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Clinical Trials/NCT06649383
NCT06649383
Recruiting
Phase 4

Virtual Reality for Elderly Patients in Anesthesia and Surgical Care

Pether Jildenstal2 sites in 1 country90 target enrollmentDecember 16, 2024

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
Pether Jildenstal
Enrollment
90
Locations
2
Primary Endpoint
propofol mg/kg
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

We want to investigate whether Virtual Reality (VR) could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia.

Detailed Description

This study is a randomized controlled trial based on both quantitative and qualitative methods. Inclusion criteria are elderly patients aged ≥65 years with an estimated surgery time of a maximum of 90 minutes, who undergo surgery/treatment under local anesthesia and sedation. Randomization is to either standard sedation or sedation/VR. Randomization is carried out using mixed, sealed envelopes. The studies will be conducted at the following locations: Hallands Hospital, Kungsbacka: Open inguinal hernia surgery with implant, anesthesia type is infiltration anesthesia. Sahlgrenska Hospital: Intervention, cannulation of the groin and vascular surgery performed via catheters/guides on blood vessels, liver, pancreas, and abdominal organs, with anesthesia type infiltration. Alingsås Hospital: Surgery on the hand, arm, lower extremity, urology, with anesthesia type block and infiltration. Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory (STAI-S) and pain assessment using a numerical rating scale (NRS) from 0-11. We also plan to use an objective marker for measuring anxiety-induced stress perioperatively, such as heart rate variability or skin conductance measurement. Postoperative data will include STAI-S, NRS, intraoperative sedative medication (type and dosage in mg/kg), time to urination, time to oral nutrition, discharge time, and time spent in the postoperative ward. The patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively. The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery. The primary outcome effect of VR glasses on mg/kg of propofol used intraoperatively or another sedative drug and/or the amount of local anesthetic used in mg. The secondary outcome effect of VR glasses on anxiety-induced stress perioperatively, where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory (STAI-S).

Registry
clinicaltrials.gov
Start Date
December 16, 2024
End Date
June 15, 2029
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pether Jildenstal
Responsible Party
Sponsor Investigator
Principal Investigator

Pether Jildenstal

Professor Pether Jildenstal Gothenburg University

Göteborg University

Eligibility Criteria

Inclusion Criteria

  • over 65 years, planed surgery in local anesthesia/regional anesthesia

Exclusion Criteria

  • dementia, unable to cooperate, cognitive impairment

Outcomes

Primary Outcomes

propofol mg/kg

Time Frame: during the surgery (90 minutes max)

dose of propofol given during surgery to the participant

Secondary Outcomes

  • Surgeons satisfaction(Directly after surgery is finished)
  • Stress/anxiety(during the surgery (90 minutes max))
  • Nurse anesthetists experience, (questionnaire).(Directly after surgery is finished)
  • Level of pain(Directly after surgery is finished)

Study Sites (2)

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