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NCT Number: NCT06649383

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

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.

Recruiting

Interested in participating?

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alingsås lasarett, Alingsås, Västra Götaland County, Sweden

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • dementia, unable to cooperate, cognitive impairment

Treatment and study plan

Virtual reality

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.

Primary outcomes

  1. propofol mg/kg

    Time frame: during the surgery (90 minutes max)

    dose of propofol given during surgery to the participant

Secondary outcomes

  1. Surgeons satisfaction

    Time frame: Directly after surgery is finished

    surgeons satisfaction, measured with NASA task load index (tlx). Higher score, worse outcome.

  2. Stress/anxiety

    Time frame: during the surgery (90 minutes max)

    Stress or anxiety felt during surgery by participant, measured with State-Trait Anxiety Inventory (STAI) . Higher score worse outcome.

  3. Nurse anesthetists experience, (questionnaire).

    Time frame: Directly after surgery is finished

    Nurse anesthetists experience will be measured with a questionnaire egarding how well the monitoring of the patient could be carried out and the degree to which the patient was perceived as calm. The higher score, the better.

  4. Level of pain

    Time frame: Directly after surgery is finished

    Patients level of pain after surgery, measured with Numeric rating scale (NRS). The higher scores mean worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Pether Jildenstål, Docent

CONTACT

[email protected]

+46760266658

Sponsors and collaborators

Lead sponsor

Pether Jildenstal

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

Virtual Reality for Elderly Patients in Anesthesia and Surgical Care

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Oct 18, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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