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

NCT ID: NCT06853847

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2025-08-25

Brief Summary

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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

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

Conditions

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Angiopathy, Peripheral Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Patients will be divided into experimental and control groups. Patients will know that they are participating in the study and the interventions that will be applied to them, but they will be blinded by not knowing which group they are in. The study data will be collected by a second researcher who is blinded to the groups. In the statistical analysis of the data, the groups will be labeled as group 1 and group 2, and the third researcher will be blinded when evaluating the results. Thus, the third researcher will be blinded to the study groups. In order to avoid bias in the evaluation of the results, the first researcher who is not blinded will not participate in any stage of the evaluation process.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Necibe Dağcan

Assistant Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burcu NAL, PhD

Role: STUDY_DIRECTOR

Kütahya Health Sciences University, Faculty of Health Sciences

Mehmet Ali ASTARCIOĞLU, Prof.

Role: STUDY_DIRECTOR

Kütahya Health Sciences University, Faculty of Health Sciences

Locations

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Necibe

Kütahya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KutahyaHSU-NECİBE-DAĞCAN-0005

Identifier Type: -

Identifier Source: org_study_id

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