Effect of Virtual Reality During Femoral Sheath Removal
The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.
Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.
This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.
The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Hatay
-
İskenderun, Hatay, Turkiet (Türkiye)
- İskenderun Devlet Hastanesi
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Patients aged 18 years and older
- Patients undergoing percutaneous coronary intervention via femoral access
- Patients with only one femoral sheath catheter
- Patients who did not receive analgesic medication before sheath removal
- Patients without severe hemorrhage or major hematoma at the femoral sheath site
- Patients able to communicate in Turkish
- Patients without visual, hearing, or speech impairment
- Patients without mental impairment affecting communication
- Patients without psychiatric diagnosis and not using psychiatric medication
Exclusion Criteria:
Patients unwilling to participate or wishing to withdraw from the study at any stage
- Patients who removed the virtual reality glasses during the intervention
- Patients who experienced intolerance to virtual reality application (e.g., dizziness or nausea)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Virtual Reality Group
Participants received virtual reality glasses during femoral sheath removal
|
Virtual reality glasses were used during femoral sheath removal.
|
|
Övrig: Control Group
Participants received routine care during femoral sheath removal
|
Participants received routine care during femoral sheath removal
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Heart Rate
Tidsram: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
Heart rate was measured in beats per minute using routine monitoring.
|
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
|
Blood Pressure
Tidsram: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
|
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
|
Oxygen Saturation
Tidsram: Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
Oxygen saturation was measured as percent saturation using pulse oximetry.
|
Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
|
Body Temperature
Tidsram: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
|
Body temperature was assessed using routine vital sign monitoring.
|
5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
|
|
Pain Level
Tidsram: 5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
|
Pain level was assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain.
Higher scores indicate greater pain severity.
|
5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
|
|
Anxiety Level
Tidsram: Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
|
Anxiety level was assessed using the State Anxiety Inventory (STAI).
Higher scores indicate higher anxiety levels.
|
Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HKU-2025/069
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .