Coronary DiseaseNCT06088095
Comfort Level After Transfemoral Coronary Angiography
A study testing Mobility group in people with Coronary Disease, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
With the increase in the number of cardiovascular diseases, the safety of the angiography method used in diagnosis and treatment becomes important. The transfemoral approach is often preferred during angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Mobility group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 30 Aug 2024
- 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
- Individuals who can be contacted at a level that can answer research questions
- Individuals with transfemoral angiography
Who cannot join
- Those with hypertension
- Individuals with psychological and neurological disorders
- Patients with communication problems
- Patients with deterioration in hemodynamics after angiography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gradual Mobilization on Vital Signs and Comfort Level After Transfemoral Coronary Angiography
With the increase in the number of cardiovascular diseases, the safety of the angiography method used in diagnosis and treatment becomes important. The transfemoral approach is often preferred during angiography. It is recommended to have bed rest for 6-12 hours after transfemoral angiography (TFA) to prevent possible complications. In order to reduce the complications arising from angiography, it is predicted from the studies that giving the patient a therapeutic position, elevating the head of the bed and gradual early mobilization will reduce the patients' groin pain, prevent urinary retention and increase patient comfort. In this study, the effect of gradual mobilization after transfemoral angiography on the vital signs, complications and comfort level of the patients. It is planned to be done to determine the
- Conditions
- Coronary Disease
- Being tested
- Mobility group
- Keywords
- comfort, coronary angiography, vital signs
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility groupOther
Patients will be mobilized in accordance with the gradual mobilization procedure 12 hours after the angiography procedure.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: Mobility group |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse rate per minute
Vital signs
Measured: 20 minutes
blood pressure rate, mmHg
Vital signs
Measured: 20 minutes
respiratory rate per minute
Vital signs
Measured: 20 minutes
SpO2 value of the patients will be measured.
Vital signs
Measured: 20 minutes
Secondary outcomes (1)
General Comfort Scale
It is used to determine the comfort level of patients. The highest score that can be given to the positive items in the scale, four (4), indicates high comfort, and the lowest score, one (1), indicates low comfort. Thus, the lowest score that can be obtained in the GAS is 48 points, while the highest score is 192 points. As the score obtained from the scale increases, the comfort level perceived by the patient increases. The total score obtained is divided by 48, which is the number of scale items, and the average value is found in the range of 1-4. If the patient performing the scale has low comfort, it is expressed as one (1), and if the patient has high comfort, it is expressed as four (4).
Measured: The comfort scale will be filled 2 hours after mobilization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Mar 2024
- Primary completion1 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ceyhan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088095
- Sponsor's protocol ID
- coronary angiography
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsaman SEA. Association of position change and back massage and early ambulation with post-transfemoral coronary angiography complications. J Vasc Nurs. 2022 Sep;40(3):128-133. doi: 10.1016/j.jvn.2022.08.003. Epub 2022 Sep 11.
PubMed 36414367Ramos Dos Santos PM, Aquaroni Ricci N, Aparecida Bordignon Suster E, de Moraes Paisani D, Dias Chiavegato L. Effects of early mobilisation in patients after cardiac surgery: a systematic review. Physiotherapy. 2017 Mar;103(1):1-12. doi: 10.1016/j.physio.2016.08.003. Epub 2016 Sep 14.
PubMed 27931870Ibdah RK, Ta'an WF, Shatnawi RM, Suliman MM, Rababah JA, Rawashdeh SI. The effectiveness of early position change postcardiac catheterization on patient's outcomes: A randomized controlled trial. Nurs Forum. 2020 Jul;55(3):380-388. doi: 10.1111/nuf.12438. Epub 2020 Feb 5.
PubMed 32020631Rezaei-Adaryani M, Ahmadi F, Asghari-Jafarabadi M. The effect of changing position and early ambulation after cardiac catheterization on patients' outcomes: a single-blind randomized controlled trial. Int J Nurs Stud. 2009 Aug;46(8):1047-53. doi: 10.1016/j.ijnurstu.2009.02.004. Epub 2009 Mar 17.
PubMed 19296949
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gradual Mobilization on Vital Signs and Comfort Level After Transfemoral Coronary Angiography
- ClinicalTrials.gov ID
- NCT06088095
- Acronym / sponsor ID
- coronary angiography
- Conditions
- Coronary Disease
- Keywords
- comfort, coronary angiography, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 18 Oct 2023 (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.
With the increase in the number of cardiovascular diseases, the safety of the angiography method used in diagnosis and treatment becomes important. The transfemoral approach is often preferred during angiography. It is recommended to have bed rest for 6-12 hours after transfemoral angiography (TFA) to prevent possible complications. In order to reduce the complications arising from angiography, it is predicted from the studies that giving the patient a therapeutic position, elevating the head of the bed and gradual early mobilization will reduce the patients' groin pain, prevent urinary retention and increase patient comfort. In this study, the effect of gradual mobilization after transfemoral angiography on the vital signs, complications and comfort level of the patients. It is planned to be done to determine the
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Mobility group |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who can be contacted at a level that can answer research questions
- Individuals with transfemoral angiography
Key exclusion criteria (4 listed)
- Those with hypertension
- Individuals with psychological and neurological disorders
- Patients with communication problems
- Patients with deterioration in hemodynamics after angiography
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 |
|---|---|---|
| Mobility groupPatients will be mobilized in accordance with the gradual mobilization procedure 12 hours after the angiography procedure. | Other | intervention group |
Primary outcome
Pulse rate per minute
Time frame: 20 minutes
Vital signs
blood pressure rate, mmHg
Time frame: 20 minutes
Vital signs
respiratory rate per minute
Time frame: 20 minutes
Vital signs
SpO2 value of the patients will be measured.
Time frame: 20 minutes
Vital signs
1 secondary outcome
General Comfort Scale
Time frame: The comfort scale will be filled 2 hours after mobilization.
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 3 Mar 2025.
- Background: PubMed 36414367Elsaman SEA. Association of position change and back massage and early ambulation with post-transfemoral coronary angiography complications. J Vasc Nurs. 2022 Sep;40(3):128-133. doi: 10.1016/j.jvn.2022.08.003. Epub 2022 Sep 11.
- Background: PubMed 27931870Ramos Dos Santos PM, Aquaroni Ricci N, Aparecida Bordignon Suster E, de Moraes Paisani D, Dias Chiavegato L. Effects of early mobilisation in patients after cardiac surgery: a systematic review. Physiotherapy. 2017 Mar;103(1):1-12. doi: 10.1016/j.physio.2016.08.003. Epub 2016 Sep 14.
- Background: PubMed 32020631Ibdah RK, Ta'an WF, Shatnawi RM, Suliman MM, Rababah JA, Rawashdeh SI. The effectiveness of early position change postcardiac catheterization on patient's outcomes: A randomized controlled trial. Nurs Forum. 2020 Jul;55(3):380-388. doi: 10.1111/nuf.12438. Epub 2020 Feb 5.
- Background: PubMed 19296949Rezaei-Adaryani M, Ahmadi F, Asghari-Jafarabadi M. The effect of changing position and early ambulation after cardiac catheterization on patients' outcomes: a single-blind randomized controlled trial. Int J Nurs Stud. 2009 Aug;46(8):1047-53. doi: 10.1016/j.ijnurstu.2009.02.004. Epub 2009 Mar 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility group in people with Coronary Disease, run by TC Erciyes 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 2 inclusion and 4 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 3 Mar 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?
Pulse rate per minute (time frame: 20 minutes). The study lists 4 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 NCT06088095, which also lists 4 linked publications.
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 3 Mar 2025.