Clinical trial NCT06853847: Effect of Position Change on Pain, Comfort and Vascular Complications After Coronary Angiography
Official title: Effect of Position Change on Pain, Comfort and Vascular Complications After Coronary Angiography: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Angiopathy, Peripheral
Pain
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a double-blind randomized controlled trial planned to investigate the effect of position change after coronary angiography on pain, comfort and vascular complications.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: average pain score
timeFrame: 0 hour, 1st hour, 2nd hour, 3th hour
measure: immobilization comfort scale average
timeFrame: 0 hour, 1st hour, 2nd hour, 3th hour
measure: Vascular Complication average
timeFrame: 0 hour, 1st hour, 2nd hour, 3th hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: