Recovery With Virtual Reality for Stress and Pain

NCT07679022 | Not Yet Recruiting

• 1 other identifier: 2026-03077-01
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial will evaluate whether a brief preoperative virtual reality intervention reduces anxiety and improves early recovery in adults undergoing elective gynecological surgery. Approximately 140 participants will be randomly assigned in a 1:1 ratio to either virtual reality in addition to usual care or usual care alone. The virtual reality intervention will consist of approximately 10-20 minutes of an immersive relaxation experience before surgery. The primary outcome is the change in preoperative anxiety measured before and after the intervention. Secondary outcomes include postoperative quality of recovery, pain, opioid consumption, postoperative nausea and vomiting, and early recovery-related healthcare outcomes.

Conditions

Preoperative Anxiety; Postoperative Pain; Postoperative Recovery

Keywords

Virtual Reality; Perioperative Care; Gynecologic Surgery; Quality of Recovery; QoR-15; Preoperative Anxiety; Postoperative Pain; Opioid Consumption; Postoperative Nausea and Vomiting; Nonpharmacologic Intervention

Outcome Measures

Primary Outcomes (1)

• Quality of Postoperative Recovery Measured With QoR-15

  Postoperative recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.

  24 hours after surgery

Secondary Outcomes (8)

• Change in Preoperative Anxiety

  From immediately before to immediately after the intervention, approximately 10-20 minutes

• Postoperative Pain Intensity

  Up to 72 hours after surgery

• Postoperative Opioid Consumption

  During the first 24 hours after surgery

• Incidence of Postoperative Nausea and Vomiting

  During the first 24 hours after surgery

• Duration of Stay in the Post-Anesthesia Care Unit

  On the day of surgery

Study Arms (2)

Virtual Reality Plus Usual Care

EXPERIMENTAL

Participants receive a preoperative virtual reality session in addition to usual perioperative care. The session lasts approximately 10-20 minutes and is delivered in the waiting or preoperative area using calm nature or relaxation scenes intended to promote comfort and distraction.

Behavioral: Preoperative Virtual Reality

Usual Care

ACTIVE COMPARATOR

Participants receive usual perioperative care without virtual reality during the corresponding preoperative period.

Other: Usual Perioperative Care

Interventions

Preoperative Virtual Reality BEHAVIORAL

A single preoperative virtual reality session lasting approximately 10-20 minutes, administered in the waiting or preoperative area. Participants view calm nature, relaxation, or guided-breathing scenes using a virtual reality headset. The intervention is intended to provide relaxation, comfort, and distraction before surgery.

Virtual Reality Plus Usual Care

Usual Perioperative Care OTHER

Participants receive standard perioperative care according to local clinical routines. No preoperative virtual reality session is provided during the corresponding intervention period.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Scheduled to undergo elective gynecological surgery according to the study protocol at a participating center where virtual reality can be provided.
• Able and willing to provide informed consent for study participation, 1:1 randomization, and use of virtual reality.

You may not qualify if:

• Increased risk of adverse effects related to virtual reality, including pronounced motion sickness, claustrophobia, or photosensitive epilepsy.
• Active substance use disorder or active misuse of alcohol or illicit drugs.
• Severe chronic pain and/or regular preoperative opioid treatment, as defined in the study protocol.

Sponsors & Collaborators

• Region Skane: lead

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Central Study Contacts

Pether Jildenstål, Professor

CONTACT

+46 76-026 66 58; pether.jildenstal@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study because participants and clinical staff are aware of whether the preoperative virtual reality intervention is administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel-group randomized controlled trial with participants allocated in a 1:1 ratio to preoperative virtual reality plus usual care or usual care alone.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share