Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 4:32 AM
Ignite Modification Date: 2025-12-25 @ 4:32 AM
NCT ID: NCT06446518
Brief Summary: In this randomized control trial, investigators would like to assess as primary objective the effectiveness of VR in anxiolysis via using State Trait Anxiety- Inventory test various time during the perioperative period with recorded physiologic data. As a secondary objective they are investigating the use of VR in the postoperative period for pain modulation via using pain numeric rating scales (NRS), monitoring physiologic data, and collecting information on painkiller demand of the patients.
Detailed Description: This prospective, randomized controlled trial will be conducted with participants from the Paediatric Center, Semmelweis University, a tertiary level health care centre based in Budapest, Hungary. We evaluate the effects of VR immersion on reducing perioperative anxiety and postoperative pain. Participants will be asked to wear a VR headset for preferably an hour before and after the surgery. Patients will be asked to fill out three anxiety tests meanwhile investigators will record their vital parameters (HR, RR, SpO2, BP): on admission, in the operating room and on the surgical ward on the day after surgery. In the first postoperative day vital parameters, analgesic demand and NRS score will be recorded to follow patients pain status. Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.
Study: NCT06446518
Study Brief:
Protocol Section: NCT06446518