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CompletedNCT06853847Updated Aug 29, 2025

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

An interventional study of The bed levels of the patients in the experimental group changed the patient's position in Angiopathy, Peripheral and Pain, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Angiopathy, Peripheral
  • Pain
03

In context

Peripheral Vascular Diseases

1,020 studies on the registry are indexed under Peripheral Vascular Diseases; 124 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 722 interventional studies indexed under Peripheral Vascular Diseases.

Browse Peripheral Vascular Diseases studies →

Lead sponsor

Kutahya Health Sciences University is the lead sponsor of 209 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

    No intervention

Interventions

  • OtherThe 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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

07

Study locations

1 site
  • Necibe
    Kütahya, 43000, Turkey (Türkiye)
08

References and documents

Publications

  • Dagcan Sahin N, Nal B, Astarcioglu MA. Effect of Position Change After Coronary Angiography on Pain, Vital Signs, Comfort, and Vascular Complications: A Randomized Controlled Trial. Catheter Cardiovasc Interv. 2025 Dec;106(7):3695-3704. doi: 10.1002/ccd.70259. Epub 2025 Oct 12. PubMed 41077907 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06853847
Lead sponsor
Kutahya Health Sciences University
Responsible party
Necibe Dağcan (Assistant Professor of Nursing, Kutahya Health Sciences University) — Principal investigator
First posted
Mar 3, 2025
Start date
Mar 25, 2025
Primary completion
Apr 15, 2025
Completion
Aug 25, 2025
Last update
Aug 29, 2025

Study contacts

Burcu NAL, PhD
study director · Kütahya Health Sciences University, Faculty of Health Sciences
Mehmet Ali ASTARCIOĞLU, Prof.
study director · Kütahya Health Sciences University, Faculty of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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