Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion
- Conditions
- CryotherapyPercutaneous Coronary InterventionVirtual RealityPain ManagementNursing Caries
- Interventions
- Other: Virtual Reality GlassesOther: Ice Application GroupOther: Control Group
- Registration Number
- NCT06445387
- Lead Sponsor
- Amasya University
- Brief Summary
It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.
- Detailed Description
After obtaining the necessary permissions for the research, the patients who were followed up in the hemodialysis unit of X,Y, Z Hospitals were randomly divided into three groups (virtual reality glasses application, ice application and control group).
Randomization: Since the number of male and female patients was wanted to be kept equal, simple randomization would not be possible, so the stratified randomization method was used.
Patients were assigned to groups in equal numbers according to their femoral sheath sizes. In our clinic, size 6 and 7 femoral sheaths are applied to male patients, and number 6 femoral sheaths are applied to female patients. Male patients were assigned to equal groups according to femoral sheath size 6 and 7.
Since PCI is not performed in our clinic on weekends except for emergencies, data were collected during working hours during a five-day weekday period.
The pain level of the patients was evaluated using a numerical rating scale;
* before the femoral sheath extraction (PAS1),
* during the femoral sheathing (SDQ2),
* immediately after the femoral sheathing (SDQ3),
* 30 minutes after the femoral sheathing (SDQ4) and
* 1 hour after the femoral sheathing (SDQ4). SDÖ5) was evaluated and recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- Intervention in the femoral region,
- Femoral sheath size is 6-7 fr,
- Presence of only one sheath in the femoral region,
- No analgesics were administered before femoral sheath removal,
- Absence of serious bleeding and major hematoma in the femoral region,
- Being over 18 years of age,
- No communication problems,
- Having a place and time orientation,
- No dizziness,
- Not having any psychiatric disease,
- No visual, auditory or mental problems,
- No previously identified cold allergy,
- Being willing and willing to participate in the study,
- Serious bleeding and major hematoma development in the femoral region,
- Not applying intracoronary stent or coronary angioplasty after coronary angiography,
- Vital signs are abnormal enough to prevent intervention,
- Having visual, auditory and mental disabilities,
- Having a communication problem,
- Not being willing and able to participate in the study,
- It is defined as wanting to withdraw from the study at any stage of the study or being excluded from the study by the researcher.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality Glasses Gruop Virtual Reality Glasses The procedure was tested for five minutes, one hour before application, to evaluate the patients' compliance and to detect any possible problems after wearing the glasses. In patients who did not experience any problems after the test, glasses were put on the patient just before the femoral sheath and remained on for 20 minutes. Ice Application Group Ice Application Group Before taking the femoral sheath, the researcher applied cold to the area where the femoral sheath was located with an ice pack for 20 minutes. A femoral sheath was performed immediately after the ice bag was removed. Control Group Control Group The general procedure of the clinic was applied to the control group. Femoral sheath was removed without any invasive procedure.
- Primary Outcome Measures
Name Time Method Pain Scores: Numerical rating scale "through study completion, an average of 1 year". The Numeric Rating Scale is a pain screening tool, commonly used to assess pain severity at that moment in time using a min:0-max:10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable" (10). This scale is a valid and reliable scale developed to determine the pain level of patients. The numerical rating scale simplifies the description of the pain level by the patient and makes it easier for the monitoring nurse to record the patient's pain rating. That the pain increases as the score increases, and then the patient verbally tells the numerical value of the pain intensity he/she feels. Pain score was measured before femoral sheath removal (time 1), and, during femoral sheath removal (2nd time),and, immediately after femoral sheath removal (3rd time), and 30 minutes after femoral sheath removal (4th time), and1 hour after femoral sheath removal (5th time).
- Secondary Outcome Measures
Name Time Method Physiological parameter "through study completion, an average of 1 year". Vital parameters (body temperature measured in degrees Centigrant) of the patients were evaluated
Body temperature was measured before femoral sheath removal (time 1) Body temperature was measured during femoral sheath removal (2nd time) Body temperature was measured immediately after femoral sheath removal (3rd time) Body temperature was measured 30 minutes after femoral sheath removal (4th time) Body temperature was measured 1 hour after femoral sheath removal (5th time)
Trial Locations
- Locations (1)
Amasya University İnstitute of Health Sciences
🇹🇷Amasya, Merkez, Turkey