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NCT Number: NCT07362901

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

postoperative precise education

Behavioral

Whether to implement precise education

Primary outcomes

  1. Immobilization-Related Score

    Time frame: Perioperative

    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.

  2. Puncture Site-Related Score

    Time frame: perioperative

    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.

  3. Medical Adhesive-Related Skin Injury (MARSI) Score

    Time frame: perioperative

    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.

  4. Aortic Disease-Related Score

    Time frame: perioperative

    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.

  5. Self-Care Ability-Related Score

    Time frame: perioperative

    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.

  6. Psychosomatic Stress-Related Score

    Time frame: perioperative

    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.

Secondary outcomes

  1. Length of hospital stay

    Time frame: perioperative

    Length of hospital stay from admission to discharge

  2. Patient satisfaction score

    Time frame: perioperative

    Patient satisfaction score ranges from 1 to 10, with higher scores indicating greater patient satisfaction.

  3. Observation of complications

    Time frame: perioperative

    Incidence of inguinal puncture site bleeding, hematoma, and pseudoaneurysm

Study contacts

Contact information is provided by the study sponsor or research team.

Peier Shen

CONTACT

[email protected]

+8613588040680

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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