Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-27 @ 8:13 PM
Study NCT ID:
NCT05539092
Status:
UNKNOWN
Last Update Posted:
2022-09-14
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Changing Angle of Bed on Pain Severity and Vascular Complications Among Cardiac Catheterization Patients
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Faculty of Nursing- Critical Care and Emergency Nursing Department
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. In 2019, approximately 18.6 million deaths were attributed to CVD globally. As a consequence, cardiac catheterization remains the criterion standard for evaluation of CAD.
Detailed Description:
This study will be conducted in three phases; preparation, implementation, and evaluation.
1. Preparation phase
* Ethical approval will be obtained from the Research Ethics Committee (REC) of the Faculty of Nursing - Mansoura University.
* Content validity of the developed tool will be reviewed by a jury of five experts in the study field and the suggestions of the jury members will be considered.
* The reliability of this tool will be assessed also by using Cronbach's Alpha Test.
2. Implementation phase
* An initial assessment will be carried out for all patients to confirm that they are free from the exclusion criteria.
* Patients will be assigned into two groups: intervention group and control group, 41 patients for each group.
* Before the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission using part I and part II of tool I.
* In both groups after cardiac catheterization procedure: the sheath will be removed immediately by the nurse.
* In the control group: positioning the patients in supine for 6 hours and the affected leg was straight and immobilized.
* In the intervention group: the researcher will change angle of bed from 15° to 45°.
* The severity of pain will be assessed by using part III of tool I for five times starting immediately after sheath removal.
* Vascular complications monitoring scales will be assessed by using tool III for five times starting immediately after sheath removal.
3. Evaluation phase This phase aims to investigate the effect of changing angle of bed on pain severity and vascular complications for both groups.
1. Preparation phase
* Ethical approval will be obtained from the Research Ethics Committee (REC) of the Faculty of Nursing - Mansoura University.
* Content validity of the developed tool will be reviewed by a jury of five experts in the study field and the suggestions of the jury members will be considered.
* The reliability of this tool will be assessed also by using Cronbach's Alpha Test.
2. Implementation phase
* An initial assessment will be carried out for all patients to confirm that they are free from the exclusion criteria.
* Patients will be assigned into two groups: intervention group and control group, 41 patients for each group.
* Before the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission using part I and part II of tool I.
* In both groups after cardiac catheterization procedure: the sheath will be removed immediately by the nurse.
* In the control group: positioning the patients in supine for 6 hours and the affected leg was straight and immobilized.
* In the intervention group: the researcher will change angle of bed from 15° to 45°.
* The severity of pain will be assessed by using part III of tool I for five times starting immediately after sheath removal.
* Vascular complications monitoring scales will be assessed by using tool III for five times starting immediately after sheath removal.
3. Evaluation phase This phase aims to investigate the effect of changing angle of bed on pain severity and vascular complications for both groups.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: