The Effect of Changing Angle of Bed on Pain Severity and Vascular Complications Among Cardiac Catheterization Patients

NCT05539092 | Unknown

• 1 other identifier: Ref.no.p 0.0237
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Catheterization

Outcome Measures

Primary Outcomes (1)

• changing pain severity according to the numerical pain scale

  Patients who receive changing angle of bed after cardiac catheterization will have less pain severity according to the numerical pain scale than those who will receive hospital routine care.

  6 hours

Secondary Outcomes (1)

• reduction of vascular complications according to the vascular complications monitoring scales

  6 hours

Study Arms (2)

intervention group

EXPERIMENTAL

the researcher will change angle of bed from 15° to 45°. The severity of pain will be assessed for five times starting immediately after sheath removal. Vascular complications monitoring scales will be assessed I for five times starting immediately after sheath removal.

Other: changing angle of bed

control group

NO INTERVENTION

positioning the patients in supine for 6 hours and the affected leg was straight and immobilized. The severity of pain will be assessed for five times starting immediately after sheath removal. Vascular complications monitoring scales will be assessed I for five times starting immediately after sheath removal.

Interventions

changing angle of bed OTHER

Before the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission. the researcher will change angle of bed from 15° to 45°.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient ≥ 18 years old of both sexes.
• Conscious patients admitted to the CCU after diagnostic or therapeutic cardiac catheterization.
• Patients who will have femoral artery catheterization.
• Patients who will have normal prothrombin time and partial thromboplastin time.

You may not qualify if:

• Patients who have previous surgery in the iliac or femoral artery.
• Patients who have chronic back pain.
• Patients who have an active bleed¬ing, hematoma and ecchymosis from insertion site prior to the sheath withdrawal.
• Patient who take anti-coagulant drugs and analgesic therapy within the previous 24 hours before the procedure.

Sponsors & Collaborators

• Mansoura University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 14, 2022
• Study Start: September 30, 2022
• Primary Completion: January 30, 2023
• Study Completion: February 28, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-08