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

Mansoura University

Status: Not yet enrolling

Conditions: Cardiac Catheterization

Treatments: Other: changing angle of bed

Study type: Interventional

Funder types: Other

Identifiers

NCT05539092

Ref.no.p 0.0237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

intervention group

Experimental group

Description:

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.

Treatment:

Other: changing angle of bed

control group

No Intervention group

Description:

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.