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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03131271
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Sevda Korkut Bayındır, TC Erciyes University

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.

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Other: cold application Not Applicable

Detailed Description:

Although several arterial access routes may be employed during percutaneous coronary intervention (PCI), the femoral arterial site has been the most commonly used (1). However, during femoral artery interventions, many patients experience pain and discomfort during the removal of catheters previously inserted into the femoral region (2,3). Previous literature also provides evidence that both vasovagal responses and local vascular complications may develop when the pain induced by catheter removal is not effectively controlled (3-5); therefore, it is important to reduce the pain experienced by patients undergoing this procedure (6).

Pain caused by the removal of a femoral catheter may be controlled by using pharmacological methods such as treatment with morphine sulfate or lidocaine infiltration (2,3). However, it is also been observed that such approaches may cause complications such as increased bleeding, laceration of catheters, infection and temporary nerve injury (7-9). Pain may be also be controlled using non-pharmacological methods, which are patient-specific and aim to establish empathic communication with healthcare staff (10-13). Non-pharmacological methods used for pain control provided positive effects such as reduced anxiety and psychological support; notably, patients have expressed satisfaction with such non-pharmacological methods (14).

Cold application is a non-pharmacological method of pain control (6). Being one of the oldest and easiest forms of treatment, cold-application increases the threshold of pain and reduces the conduction velocity of nerve fibres transmitting pain stimuli from the peripheral to the central nervous system (15). Demir et al. (10) investigated the effect of cold application upon pain caused by the removal of a chest tube and revealed that cold application reduced pain intensity and delayed patient requests for a second analgesic. In a further study by Ertug et al. (11), cold application was highly effective in reducing the pain caused by chest tube removal. Cold application also confers other advantages, such as ease of application, the lack of serious side effects and low cost (16).

Aim and Hypothesis of the Study This study aimed to determine the effect of cold application to the femoral region upon pain levels of patients receiving PCI. Our hypothesis was that cold application would reduce (1) the pain score associated with removal of a femoral catheter after PCI, (2) the behavioural responses of discomfort associated with removal of a femoral catheter after PCI and (3) the incidence of adverse reactions associated with removal of a femoral catheter after PCI.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention
Actual Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Experimental Group
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
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.

No Intervention: Control Group
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.

Primary Outcome Measures :
  1. Change in pain intensity [ Time Frame: 9 months ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Inclusion criteria were: able to speak and understand Turkish, over 18 years of age, about to undergo a femoral intervention to insert a single catheter in their femoral region, unimpaired time and place orientation with no psychiatric disorders or no visual or hearing problem, no cold allergy, normal vital signs and avoidance of analgesic treatment prior to catheter removal.

Exclusion Criteria:

  • The exclusion criteria were; refusal to participate, groin lesion at the time of sheath removal, unstable vital signs, the use of radial acces

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Responsible Party: Sevda Korkut Bayındır, Principal Investigator, TC Erciyes University Identifier: NCT03131271     History of Changes
Other Study ID Numbers: TYL-2013-4765
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sevda Korkut Bayındır, TC Erciyes University:
Percutaneous coronary intervention
Femoral arterial catheter
Cold application