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

NCT07362901 | Not Yet Recruiting

• 1 other identifier: IIT20250170C-R1
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Nursing care; Postoperative complication management

Outcome Measures

Primary Outcomes (6)

• Immobilization-Related Score

  The immobilization-related score is used to assess the degree of discomfort resulting from limb immobilization implemented for medical purposes. Major symptoms include lower back soreness, lower back pain, back soreness, and back pain. The score ranges from 1 to 10, with higher scores indicating more severe immobilization-related discomfort.

  Perioperative

• Puncture Site-Related Score

  The puncture site-related score is used to evaluate the degree of discomfort at and around the puncture site following transfemoral endovascular intervention. Main manifestations include pain around the puncture site, local erythema, and puncture site-related pseudoaneurysm, hematoma, or bleeding. The score ranges from 1 to 10, with higher scores indicating more severe puncture site-related discomfort.

  perioperative

• Medical Adhesive-Related Skin Injury (MARSI) Score

  The MARSI score is used to assess the severity of adverse skin reactions caused by the use of medical adhesive products or devices (e.g., catheter fixation tapes, dressings, compression bandages). Manifestations include blistering, skin breakdown, pain, erythema, and pruritus. The score ranges from 1 to 10, with higher scores indicating more severe skin injury.

  perioperative

• Aortic Disease-Related Score

  The aortic disease-related score is used to evaluate the degree of discomfort following endovascular aortic repair attributable to surgical manipulation, implanted devices (e.g., stents or stent grafts), or the progression of aortic pathology itself. Main symptoms include chest tightness or discomfort, chest or back pain, abdominal distension, and abdominal pain. The score ranges from 1 to 10, with higher scores indicating more severe aortic disease-related discomfort.

  perioperative

• Self-Care Ability-Related Score

  Based on Orem's self-care theory, the self-care ability-related score is used to assess the extent of impaired self-care resulting from physiological, psychological, or social limitations. Major aspects include difficulty with dressing and personal hygiene, restricted toileting in bed, impaired eating or drinking, inability to turn over independently, and negative impact on personal social image. The score ranges from 1 to 10, with higher scores indicating more severe self-care ability impairment.

  perioperative

• Psychosomatic Stress-Related Score

  The psychosomatic stress-related score is used to assess the severity of psychosomatic stress responses induced by internal or external stressors such as disease, trauma, or psychological pressure. Manifestations mainly include sleep disturbances, fear of movement due to excessive concern about puncture site or wound bleeding, and excessive sweating beyond usual levels. The score ranges from 1 to 10, with higher scores indicating more severe psychosomatic stress.

  perioperative

Secondary Outcomes (3)

• Length of hospital stay

  perioperative

• Patient satisfaction score

  perioperative

• Observation of complications

  perioperative

Study Arms (2)

1

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

Behavioral: postoperative precise education

2

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

Interventions

postoperative precise education BEHAVIORAL

Whether to implement precise education

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic dissection undergoing endovascular treatment

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Central Study Contacts

Peier Shen

CONTACT

+8613588040680; 405496770@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 23, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)