Clinical trial NCT03131271: Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention
Official title: Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Keywords: Percutaneous coronary intervention
Femoral arterial catheter
Pain
Cold application
Nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain intensity
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
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