Comfort Level After Transfemoral Coronary Angiography

Coronary Disease Clinical Trial

Official title:

The Effect of Gradual Mobilization on Vital Signs and Comfort Level After Transfemoral Coronary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088095
• Other study ID #: coronary angiography
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 29, 2024

Study information

• Verified date: February 2024
• Source: TC Erciyes University
• Contact: ÖZLEM CEYHAN
• Phone: +90352 207 6666
• Email: ozlemg[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 29, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals who can be contacted at a level that can answer research questions

• Individuals with transfemoral angiography

Exclusion Criteria:

• Those with hypertension

• Individuals with psychological and neurological disorders

• Patients with communication problems

• Patients with deterioration in hemodynamics after angiography

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Other:
• Mobility group
Patients will be mobilized in accordance with the gradual mobilization procedure 12 hours after the angiography procedure.

Locations

Country	Name	City	State
Turkey	Erciyes University Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Ibdah 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. — View Citation

Ramos 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. — View Citation

Rezaei-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse rate per minute	Vital signs	20 minutes
Primary	blood pressure rate, mmHg	Vital signs	20 minutes
Primary	respiratory rate per minute	Vital signs	20 minutes
Primary	SpO2 value of the patients will be measured.	Vital signs	20 minutes
Secondary	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).	The comfort scale will be filled 2 hours after mobilization.