Relaxation and stress reduction through a virtual reality intervention

Facilitating relaxation and stress reduction through a virtual reality intervention: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11162338

Enrollment

100

Registered

2021-03-03

Start date

2020-10-01

Completion date

Unknown

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress and stress-related disorders Mental and Behavioural Disorders

Interventions

Participants will be randomly assigned to either the treatment (virtual reality, VR) or the active control group (freely chosen relaxation method) according to an externally constructed randomization

during the relaxation phase, sunrise is simulated. Via headphones calming music and nature sounds will be presented to the participants. During the relaxation phase, participants will be seated on a c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years

Exclusion criteria

Exclusion criteria: 1. Current psychiatric disorder or cardiovascular disease 2. Current intake of psychoactive or neuroactive drugs

Design outcomes

Primary

Measure	Time frame
1. Stress ratings measured with a visual analogue scale (VAS) on a Likert scale ranging from 0 (not stressed) to 9 (very stressed) at pre-baseline, post-baseline, pre-stress, mid stress, post-stress, pre-relaxation, post-relaxation, pre-recovery, post-recovery and in the evening of the day of laboratory testing 2. Relaxation ratings will be measured with a VAS on a Likert scale ranging from 0 (not relaxed) to 9 (very relaxed) at pre-baseline, post-baseline, pre-stress, mid stress, post-stress, pre-relaxation, post-relaxation, pre-recovery, post-recovery and in the evening of the day of laboratory testing	—

Measure

Time frame

1. Stress ratings measured with a visual analogue scale (VAS) on a Likert scale ranging from 0 (not stressed) to 9 (very stressed) at pre-baseline, post-baseline, pre-stress, mid stress, post-stress, pre-relaxation, post-relaxation, pre-recovery, post-recovery and in the evening of the day of laboratory testing 2. Relaxation ratings will be measured with a VAS on a Likert scale ranging from 0 (not relaxed) to 9 (very relaxed) at pre-baseline, post-baseline, pre-stress, mid stress, post-stress, pre-relaxation, post-relaxation, pre-recovery, post-recovery and in the evening of the day of laboratory testing

—

Secondary

Measure	Time frame
1. Heart rate variability measured with an electrocardiogram, analyzed using the Pan Tompkins algorithm, and estimated with the root mean square of successive differences (RMSSD) throughout baseline, stress, relaxation, and recovery 2. Tonic skin conductance level measured using galvanic skin conductance (GSR) recording and analyzed using Ledalab throughout baseline, stress, relaxation, and recovery 3. Number of phasic non-specific skin conductance responses measured using GSR recording and analyzed using Ledalab throughout baseline, stress, relaxation, and recovery 4 Systolic and diastolic blood pressure measured using an automated oscillometric blood pressure monitor at 1 min from the end of the baseline, stress, relaxation, and recovery phases 5. Respiratory rate measured using a respiration belt throughout baseline, stress, relaxation, and recovery 6. State mood measured using Der Mehrdimensionale Befindlichkeitsfragebogen (MDBF) questionnaire at pre-stress, post-stress, post-relaxation, and in the evening of the day of laboratory testing 7. State rumination measured using Der Response Styles Questionnaire (RSQ-D, adapted for state) at pre-stress, post-stress, post-relaxation, and in the evening of the day of laboratory testing 8. Post-event processing measured using Post-Event Processing Record (PEPR) questionnaire (translated to German) at post-relaxation and in the evening of the day of laboratory testing	—

Measure

Time frame

1. Heart rate variability measured with an electrocardiogram, analyzed using the Pan Tompkins algorithm, and estimated with the root mean square of successive differences (RMSSD) throughout baseline, stress, relaxation, and recovery 2. Tonic skin conductance level measured using galvanic skin conductance (GSR) recording and analyzed using Ledalab throughout baseline, stress, relaxation, and recovery 3. Number of phasic non-specific skin conductance responses measured using GSR recording and analyzed using Ledalab throughout baseline, stress, relaxation, and recovery 4 Systolic and diastolic blood pressure measured using an automated oscillometric blood pressure monitor at 1 min from the end of the baseline, stress, relaxation, and recovery phases 5. Respiratory rate measured using a respiration belt throughout baseline, stress, relaxation, and recovery 6. State mood measured using Der Mehrdimensionale Befindlichkeitsfragebogen (MDBF) questionnaire at pre-stress, post-stress, post-relaxation, and in the evening of the day of laboratory testing 7. State rumination measured using Der Response Styles Questionnaire (RSQ-D, adapted for state) at pre-stress, post-stress, post-relaxation, and in the evening of the day of laboratory testing 8. Post-event processing measured using Post-Event Processing Record (PEPR) questionnaire (translated to German) at post-relaxation and in the evening of the day of laboratory testing

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026