Trial Outcomes & Findings for Interest of Virtual Reality on Anxiety Before the Planning CT Scan in Radiotherapy (NCT NCT05269186)

Last Updated: 2026-06-18

Results Overview

Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.

Recruitment status

COMPLETED

Study phase

Target enrollment

256 participants

Primary outcome timeframe

10 minute before the planning CT scan

Results posted on

2026-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Virtual Reality Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan	Normal Care Normal care without intervention
Overall Study STARTED	128	128
Overall Study COMPLETED	120	122
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Virtual Reality Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan	Normal Care Normal care without intervention
Overall Study Missing STAI questionner	8	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Virtual Reality n=128 Participants Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan	Normal Care n=128 Participants Normal care without intervention	Total n=256 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 12 • n=128 Participants	66 years STANDARD_DEVIATION 11 • n=128 Participants	65 years STANDARD_DEVIATION 12 • n=256 Participants
Sex: Female, Male Female	71 Participants n=128 Participants	72 Participants n=128 Participants	143 Participants n=256 Participants
Sex: Female, Male Male	57 Participants n=128 Participants	56 Participants n=128 Participants	113 Participants n=256 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Cancer type Pelvis cancer	64 Participants n=128 Participants	64 Participants n=128 Participants	128 Participants n=256 Participants
Cancer type Breast cancer	64 Participants n=128 Participants	64 Participants n=128 Participants	128 Participants n=256 Participants
BMI	26.7 kg/m² STANDARD_DEVIATION 4.4 • n=127 Participants • Missing value in height or weight section, i.e. BMI cannot be calculated	26.2 kg/m² STANDARD_DEVIATION 5.0 • n=125 Participants • Missing value in height or weight section, i.e. BMI cannot be calculated	26.5 kg/m² STANDARD_DEVIATION 4.7 • n=252 Participants • Missing value in height or weight section, i.e. BMI cannot be calculated

PRIMARY outcome

Timeframe: 10 minute before the planning CT scan

Outcome measures

Outcome measures
Measure	Virtual Reality n=120 Participants Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan	Normal Care n=122 Participants Normal care without intervention
Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management	32 score on a scale Interval 30.2 to 33.7	36.2 score on a scale Interval 34.4 to 37.9

Adverse Events

Virtual Reality

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Normal Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Virtual Reality n=120 participants at risk Virtual reality session performed before the planning CT scan Virtual reality software: The patient will undergo a 20-minute virtual reality session before the planning CT scan	Normal Care n=122 participants at risk Normal care without intervention
General disorders Claustrophobia	0.83% 1/120 • Number of events 1 • From the simulation CT scan to the first radiotherapy session (i.e 15 days) No adverse events related to the intervention (virtual reality headset) were reported.	0.82% 1/122 • Number of events 1 • From the simulation CT scan to the first radiotherapy session (i.e 15 days) No adverse events related to the intervention (virtual reality headset) were reported.

Additional Information

ZINZONI Vanessa

Centre Hospitalier Départemental Vendée

Phone: 0251446285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place