Augmented RealityNCT07012200
Effect of Immersive Interactive Nursing Guidance on Anxiety, Cognition, and Self-efficacy in CHD Patients Undergoing Cardiac Catheterization
A study testing Immersive Interactive Nursing Instruction and Routine Nursing Instructions in people with Augmented Reality and Nursing Education, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the effect of immersive interactive nursing guidance on anxiety, disease cognition, self-efficacy and satisfaction in patients undergoing cardiac catheterization for coronary heart disease. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Augmented Reality, Nursing Education, Anxiety
- What is being tested?
- Immersive Interactive Nursing Instruction and Routine Nursing Instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Mar 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 years or older with clear consciousness
- Diagnosed with coronary artery disease by a cardiologist and undergoing first-time cardiac catheterization or treatment
- Able to communicate in Mandarin or Taiwanese, and literate
Who cannot join
- Diagnosed with unstable coronary artery disease or acute myocardial infarction
- Requiring emergency cardiac catheterization or treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effect of Immersive Interactive Nursing Guidance on Anxiety, Cognition and Self-efficacy in Patients With Coronary Heart Disease Undergoing Cardiac Catheterization
The purpose of this study is to explore the effect of immersive interactive nursing guidance on anxiety, disease cognition, self-efficacy and satisfaction in patients undergoing cardiac catheterization for coronary heart disease. It will help clinical medical staff understand the timing and effectiveness of interventional immersive interactive nursing guidance for patients undergoing cardiac catheterization. Therefore, the research hypotheses to be verified in this study are as follows:
- There are differences in anxiety between patients receiving immersive interactive nursing guidance and traditional written medical education for cardiac catheterization.
- There are differences in disease cognition between patients receiving immersive interactive nursing guidance and traditional written health education for cardiac catheterization.
- There are differences in the self-efficacy of patients receiving immersive interactive nursing guidance and traditional written medical education for cardiac catheterization.
- There are differences in the satisfaction with the use of immersive interactive nursing guidance.
Read the detailed description
The subjects of this study are patients who received cardiac catheterization for the first time. The experimental study was conducted with a single-blind study design. The experimental group used immersive interactive nursing guidance and the control group used general nursing guidance to conduct a comparative study of different nursing guidance before discharge. . The researcher first makes a random admission form. For those who meet the research admission conditions, the researcher first gives an explanation, obtains the patient's consent and signs the consent form for the human experiment, and assigns the research cases to the experimental group and the control group according to random acceptance. A structured questionnaire was used to investigate the differences in the degree of improvement in anxiety, cognition and self-efficacy of patients with coronary heart disease before they were discharged from the hospital after cardiac catheterization. After filling in the basic information on the day of admission, the patient began to fill in the pre-test questionnaires: "Situation and Trait Anxiety Scale", "Cognition Scale", and "Self-Efficacy Scale". After the pre-test questionnaires were collected, the experimental group received immersive interactive nursing guidance in addition to general routine nursing guidance (general routine nursing health education leaflets, combined with oral health education and key explanations, talks and consultations), which included : 360-degree introduction to the environment of the cardiac catheterization laboratory, cardiac catheterization process (including preoperative, intraoperative, and postoperative), wound care, precautions for home care (including diet, medicine, and exercise), and nursing guidance content about 12-15 minutes long , can be watched by mobile phone or tablet, and can be watched repeatedly and experience interactive nursing guidance according to the patient's needs. The two groups of patients completed the "Situation and Trait Anxiety Scale (Post-test)" after nursing guidance and before performing cardiac catheterization; it did not affect the patient's rest, stable condition and completion of the "Cognitive Scale (Post-test)" and "Self-Test Scale" before discharge. Efficacy Scale (Post-test)" and Satisfaction Questionnaire.
