Administrative information
Title {1} | Facilitating relaxation and stress reduction in healthy participants through a virtual reality intervention: study protocol for a non-inferiority randomized controlled trial |
Trial registration {2a and 2b}. | Retrospectively registered with ISRCTN Registry (Trial ID: ISRCTN11162338, https://www.isrctn.com/ISRCTN11162338) on January 22, 2021. |
Protocol version {3} | Issue date: 5th April, 2022, Protocol Version: 2.0 Revision chronology: - Original version V1.0: 15th March, 2021 Amendment 01: 5th April, 2022. We restructured our manuscript according to the Trials structured study protocol template and included missing information on SPIRIT items as requested by the reviewers. We adjusted the power analysis for the non-inferiority design. |
Funding {4} | This work is funded by the Bundesministerium für Bildung und Forschung (BMBF, Funding number: 16SV8068). |
Author details {5a} | Miriam Kampa1, 2, *, Johannes Finke1, Tobias Stalder1, Leandra Bucher1, Holger Klapperich3, Fabian Mertl4, Christian Zimmer4, Christian Geiger4, Marc Hassenzahl3, Tim Klucken1 1Department of Clinical Psychology and Psychotherapy, University of Siegen, Obergraben 23, 57072 Siegen, Germany;2Bender Institute of Neuroimaging, Justus Liebig University, Giessen, Otto-Behaghel-Str.10H, 35394 Giessen, Germany;3Ubiquitous Design/Experience and Interaction, University of Siegen, Kohlbettstraße 15, 57072 Siegen, Germany;4Mixed Reality and Visualization (MIREVI), Faculty of Media, University of Applied Sciences Düsseldorf [M1], Münsterstraße 156, 40476 Düsseldorf, Germany; *Corresponding author: Miriam Kampa (miriam.kampa@uni-siegen.de) MK and TK designed the study and wrote the manuscript. MK prepared all the materials and instructions for the data acquisition. JF and TS supported the technical side of the data acquisition. LB programmed the online questionnaires. HK developed the narrative and the design of the rationale for the VR. FM and CNZ programmed the VR. CG and MH are supervisors who contributed to the development of the VR. MH obtained the grant. All authors have made contributions to the design of the study and writing of the manuscript and have read and approved the final version of the manuscript. No professional writers have been involved. |
Name and contact information for the trial sponsor {5b} | Bundesministerium für Bildung und Forschung (BMBF), VDI/VDE Innovation + Technik GmbH, Alexander ReissSteinplatz 1, 10623 Berlin, Germany, Tel.: +49 30 310078-268, alexander.reiss@vdivde-it.de, www.vdivde-it.de. |
Role of sponsor {5c} | The funding source was not involved in the study design; the collection, analysis, and interpretation of the data; the writing of the report; or the decision to submit the article for publication. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Enrollment | Allocation | Study period | ||||||
---|---|---|---|---|---|---|---|---|
Pre | Intervention | Post | ||||||
Time point | -t1 | 0 | t1 | t2 | t3 | t4 | t5 | t6 |
Enrollment | ||||||||
Eligibility screen | X | |||||||
Informed consent | X | |||||||
Allocation | X | |||||||
Interventions | ||||||||
Stress induction | X | |||||||
VR relaxation | X | |||||||
Freely chosen relaxation | X | |||||||
Assessments | ||||||||
Self-report measures | ||||||||
Depression, anxiety, and stress | X | |||||||
Chronic stress | X | |||||||
Trait rumination | X | |||||||
Perceived stress | X | |||||||
Self-efficacy | X | |||||||
Mindful attention and awareness | X | |||||||
State stress | X | X | X | X | X | |||
State relaxation | X | X | X | X | X | |||
State mood | X | X | X | X | ||||
State rumination | X | X | X | X | ||||
Post-event processing | X | X | ||||||
Sense of presence in VR | X | |||||||
Physiological data | ||||||||
Heart rate | X | X | X | X | ||||
Heart rate variability | X | X | X | X | ||||
Tonic skin conductance level | X | X | X | X | ||||
Phasic skin conductance responses | X | X | X | X | ||||
Respiration rate | X | X | X | X | ||||
Systolic and diastolic blood pressure | X | X | X | X |