma
3. Aortic disease treated by open abdominal surgery
4. 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.)
5. 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)
6. 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

Trial design

132 participants in 2 patient groups

1

Description:

Patients with a Precise patient education involves distributing illustrated manuals that explain the specific circumstances related to six dimensions: surgical procedures, pain management, early mobilization, preoperative preparations, and potential discomfort symptoms.ortic dissection who received endovascular treatment

Treatment:

Behavioral: postoperative precise education

2

Description:

Routine nursing education involves distributing illustrated manuals to explain surgical procedures, pain management, early mobilization, preoperative preparations, and other relevant topics.