PainNCT06266117
Pain, Anxiety, and Comfort Levels in Coronary Angiography
An observational study of Pain and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Anxiety, Nursing Caries
- How many people
- 216 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 30 Jul 2024
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing coronary angiography in the coronary intensive care unit
Who may be able to join
- over 18 years Conscious patients
Who cannot join
- Patients undergoing intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University Faculty of Health Science
Bolu, Merkez, 14100
About this study
Official title: Investigation of Factors Affecting Pain, Anxiety, and Comfort Levels in Patients Undergoing Coronary Angiography
The study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit.
Read the detailed description
In the first part, the descriptive information of the patients will be used, and in the second part, "Perianesthesia Comfort Scale", "State/Trait Anxiety Scale" and "General Comfort Scale (GAS)" adapted into Turkish by Üstündağ and Aslan in 2010 will be used. Visual Pain Scale will be used for pain measurement.
It is planned that the data for the Perianesthesia Comfort Scale (PCI) will be collected in the patient's room on the first postoperative day, in approximately 15 minutes, by face-to-face interview method.
- Conditions
- Pain, Anxiety, Nursing Caries
- Medical subject headings
- Pain, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Visual Pain Scale
Measured: on the 1st postoperative days
Anxiety
State/Trait Anxiety Scale
Measured: on the 1st postoperative days
Comfort
Perianesthesia Comfort Scale
Measured: on the 1st postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Other
- Time perspective
- Prospective
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266117
- Sponsor's protocol ID
- SBF-HMS-GES-03
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soysal GE, Demir Erbas S. Factors influencing pain, anxiety, and comfort in patients undergoing coronary angiography: A prospective observational study. Saudi Med J. 2025 Jun;46(6):679-687. doi: 10.15537/smj.2025.46.6.20240158.
PubMed 40516941
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Affecting Pain, Anxiety, and Comfort Levels in Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT06266117
- Acronym / sponsor ID
- SBF-HMS-GES-03
- Conditions
- Pain, Anxiety, Nursing Caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 20 Feb 2024 (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 study was designed as a descriptive study. The universe of the study is İzzet Baysal Training and Research Hospital; It consists of patients who underwent coronary angiography in the coronary intensive care unit.
Detailed description
In the first part, the descriptive information of the patients will be used, and in the second part, "Perianesthesia Comfort Scale", "State/Trait Anxiety Scale" and "General Comfort Scale (GAS)" adapted into Turkish by Üstündağ and Aslan in 2010 will be used. Visual Pain Scale will be used for pain measurement.
It is planned that the data for the Perianesthesia Comfort Scale (PCI) will be collected in the patient's room on the first postoperative day, in approximately 15 minutes, by face-to-face interview method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary angiography in the coronary intensive care unit
Key inclusion criteria (1 listed)
- over 18 years Conscious patients
Key exclusion criteria (1 listed)
- Patients undergoing intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain level
Time frame: on the 1st postoperative days
Visual Pain Scale
Anxiety
Time frame: on the 1st postoperative days
State/Trait Anxiety Scale
Comfort
Time frame: on the 1st postoperative days
Perianesthesia Comfort Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40516941Soysal GE, Demir Erbas S. Factors influencing pain, anxiety, and comfort in patients undergoing coronary angiography: A prospective observational study. Saudi Med J. 2025 Jun;46(6):679-687. doi: 10.15537/smj.2025.46.6.20240158.
- 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.
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 Pain and Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Nur ÖGÜN (090 374 253 46 56, muhammed.ogun@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: on the 1st postoperative days). 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?
On the ClinicalTrials.gov record for NCT06266117, which also lists 1 linked publication.
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 20 Feb 2024.