Use of Back Support After Transfemoral Angiography

NCT06643182 | Not Yet Recruiting

• 1 other identifier: 2024/5744
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.

Conditions

Patient Engagement; Femoral Angiography

Keywords

femoral angiography; back support; vital signs; comfort

Outcome Measures

Primary Outcomes (5)

• Effect of back support use on pulse

  Patients will be monitored for 6 hours in a supported supine position and Pulse will be recorded at 3-hour intervals.

  6 hour (Data collection time for each patient)

• Effect of back support use on blood pressure

  Patients will be monitored for 6 hours in a supported supine position and blood pressure will be recorded at 3-hour intervals.m

  6 hour (Data collection time for each patient)

• Effect of back support use on respiratory rate

  Patients will be monitored for 6 hours in a supported supine position and respiratory rate will be recorded at 3-hour intervals.m

  6 hour (Data collection time for each patient)

• Effect of back support use on partial oxygen saturation

  Patients will be monitored for 6 hours in a supported supine position and partial oxygen saturation will be recorded at 3-hour intervals.m

  6 hour (Data collection time for each patient)

• Effect of back support use on comfort

  The immobilization comfort scale consists of 20 items and 6 statements. The total score is between 20 and 120. Scoring was done before and after back support.

  6 hour

Secondary Outcomes (1)

• Effect of back support use on pain

  6 hour

Study Arms (2)

Back Gupport Group

EXPERIMENTAL

After the transfemoral angiography procedure, the patient will be taken to bed and monitored. Approximately 2 hours after the procedure, under the control of the doctor and nurse, the sheath in the patient's groin area will be pulled and a 3 kg sandbag will be left. A 36x33x10 cm gel-containing visco pillow will be placed in the patient's lumbar cavity by the research nurse and primary nurse to fill the anatomical space. The patient will be monitored in a supine position with the head elevated (30 degrees) and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours.

Other: Back Support

Control Group

NO INTERVENTION

The patients in this group will be monitored in the supine position with the head elevated (30 degrees) without pillow support and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours.

Interventions

Back Support OTHER

When the sandbag is to be left by the researcher together with the nurse caring for the patient, the patient will be placed in the left lateral position for a short time, a gel-filled orthopedic non-sweating viscose pillow will be placed in the patient's lumbar region and the patient will be placed in a supine position with the head supported.

Back Gupport Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over the age of 18 who underwent femoral coronary angiography,
• Patients who did not have verbal communication problems,
• Patients who consented to participate in the study were determined as patients.

You may not qualify if:

• Patients who underwent radial angiography,
• Have chronic low back pain,
• Have had previous back surgery/herniated disc,
• Have coagulation problems (PLT\<50000 mm3),
• Did not consent to participate in the study,
• Have communication problems.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Tunceli State Hospital

Tunceli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Dilek Olmaz, PhD

CONTACT

+90 5349598752; dilekolmaz62@hotmail.com

Mensure Turan, PhD

CONTACT

+90 536 412 51 21; mensurekyn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate proffesor

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: October 16, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)