Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

Amasya University

Status: Completed

Conditions: Percutaneous Coronary Intervention; Cryotherapy; Pain Management; Virtual Reality; Nursing Caries

Treatments: Other: Ice Application Group; Other: Control Group; Other: Virtual Reality Glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT06445387

AU-SBE-ASoylu-03

Details and patient eligibility

About

It is to examine the effect of virtual reality and ice application on the pain level due to femoral sheath extraction.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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,

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

Virtual Reality Glasses Gruop

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality Glasses

Ice Application Group

Experimental group

Description:

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.

Treatment:

Other: Ice Application Group

Control Group

Other group

Description:

The general procedure of the clinic was applied to the control group. Femoral sheath was removed without any invasive procedure.

Treatment:

Other: Control Group