Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication

NCT ID: NCT06649383

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2029-06-15

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).

Conditions

Virtual Reality; Distraction; Elderly (people Aged 65 or More)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR group

This group use VR glasses during surgery

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: DEVICE

Participant will try virtual reality glasses with tailormade software films to see if it's possible to use them as distraction during awake surgery. We will measure doses of propofol given, level of anxiety, experience of the patient and surgeons satisfaction.

Control group

Control group without intervention, conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality

Participant will try virtual reality glasses with tailormade software films to see if it's possible to use them as distraction during awake surgery. We will measure doses of propofol given, level of anxiety, experience of the patient and surgeons satisfaction.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• dementia, unable to cooperate, cognitive impairment

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Pether Jildenstal

OTHER

Sponsor Role: lead

Responsible Party

Pether Jildenstal

Professor Pether Jildenstal Gothenburg University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Alingsås lasarett

Alingsås, Västra Götaland County, Sweden

Site Status: RECRUITING

Sahlgrenska universitetssjukhuset

Gothenburg, Västra Götaland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Pether Jildenstål, Docent

Role: CONTACT

pether.jildenstal@vgregion.se

+46760266658

Facility Contacts

Joakim Strömberg, associate professor

Role: primary

joakim.stromberg@vgregion.se

0046313421000

Kristian Hermander, Nurse anesthetist

Role: primary

kristian.hermander@vgregion.se

+46709374816

Kristian Hermander

Role: backup

Other Identifiers

2023-04059-01

Identifier Type: -

Identifier Source: org_study_id