NCT06088095

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

October 5, 2023

Last Update Submit

February 27, 2025

Conditions

Coronary Disease

Keywords

comfortcoronary angiographyvital signs

Outcome Measures

Primary Outcomes (4)

  • Pulse rate per minute

    Vital signs

    20 minutes

  • blood pressure rate, mmHg

    Vital signs

    20 minutes

  • respiratory rate per minute

    Vital signs

    20 minutes

  • SpO2 value of the patients will be measured.

    Vital signs

    20 minutes

Secondary Outcomes (1)

  • General Comfort Scale

    The comfort scale will be filled 2 hours after mobilization.

Study Arms (2)

intervention group

EXPERIMENTAL
Other: Mobility group

control group

NO INTERVENTION

Interventions

Mobility groupOTHER

Patients will be mobilized in accordance with the gradual mobilization procedure 12 hours after the angiography procedure.

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Those with hypertension
  • Individuals with psychological and neurological disorders
  • Patients with communication problems
  • Patients with deterioration in hemodynamics after angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Hospital

Kayseri, 38039, Turkey (Türkiye)

Location

Related 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.

    PMID: 36414367BACKGROUND

  • 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.

    PMID: 27931870BACKGROUND

  • 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.

    PMID: 32020631BACKGROUND

  • 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.

    PMID: 19296949BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 18, 2023

Study Start

March 15, 2024

Primary Completion

May 1, 2024

Study Completion

August 30, 2024

Last Updated

March 3, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)