ViSu - Virtual Reality and Sound Intervention under Chemotherapy

Not Applicable

Recruiting

Conditions: Anxiety, cancer-related fear of progression
C50
C51
C52
C53
C54
C55
C56
C57
C58

Registration Number: DRKS00029738

Lead Sponsor: niversitätsklinikum Düsseldorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 82

Inclusion Criteria

Presence of a confirmed senological and/or gynecological cancer diagnosis
Intravenous chemotherapy with an application duration incl. irrigation of at least 60 minutes
At least the second chemotherapy session at the time of the intervention
Legal capacity
Minimum age = 18 years
Sufficient knowledge of the German language

Exclusion Criteria

Severe visual and/or hearing impairment.
Neurological/psychiatric pre-existing conditions affecting the vestibular organ, impairing the sense of balance or altering visual perception (e.g., Meniere's disease, dementia, post-stroke condition, psychosis)
known epilepsy
claustrophobia
Severe side effects during the first chemotherapy session (Therefore, study start is planned only from the second session)
Chemotherapy in the context of a study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
STAI-State (Staite-Trait-Anxiety Questionnaire, Spielberger et al., 1970), before and after intervention

Secondary Outcome Measures

Name	Time	Method
Physiological sympathetic stress response (heart rate/pulse via pulse oximeter in beats per minutes), HPA axis activity (salivary cortisol), progression anxiety (PA-F-KF; Mehnert et al., 2006), symptom distress (MIDOS-2; Stiel et al., 2010), anxiety via visual analog scale (0=not at all anxious to 100=maximally anxious), satisfaction (0=not at all satisfied to 100=maximally satisfied), self-efficacy expectancy via General Self-Efficacy Short Scale (ASKU; Beierlein et al., 2014), STAI-Trait (Grimm, 2009), Demographic & disease-related data (adapted from PO Bado, Herschbach et al., 2008), Experiences with mindfulness and music, Usability assessment (7 items from the PSSUQ, Lewis, 1995 & self-created items).