- Conditions
- Augmented Reality, Nursing Education, Anxiety, Immersive
- Being tested
- Immersive Interactive Nursing Instruction, Routine Nursing Instructions
- Keywords
- cardiac catheterization, immersive Interactive, Nursing Guidance
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Interactive Nursing InstructionOther
360-degree introduction to the environment of the cardiac catheterization laboratory, cardiac catheterization procedures (including preoperative, intraoperative, and postoperative), wound care, and precautions for home care (including diet, medication, and exercise)
Routine Nursing InstructionsOther
Health education by talking and leaflets and key explanations, and providing talks and consultations
| Study group | Role | What they receive |
|---|---|---|
| Immersive Interactive Nursing Instruction | Experimental | Immersive interactive nursing guidance, which includes: 360-degree introduction to the environment of the cardiac catheterization laboratory, cardiac catheterization procedures (including preoperative, intraoperative, and postoperative), wound care, and precautions for home care (including diet, medication, and exercise) Receives: Other: Immersive Interactive Nursing Instruction |
| Routine Nursing Instructions | Active comparator | Health education by talking and leaflets and key explanations, and providing talks and consultations Receives: Other: Routine Nursing Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety index
Situation and Trait Anxiety Inventory,Score range 20-80 points,Higher scores indicate higher levels of anxiety.
Measured: within 24 hours after admission and prior to catheterization
cognitions
Self-made cardiac catheterization cognition questionnaire, the scale includes what is cardiac catheterization, complications, precautions for cardiac catheterization, drug use, social activities, daily care, etc. The higher the score, the higher the awareness
Measured: within 24 hours after admission and prior to catheterization
Self-efficacy
General Self-Efficacy Scale,10 items, each item is scored with 1 point for completely incorrect, 2 points for somewhat correct, 3 points for most correct, 4 points for completely correct, the higher the score, the higher the self-efficacy
Measured: within 24 hours after admission and prior to catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start21 Mar 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Why it stopped: The study was terminated due to reduced bed capacity in the cardiology ward, insufficient nursing manpower, hospital accreditation preparation, and exhaustion of platform budget. 112 participants were recruited; final analysis included 108.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Augmented RealityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012200
- Sponsor's protocol ID
- 111-208-E
- Status last verified
- Mar 2024
- First submitted
- 27 Aug 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Immersive Interactive Nursing Guidance on Anxiety, Cognition and Self-efficacy in Patients With Coronary Heart Disease Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT07012200
- Acronym / sponsor ID
- 111-208-E
- Conditions
- Augmented Reality, Nursing Education, Anxiety, Immersive
- Keywords
- cardiac catheterization, immersive Interactive, Nursing Guidance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to reduced bed capacity in the cardiology ward, insufficient nursing manpower, hospital accreditation preparation, and exhaustion of platform budget. 112 participants were recruited; final analysis included 108.
- Enrolment
- 108 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 10 Jun 2025 (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 purpose of this study is to explore the effect of immersive interactive nursing guidance on anxiety, disease cognition, self-efficacy and satisfaction in patients undergoing cardiac catheterization for coronary heart disease. It will help clinical medical staff understand the timing and effectiveness of interventional immersive interactive nursing guidance for patients undergoing cardiac catheterization. Therefore, the research hypotheses to be verified in this study are as follows:
- There are differences in anxiety between patients receiving immersive interactive nursing guidance and traditional written medical education for cardiac catheterization.
- There are differences in disease cognition between patients receiving immersive interactive nursing guidance and traditional written health education for cardiac catheterization.
- There are differences in the self-efficacy of patients receiving immersive interactive nursing guidance and traditional written medical education for cardiac catheterization.
- There are differences in the satisfaction with the use of immersive interactive nursing guidance.
