Gynecological DiseaseNCT06922838
The Effectiveness of a Virtual Reality-based Multisensory Intervention
A study testing Virtual Reality intervention and Aromatherapy in people with Gynecological Disease, run by Weifang Medical University.
Trial summary
This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Gynecological Disease
- What is being tested?
- Virtual Reality intervention and Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 6 Apr 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of a Virtual Reality-based Multisensory Intervention for Postoperative Recovery in Patients Receiving Gynecological Surgery
This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery.
Read the detailed description
This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery. The results of the study included postoperative pain response, comfort, and anxiety of the patients.
- Conditions
- Gynecological Disease
- Being tested
- Virtual Reality intervention, Aromatherapy
- Keywords
- Pain management, Virtual reality, Gynecology, Postoperative recovery
- Medical subject headings
- Genital Diseases, Female, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality interventionOther
Also called VR intervention
The head-mounted virtual reality device is used to provide patients with relaxing videos of nature scenes accompanied by calming music and guided meditations.
AromatherapyOther
The cotton ball soaked in lavender essential oil is placed near the patient's pillow.
| Study group | Role | What they receive |
|---|---|---|
| VR-Aromatherapy group | Other | 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. Receives: Other: Virtual Reality intervention; Other: Aromatherapy |
| Aromatherapy group | Other | 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. Receives: Other: Aromatherapy |
| VR group | Other | 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. Receives: Other: Virtual Reality intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response
The Visual Analog Scale (VAS) scale was used to assess the pain response of patients.
Measured: 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
The Beck Anxiety Inventory (BAI) scale was used to assess the anxiety of patients.
Measured: The anxiety level of patients was assessed immediately after the intervention.
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) scale was used to assess the postoperative sleep quality of patients.
Measured: The sleep quality of patients was assessed at 24 hour postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start6 Apr 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weifang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Liu, Weifang Medical University
- Investigators
- Jiang Liu, M.D, Principal investigator, Weifang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922838
- Sponsor's protocol ID
- 2025YX406
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu J, Liu Y, Bi L, Zhao L, Hu F, Huang M, Zhang J, Zhou X, Wang T, Fang S, Zhang F, Song Y. Effects of multisensory stimulation based on immersive virtual reality in postoperative neuropsychiatric recovery after gynecological laparoscopy. NPJ Digit Med. 2026 Mar 24;9(1):372. doi: 10.1038/s41746-026-02515-7.
PubMed 41872447
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Reality-based Multisensory Intervention for Postoperative Recovery in Patients Receiving Gynecological Surgery
- ClinicalTrials.gov ID
- NCT06922838
- Acronym / sponsor ID
- 2025YX406
- Conditions
- Gynecological Disease
- Keywords
- Pain management, Virtual reality, Gynecology, Postoperative recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Weifang Medical UniversityUniversity, hospital or other
- Study start
- 6 Apr 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery.
Detailed description
This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery. The results of the study included postoperative pain response, comfort, and anxiety of the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR-Aromatherapy group | Other | Other: Virtual Reality intervention, Other: AromatherapyThe 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. |
| Aromatherapy group | Other | Other: AromatherapyThe 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. |
| VR group | Other | Other: Virtual Reality interventionThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality interventionAlso: VR interventionThe head-mounted virtual reality device is used to provide patients with relaxing videos of nature scenes accompanied by calming music and guided meditations. | Other | VR group, VR-Aromatherapy group |
| AromatherapyThe cotton ball soaked in lavender essential oil is placed near the patient's pillow. | Other | Aromatherapy group, VR-Aromatherapy group |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 41872447Liu J, Liu Y, Bi L, Zhao L, Hu F, Huang M, Zhang J, Zhou X, Wang T, Fang S, Zhang F, Song Y. Effects of multisensory stimulation based on immersive virtual reality in postoperative neuropsychiatric recovery after gynecological laparoscopy. NPJ Digit Med. 2026 Mar 24;9(1):372. doi: 10.1038/s41746-026-02515-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiang Liu, M.D principal investigator
Weifang Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality intervention and Aromatherapy in people with Gynecological Disease, run by Weifang Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirong Fang, M.D (15094947165, fsr0536@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06922838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.