Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention

NCT03131271 | Completed

• 1 other identifier: TYL-2013-4765
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Removal of femoral arterial catheter causes pain, and current interventions used for reducing this pain are not sufficiently effective. Aims: The aim of this study is to determine the pain reduction effectiveness of ice bag applications to the femoral region in patients undergoing percutaneous coronary intervention. Design: A randomized controlled trial with repeated measures and two-group design. Setting: This study was conducted at the Yilmaz-Mehmet Oztaskın Heart and Vascular Hospital located in Kayseri, Turkey. Participants: The study was completed with a total of 104 patients who met the inclusion criteria: 52 each in the experimental group and the control group. Methods: The data were collected by the researcher using Patient Identification Form, Numerical Rating Scale (NRS), and Vital Signs Monitoring Form. An ice bag was applied to patients in the experimental group for 20 minutes before removal of the catheter. The nurse performing the application was also responsible for the catheter removal, immediately after the ice bag was removed. Standard procedures of the clinic were applied to the control group. According to the relevant standard procedures, the catheter was removed by the nurse without making any other application to femoral region, and pressure was applied on catheter site. The pain experienced by the patients was evaluated before, and during removal and again while the nurse applied pressure on the catheter site after removal. The NRS scores were identified as NRS1, NRS2 and NRS3 for the three assessment, respectively.

Conditions

Percutaneous Coronary Intervention

Keywords

Percutaneous coronary intervention; Femoral arterial catheter; Pain; Cold application; Nursing

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity

  self reported pain intensity immediately prior to catheter removal, during catheter removal, and while the nurse applied pressure on catheter site within the first minute after removal

  9 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

In the experimental group, the researcher provided a cold application for 20 minutes by placing an ice bag to the site of the femoral catheter. Immediately after its removal, the responsible nurse removed the catheter. A neutral instruction set was used on each patient prior to application of the ice pack. Patients in the experimental group were told that they may or may not experience pain during the catheter removal. The patients were also told that the aim of the study was to measure the effect of ice bag application upon pain during catheter removal, and that ice pack application may or may not be effective in terms of their own pain.

Other: cold application

Control Group

NO INTERVENTION

The control group received the standard clinic procedure in that the catheter was removed by the assigned nurse without any cold application to the femoral region. Each control patient was informed that some patients may experience pain during catheter removal, and that they may or may not experience pain. Patients were also told that their pain levels would be measured during catheter removal.

Interventions

cold application OTHER

In the experimental group, the researcher provided a cold application for 20 minutes by placing an ice bag to the site of the femoral catheter.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 27, 2017
• Study Start: September 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share