NCT06922838

Brief Summary

This study explores the effectiveness of a virtual reality-based multisensory intervention for postoperative recovery in patients receiving gynecological surgery.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 3, 2025

Last Update Submit

April 9, 2025

Conditions

Keywords

Pain managementVirtual realityGynecologyPostoperative recovery

Outcome Measures

Primary Outcomes (3)

  • Pain response

    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

    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

    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.

Study Arms (3)

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.

Other: Virtual Reality interventionOther: 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.

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.

Other: Virtual Reality intervention

Interventions

The head-mounted virtual reality device is used to provide patients with relaxing videos of nature scenes accompanied by calming music and guided meditations.

Also known as: VR intervention
VR groupVR-Aromatherapy group

The cotton ball soaked in lavender essential oil is placed near the patient's pillow.

Aromatherapy groupVR-Aromatherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study population was the patients undergoing gynecologic surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Genital Diseases, FemaleAgnosia

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jiang Liu, M.D

    Weifang Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirong Fang, M.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research investigator

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 11, 2025

Study Start

April 6, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

April 11, 2025

Record last verified: 2025-04