Aortic Dissection AneurysmNCT07362901
Effects of Precise Education on Postoperative Discomfort Symptoms in Patients With Aortic Disease Undergoing Endovascular Intervention: a Single-center Randomized Controlled Study
An observational study of Aortic Dissection Aneurysm and Aortic Dissection Rupture, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Dissection Aneurysm, Aortic Dissection Rupture, Aortic Dissection Involving the Descending Thoracic Aorta
- What is being tested?
- postoperative precise education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with aortic dissection undergoing endovascular treatment
Who may be able to join
- Diagnosed with thoracoabdominal aortic disease
- Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After
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.
Read the 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.
- Conditions
- Aortic Dissection Aneurysm, Aortic Dissection Rupture, Aortic Dissection Involving the Descending Thoracic Aorta
- Being tested
- postoperative precise education
- Keywords
- Nursing care, Postoperative complication management
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative precise educationBehavioural
Whether to implement precise education
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: perioperative
Secondary outcomes (3)
Length of hospital stay
Length of hospital stay from admission to discharge
Measured: perioperative
Patient satisfaction score
Patient satisfaction score ranges from 1 to 10, with higher scores indicating greater patient satisfaction.
Measured: perioperative
Observation of complications
Incidence of inguinal puncture site bleeding, hematoma, and pseudoaneurysm
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection AneurysmStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362901
- Sponsor's protocol ID
- IIT20250170C-R1
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Discomfort Symptoms in Patients With Aortic Disease After
- ClinicalTrials.gov ID
- NCT07362901
- Acronym / sponsor ID
- IIT20250170C-R1
- Conditions
- Aortic Dissection Aneurysm, Aortic Dissection Rupture, Aortic Dissection Involving the Descending Thoracic Aorta
- Keywords
- Nursing care, Postoperative complication management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: postoperative precise educationPatients 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 |
| 2 | – | –Routine nursing education involves distributing illustrated manuals to explain surgical procedures, pain management, early mobilization, preoperative preparations, and other relevant topics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with aortic dissection undergoing endovascular treatment
Key inclusion criteria (2 listed)
- Diagnosed with thoracoabdominal aortic disease
- Patients who underwent endovascular treatment of the thoracoabdominal aorta via the femoral artery approach
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postoperative precise educationWhether to implement precise education | Behavioural | 1 |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Length of hospital stay
Time frame: perioperative
Patient satisfaction score
Time frame: perioperative
Observation of complications
Time frame: perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection Aneurysm and Aortic Dissection Rupture, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peier Shen (+8613588040680, 405496770@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immobilization-Related Score (time frame: Perioperative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.