Angiopathy, PeripheralNCT06853847
Effect of Position Change on Pain, Comfort and Vascular Complications After Coronary Angiography
A study testing The bed levels of the patients in the experimental group changed the patient's position in people with Angiopathy, Peripheral and Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angiopathy, Peripheral, Pain
- What is being tested?
- The bed levels of the patients in the experimental group changed the patient's position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Angiopathy, Peripheral, Pain
- Being tested
- The bed levels of the patients in the experimental group changed the patient's position
- Medical subject headings
- Peripheral Vascular Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The bed levels of the patients in the experimental group changed the patient's positionOther
The bed levels of the patients in the experimental group changed the patient's position
| Study group | Role | What they receive |
|---|---|---|
| back position group | Experimental | 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. Receives: Other: The bed levels of the patients in the experimental group changed the patient's position |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0 hour (baseline), 1st hour, 2nd hour, 3rd hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start25 Mar 2025
- Primary completion15 Apr 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angiopathy, PeripheralStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necibe Dağcan, Kutahya Health Sciences University
- Investigators
- Burcu NAL, PhD, Study director, Kütahya Health Sciences University, Faculty of Health SciencesMehmet Ali ASTARCIOĞLU, Prof., Study director, Kütahya Health Sciences University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853847
- Sponsor's protocol ID
- KutahyaHSU-NECİBE-DAĞCAN-0005
- Status last verified
- Aug 2025
- First submitted
- 25 Feb 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Position Change on Pain, Comfort and Vascular Complications After Coronary Angiography: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06853847
- Acronym / sponsor ID
- KutahyaHSU-NECİBE-DAĞCAN-0005
- Conditions
- Angiopathy, Peripheral, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| back position group | Experimental | Other: The bed levels of the patients in the experimental group changed the patient's positionThe 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. |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 years of age
Key exclusion criteria (17 listed)
- • Not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The bed levels of the patients in the experimental group changed the patient's positionThe bed levels of the patients in the experimental group changed the patient's position | Other | back position group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 41077907Dagcan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The bed levels of the patients in the experimental group changed the patient's position in people with Angiopathy, Peripheral and Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Score on Visual Analog Scale (VAS) (time frame: 0 hour (baseline), 1st hour, 2nd hour, 3rd hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06853847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.