NCT07274098

Brief Summary

Virtual reality (VR) headsets (like those used in gaming) allow users to feel immersed in an artificial 3 dimensional environment. The user is able to look around within the environment and interact with it. Virtual reality has been used extensively in video games and also in training eg in flight simulators used to train pilots. There is now a growing use of VR in a clinical setting as virtual reality environments have been designed to help users relax and reduce anxiety or distract and reduce pain. Trials have shown that these can work in many situations including helping relax staff who are working in highly stressful situations, or to distract and help reduce pain in patients following injuries or during minor operations. The relaxation environments use pictures and sounds to create calm environments and can guide users in breathing exercises which help calm and relax. This study is to investigate whether it will be possible to do a study using a VR headset with a relaxation experience, in the days following abdominal surgery that leads to a reduction in anxiety and pain. Two groups of patients will be studied, one group will use the head set twice a day for up to 5 days and the other will not. They will record their pain and anxiety on a scale of 1 to 10 every day. The amount of pain reducing medicines that they need will also be recorded. The patients will be randomly divided into the 2 groups, they will not get to choose. The researchers will see whether patients are happy to use the headsets following surgery and at the end of the study, the pain and anxiety scores for the group which used the VR headset will be compared with the scores for the group that didn't.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 26, 2025

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent of participants in the virtual reality group who complete 80% of potential sessions (i.e. twice per day until discharge; maximum 5 days)

    Percent of participants in the virtual reality group who complete 80% of potential sessions (i.e. twice per day until discharge; maximum 5 days)

    (i.e. twice per day until discharge; maximum 5 days)

Study Arms (2)

Standard of Care

NO INTERVENTION

This arm received Standard care

Virtual Reality

EXPERIMENTAL

This arm receives the VR intervention Virtual Reality

Device: Virtual reality

Interventions

If randomised to VR then the patient will wear the unit twice a day, morning and afternoon, if possible, before the ward drug round, for a maximum of 5 days whilst they are in hospital. The number of days will depend on the length of time the participant is in hospital post surgery.

Virtual Reality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 years and above Having elective laparoscopic colorectal surgery Patients who are able to understand English and can understand the Participant Information Sheet and give informed consent to take part in the study.

You may not qualify if:

  • presence of motion sickness
  • stroke
  • Severe nausea
  • isolation status for infection control
  • neurological conditions i.e. dementia, seizure, epilepsy
  • Suffering from delirium or acute confusional state
  • Skin on face or head is broken i.e. head wounds or dermatological conditions
  • Conversion to open surgery, if decided prior to consent
  • Patients with severe visual impairment (i.e., not able to clearly see without glasses; patients with contact lenses will not be excluded).
  • Use of strong opioids (i.e., morphine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent and Canterbury Hospital

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 10, 2025

Study Start

April 16, 2025

Primary Completion

June 9, 2025

Study Completion

August 8, 2025

Last Updated

December 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations