Pain, Anxiety, and Comfort Levels in Coronary Angiography | NCT06266117

Studies
Pain, Anxiety, and Comfort Levels in Coronary Angiography

NCT06266117

Sponsor

Abant Izzet Baysal University

Status

Unknown status

Last Update Posted

Feb 20, 2024Actual

Enrollment

216Estimated

Phase

Not provided

Conditions

Pain
Anxiety
Nursing Caries

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2024Estimated

Primary Completion Date

Mar 30, 2024Estimated

Completion Date

Jul 30, 2024Estimated

First Submitted Date

Feb 12, 2024

First Submission Date that Met QC Criteria

Feb 12, 2024

First Posted Date

Feb 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2024

Last Update Posted Date

Feb 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

216Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain level	Visual Pain Scale	on the 1st postoperative days
Anxiety	State/Trait Anxiety Scale	on the 1st postoperative days
Comfort	Perianesthesia Comfort Scale	on the 1st postoperative days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over 18 years Conscious patients

Exclusion Criteria:

Patients undergoing intubation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing coronary angiography in the coronary intensive care unit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Muhammed Nur ÖGÜN	Contact	090 374 253 46 56		muhammed.ogun@ibu.edu.tr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abant Izzet Baysal University Faculty of Health Science		Bolu	Merkez	14100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40516941	Derived	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.

ID	Term
D010146	Pain
D001008	Anxiety Disorders

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders