Clinical Trials Directory

Trials / Completed

CompletedNCT06445387

Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

The Effect of Virtual Reality Glasses and Ice Applıcatıon on the Level of Pain During Femoral Sheath Removal in Patients Undergoing Percutaneous Coronary Intervenion

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
108 (actual)
Sponsor
Amasya University · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVirtual Reality GlassesPreparation Stage of Virtual Glasses: A 20-minute video consisting of nature scenes shot with a 360-degree camera was selected by the researchers from YouTube. Permission was obtained from the person who created the video. For the selection of music, both the music that is good for diseases were examined in the literature and an expert opinion was taken from a faculty member (Phd, assistant professor) working at the Faculty of Music and Fine Arts of a university. The music used in the video was created with works selected from the Hüseyni maqam.
OTHERIce Application GroupFeatures of the ice and ice bag used for patients in ice application; Ice cubes with dimensions of 9.5 x 26 x 3.5 cm were used. The ice bag is made of cotton and polyester coated fabric and is easily bendable. In this way, the ice bag was ensured to fit properly to the patient's femoral region. It is reusable and heat insulated. The procedure was carried out by following the cold application step protocol created by the researchers using the literature.
OTHERControl GroupThey continued to receive their routine treatment and care. No changes were made in their routine treatment and care.

Timeline

Start date
2021-07-12
Primary completion
2022-11-03
Completion
2023-01-04
First posted
2024-06-06
Last updated
2024-06-06

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06445387. Inclusion in this directory is not an endorsement.