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NCT Number: NCT06853847

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

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.

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Key information

Conditions

Angiopathy, Peripheral Cardiovascular Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necibe

Kütahya, 43000, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The bed levels of the patients in the experimental group changed the patient's position

Other

The bed levels of the patients in the experimental group changed the patient's position

Primary outcomes

  1. Average Pain Score on Visual Analog Scale (VAS)

    Time frame: 0 hour (baseline), 1st hour, 2nd hour, 3rd hour

    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.

  2. Average Score on Immobilization Comfort Scale (ICS)

    Time frame: 0 hour (baseline), 1st hour, 2nd hour, 3rd hour

    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.

  3. Vascular Complication Score

    Time frame: 0 hour (baseline), 1st hour, 2nd hour, 3rd hour

    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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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