Effect of Position Change on Pain, Comfort and Vascular Complications After Coronary Angiography

Effect of Position Change on Pain, Comfort and Vascular Complications After Coronary Angiography: A Double-Blind Randomized Controlled Trial

Today, complementary and alternative treatments are frequently used to maintain health and well-being, reduce symptoms of diseases, and provide relaxation. Nurses contribute to the healing process by using pharmacological and nonpharmacological methods. Pharmacological methods cause nausea, vomiting, respiratory depression, gastrointestinal and urinary system complications in individuals. Therefore, nonpharmacological methods without side effects are gaining importance. Nonpharmacological methods are easy and simple nursing interventions that do not have side effects, are cost-effective, can be easily taught to the patient, reduce pain and anxiety. They can also be used in addition to pharmacological methods and are preferred in patients who do not take medication or are unwilling to take medication. Providing a safe position without vascular complications and back pain after the procedure is very important for both the patient and the nurse who cares for the patient. Existing studies on post-intervention position changes have reported low incidences of bleeding and back pain, resulting in higher levels of patient comfort and satisfaction. These studies evaluated different angles of elevating the head of the bed and recommended further studies to evaluate the possibility of shifting patients to other positions after transfemoral cardiac interventions.

Study Overview

• Status: Completed
• Conditions: Pain; Angiopathy, Peripheral
• Intervention / Treatment: Other: The bed levels of the patients in the experimental group changed the patient's position

Detailed Description

Therefore, the aim of this study was to investigate the effect of position change after coronary angiography on pain, comfort and vascular complications.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kütahya, Turkey (Türkiye), 43000
    • Necibe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years of age

  • Agree to participate in the study
  • Not undergoing emergency coronary angiography
  • Not consuming coffee or hypnotic drugs at least 12 hours ago
  • No history of chronic pain (e.g. arthritis)
  • Not addicted to alcohol or drugs
  • No psychological problems (such as depression, anxiety disorder)
  • Not using anxiolytics

Exclusion Criteria:

• • Not willing to participate in the study

  • Developing delirium during the follow-up period
  • Developing complications after coronary angiography (such as bleeding etc.)
  • Arrhythmia
  • Hemodynamic instability
  • Hereditary bleeding disorders
  • Platelet count less than 100,000/mm3
  • Abnormal coagulation parameters (high INR and/or aPTT)
  • History of percutaneous coronary intervention (PCI)
  • Multiple or bilateral punctures in the femoral artery
  • Presence of hematoma on arrival after the procedure
  • Radial access
  • Bleeding at the access site or at the access dressing site
  • Body mass index (BMI) ≥ 35 kg/m2
  • Back pain before treatment
  • Patients with spinal cord disease
  • Patients with vertebral disc disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: back position group; The bed levels of the patients in the experimental group changed the patient's position every 2 hours immediately after catheter removal and sandbag placement in the following order: supine position with a 15° head angle, semi-Fowler position with a 30° head angle, and lateral right or left position with a 15° head angle.	Other: The bed levels of the patients in the experimental group changed the patient's position; The bed levels of the patients in the experimental group changed the patient's position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Score on Visual Analog Scale (VAS)	Pain will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (severe pain). Higher scores indicate more severe pain.	0 hour (baseline), 1st hour, 2nd hour, 3rd hour
Average Score on Immobilization Comfort Scale (ICS)	Comfort during immobilization will be measured using the Immobilization Comfort Scale (ICS), a 20-item Likert-type scale ranging from 1 (strongly disagree) to 6 (strongly agree). Higher scores indicate greater comfort. Cronbach's alpha in this study ranged from 0.77 to 0.84.	0 hour (baseline), 1st hour, 2nd hour, 3rd hour
Vascular Complication Score	Vascular complications will be assessed using the Oozing and Bleeding Scale and the Ecchymosis and Hematoma Formation Scale developed by Elsaman (2022). Categories include: no bleeding/ecchymosis/hematoma, oozing/bleeding <2 cm², bleeding ≥2 cm², ecchymosis <2 cm², hematoma ≥2 cm². Higher scores indicate more severe vascular complications.	0 hour (baseline), 1st hour, 2nd hour, 3rd hour

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Study Director: Burcu NAL, PhD, Kütahya Health Sciences University, Faculty of Health Sciences; Study Director: Mehmet Ali ASTARCIOĞLU, Prof., Kütahya Health Sciences University, Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Peripheral Vascular Diseases
• Other Study ID Numbers: KutahyaHSU-NECİBE-DAĞCAN-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No