Clinical trial NCT06506760: Immersive VR for Female Orthopaedic Rehabilitation
Official title: The Impact of Immersive Virtual Reality Therapy on Psychological and Functional Status in Female Patients Undergoing Inpatient Rehabilitation Following Hip Arthroplasty: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthropathy
Keywords: virtual reality
arthroplasty
women
depression
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
name: Jan Dlugosz University in Czestochowa
First posted: 2024-07-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effects of cardiological rehabilitation enhanced with virtual reality (VR) versus conventional rehabilitation methods. It assesses the impact on both psychological parameters (including depression, stress, anxiety, and kinesiophobia) and physiological and functional parameters of cardiology patients. The aim is to analyze the efficacy and benefits of VR-supported rehabilitation in improving patients' mental and physical health compared to traditional methods.

Detailed description: The study will involve elderly female patients aged 60 and above who present sequentially at the Rehabilitation Department of St. Hedwig of Silesia Hospital in Trzebnica (Poland) within three months following hip joint arthroplasty surgery. Participants will be randomly assigned to one of two groups: Group A, the Virtual Reality Group, will receive 8 therapy sessions, with two sessions per week; Group B, the Control Group, will undergo conventional rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Female individuals who have recently undergone hip joint arthroplasty surgeries aged 60 years and above.

Exclusion Criteria:

* cognitive impairments that prevent independent completion of research questionnaires
* reported consciousness disorders
* bipolar affective disorder and other serious mental disorders in the patient's medical history
* use of psychoactive drugs
* ongoing psychiatric treatment or individual psychological therapy
* contraindications to Virtual Reality such as epilepsy, vertigo, serious vision disorders
* functional status preventing independent movement (orthopedic aids are allowed, e.g., crutches, walker)
* refusal to participate in the study at any stage

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline and 4 weeks
measure: Generalized Self-Efficacy Scale
timeFrame: Baseline and 4 weeks
measure: Barthel Index
timeFrame: Baseline and 4 weeks
measure: Rivermead Mobility Index
timeFrame: Baseline and 4 weeks
measure: Tinetti's Short Scale
timeFrame: Baseline and 4 weeks
measure: Short Physical Performance Battery
timeFrame: Baseline and 4 weeks
measure: Perception of Stress Questionnaire
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Trzebnica
country: Poland
facility: St. Hedwig of Silesia Hospital
state: Lower Silesia
Study officials:
affiliation: Wroclaw Medical University
name: Justyna Mazurek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wrocław University of Health and Sport Sciences
name: Joanna Szczepańska-Gieracha, Professor
role: STUDY_CHAIR
affiliation: Gajda-Med District Hospital in Pułtusk
name: Robert Gajda, PhD
role: STUDY_CHAIR
References:
citation: Cieslik B, Mazurek J, Rutkowski S, Kiper P, Turolla A, Szczepanska-Gieracha J. Virtual reality in psychiatric disorders: A systematic review of reviews. Complement Ther Med. 2020 Aug;52:102480. doi: 10.1016/j.ctim.2020.102480. Epub 2020 Jun 9.
citation: Szczepanska-Gieracha J, Cieslik B, Rutkowski S, Kiper P, Turolla A. What can virtual reality offer to stroke patients? A narrative review of the literature. NeuroRehabilitation. 2020;47(2):109-120. doi: 10.3233/NRE-203209.
citation: Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.
citation: Wrzeciono A, Cieslik B, Kiper P, Szczepanska-Gieracha J, Gajda R. Exploratory analysis of the effectiveness of virtual reality in cardiovascular rehabilitation. Sci Rep. 2024 Jan 2;14(1):281. doi: 10.1038/s41598-023-50788-9.
citation: Mazurek J, Cieslik B, Wrzeciono A, Gajda R, Szczepanska-Gieracha J. Immersive Virtual Reality Therapy Is Supportive for Orthopedic Rehabilitation among the Elderly: A Randomized Controlled Trial. J Clin Med. 2023 Dec 14;12(24):7681. doi: 10.3390/jcm12247681.