Detailed description
The subjects of this study are patients who received cardiac catheterization for the first time. The experimental study was conducted with a single-blind study design. The experimental group used immersive interactive nursing guidance and the control group used general nursing guidance to conduct a comparative study of different nursing guidance before discharge. . The researcher first makes a random admission form. For those who meet the research admission conditions, the researcher first gives an explanation, obtains the patient's consent and signs the consent form for the human experiment, and assigns the research cases to the experimental group and the control group according to random acceptance. A structured questionnaire was used to investigate the differences in the degree of improvement in anxiety, cognition and self-efficacy of patients with coronary heart disease before they were discharged from the hospital after cardiac catheterization. After filling in the basic information on the day of admission, the patient began to fill in the pre-test questionnaires: "Situation and Trait Anxiety Scale", "Cognition Scale", and "Self-Efficacy Scale". After the pre-test questionnaires were collected, the experimental group received immersive interactive nursing guidance in addition to general routine nursing guidance (general routine nursing health education leaflets, combined with oral health education and key explanations, talks and consultations), which included : 360-degree introduction to the environment of the cardiac catheterization laboratory, cardiac catheterization process (including preoperative, intraoperative, and postoperative), wound care, precautions for home care (including diet, medicine, and exercise), and nursing guidance content about 12-15 minutes long , can be watched by mobile phone or tablet, and can be watched repeatedly and experience interactive nursing guidance according to the patient's needs. The two groups of patients completed the "Situation and Trait Anxiety Scale (Post-test)" after nursing guidance and before performing cardiac catheterization; it did not affect the patient's rest, stable condition and completion of the "Cognitive Scale (Post-test)" and "Self-Test Scale" before discharge. Efficacy Scale (Post-test)" and Satisfaction Questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Interactive Nursing Instruction | Experimental | Other: Immersive Interactive Nursing InstructionImmersive interactive nursing guidance, which includes: 360-degree introduction to the environment of the cardiac catheterization laboratory, cardiac catheterization procedures (including preoperative, intraoperative, and postoperative), wound care, and precautions for home care (including diet, medication, and exercise) |
| Routine Nursing Instructions | Active comparator | Other: Routine Nursing InstructionsHealth education by talking and leaflets and key explanations, and providing talks and consultations |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20 years or older with clear consciousness
- Diagnosed with coronary artery disease by a cardiologist and undergoing first-time cardiac catheterization or treatment
- Able to communicate in Mandarin or Taiwanese, and literate
Key exclusion criteria (2 listed)
- Diagnosed with unstable coronary artery disease or acute myocardial infarction
- Requiring emergency cardiac catheterization or treatment
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 |
|---|---|---|
| Immersive Interactive Nursing Instruction360-degree introduction to the environment of the cardiac catheterization laboratory, cardiac catheterization procedures (including preoperative, intraoperative, and postoperative), wound care, and precautions for home care (including diet, medication, and exercise) | Other | Immersive Interactive Nursing Instruction |
| Routine Nursing InstructionsHealth education by talking and leaflets and key explanations, and providing talks and consultations | Other | Routine Nursing Instructions |
Primary outcome
anxiety index
Time frame: within 24 hours after admission and prior to catheterization
Situation and Trait Anxiety Inventory,Score range 20-80 points,Higher scores indicate higher levels of anxiety.
cognitions
Time frame: within 24 hours after admission and prior to catheterization
Self-made cardiac catheterization cognition questionnaire, the scale includes what is cardiac catheterization, complications, precautions for cardiac catheterization, drug use, social activities, daily care, etc. The higher the score, the higher the awareness
Self-efficacy
Time frame: within 24 hours after admission and prior to catheterization
General Self-Efficacy Scale,10 items, each item is scored with 1 point for completely incorrect, 2 points for somewhat correct, 3 points for most correct, 4 points for completely correct, the higher the score, the higher the self-efficacy
Results and safety
The study was stopped early (reason given: The study was terminated due to reduced bed capacity in the cardiology ward, insufficient nursing manpower, hospital accreditation preparation, and exhaustion of platform budget. 112 participants were recruited; final analysis included 108.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Interactive Nursing Instruction and Routine Nursing Instructions in people with Augmented Reality and Nursing Education, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 10 Jun 2025. 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 Taiwan. 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?
The study was stopped early (reason given: The study was terminated due to reduced bed capacity in the cardiology ward, insufficient nursing manpower, hospital accreditation preparation, and exhaustion of platform budget. 112 participants were recruited; final analysis included 108.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety index (time frame: within 24 hours after admission and prior to catheterization). The study lists 3 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 10 Jun 2025.