Percutaneous Coronary InterventionNCT03131271
Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention
A study testing cold application in people with Percutaneous Coronary Intervention, run by TC Erciyes University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The exclusion criteria were; refusal to participate, groin lesion at the time of sheath removal, unstable vital signs, the use of radial acces
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- cold application
- Keywords
- Percutaneous coronary intervention, Femoral arterial catheter, Pain, Cold application, Nursing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startSep 2013
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut Bayındır, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131271
- Sponsor's protocol ID
- TYL-2013-4765
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03131271
- Acronym / sponsor ID
- TYL-2013-4765
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Percutaneous coronary intervention, Femoral arterial catheter, Pain, Cold application, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: cold applicationIn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The exclusion criteria were; refusal to participate, groin lesion at the time of sheath removal, unstable vital signs, the use of radial acces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold applicationIn the experimental group, the researcher provided a cold application for 20 minutes by placing an ice bag to the site of the femoral catheter. | Other | Experimental Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cold application in people with Percutaneous Coronary Intervention, run by TC Erciyes University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.