- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06922838
The Effectiveness of a Virtual Reality-based Multisensory Intervention
Effectiveness of a Virtual Reality-based Multisensory Intervention for Postoperative Recovery in Patients Receiving Gynecological Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shirong Fang, M.D
- Phone Number: 15094947165
- Email: fsr0536@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: 1) significant postoperative pain response (VAS score over 4); 2) age greater than 18 years and volunteered to participate in this study.
Exclusion Criteria: 1) patients with psychosomatic disorders such as delirium, schizophrenia, and bipolar disorder; 2) patients with epilepsy, motion sickness, lightsensitivity, or other neurological diseases may have difficulty wearing the VR headset; 3) patients have severe heart, liver, kidney, blood, digestive, and nervous diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: VR-Aromatherapy group
The VR-Aromatherapy group received virtual reality intervention combined with aromatherapy for 20 minutes postoperatively.
The intervention was started by an investigator from the return of the patient to the ward.
|
The head-mounted virtual reality device is used to provide patients with relaxing videos of nature scenes accompanied by calming music and guided meditations.
Other Names:
The cotton ball soaked in lavender essential oil is placed near the patient's pillow.
|
Other: Aromatherapy group
The Aromatherapy group received lavender aromatherapy for 20 minutes postoperatively.
The intervention was started by an investigator from the return of the patient to the ward.
|
The cotton ball soaked in lavender essential oil is placed near the patient's pillow.
|
Other: VR group
The VR group received virtual reality intervention for 20 minutes postoperatively.
The intervention was started by an investigator from the return of the patient to the ward.
|
The head-mounted virtual reality device is used to provide patients with relaxing videos of nature scenes accompanied by calming music and guided meditations.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain response
Time Frame: The pain response of patients was assessed at 0.5 hour, 3 hour, 6 hour, 12 hour, 24 hour postoperatively, and immediately after intervention.
|
The Visual Analog Scale (VAS) scale was used to assess the pain response of patients.
|
The pain response of patients was assessed at 0.5 hour, 3 hour, 6 hour, 12 hour, 24 hour postoperatively, and immediately after intervention.
|
Anxiety
Time Frame: The anxiety level of patients was assessed immediately after the intervention.
|
The Beck Anxiety Inventory (BAI) scale was used to assess the anxiety of patients.
|
The anxiety level of patients was assessed immediately after the intervention.
|
Sleep quality
Time Frame: The sleep quality of patients was assessed at 24 hour postoperatively.
|
The Pittsburgh Sleep Quality Index (PSQI) scale was used to assess the postoperative sleep quality of patients.
|
The sleep quality of patients was assessed at 24 hour postoperatively.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jiang Liu, M.D, Weifang Medical University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025YX406
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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