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:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT06961695
Brief Summary:
The goal of this randomized clinical trial is to evaluate whether a virtual reality (VR) mindfulness intervention can reduce anxiety and postoperative pain in adults undergoing surgery, primarily hernia and varicose vein procedures.
The main research questions are:
* Does a preoperative VR mindfulness intervention reduce anxiety before surgery?
* Does this reduction in anxiety result in lower postoperative pain compared to usual care?
* Does the intervention help prevent chronic pain two weeks after surgery? Researchers will compare a VR mindfulness intervention group with a treatment-as-usual (TAU) group to assess the intervention's effectiveness.
Participants will:
* Be randomly assigned to one of two groups:
* Experimental group: Receive a VR mindfulness session on the first day of hospitalization (one day before surgery).
* Control group: Receive standard hospital care (no intervention).
* Complete psychological and pain assessments at four time points:
1. Before the intervention (Day 1)
2. Immediately after the intervention (only the experimental group, Day 1)
3. After surgery (Day 2)
4. Two weeks after surgery (follow-up)
* Report pain intensity using the Numeric Rating Scale (NRS) at four postoperative time points.
Before enrollment, participants will undergo a structured interview to assess eligibility.
This study aims to determine whether reducing preoperative anxiety through VR mindfulness contributes to improved pain management and a lower risk of developing chronic pain following surgery.
Detailed Description:
Study Objective:
This study aims to assess the efficacy of a virtual reality (VR)-based mindfulness relaxation intervention in reducing preoperative anxiety, postoperative pain, and the risk of chronic pain two weeks after surgery.
Study Design:
This is a randomized controlled trial (RCT) comparing two groups:
1. Experimental Group - Participants will receive a VR mindfulness-based relaxation intervention prior to surgery.
2. Control Group - Participants will receive treatment as usual (TAU), with no additional intervention.
Intervention:
The VR mindfulness-based relaxation program will be administered on the day of hospitalization, one day prior to surgery.
The session will last 10-15 minutes and includes:
* A guided mindfulness exercise focused on breath awareness and relaxation.
* A virtual beach environment designed to enhance calm and reduce anxiety.
* A brief debriefing session following the second VR exposure (if applicable).
Assessments and Outcome Measures:
Structured psychological and pain assessments will be conducted at four time points:
1. Before the intervention (Day 1)
2. Immediately after the intervention (Day 1)
3. After surgery (Day 2)
4. Two weeks after surgery (follow-up)
Data Analysis:
* A Multivariate Analysis of Variance (MANOVA) with a mixed design (within-between interaction) will be used to assess differences across multiple dependent variables.
* Repeated measures MANOVA will be applied to examine longitudinal changes and interactions between time and group.
Expected Impact:
This study seeks to determine whether reducing preoperative anxiety through a VR mindfulness intervention improves postoperative pain management and reduces the likelihood of developing chronic pain. If effective, the intervention could be integrated into routine preoperative care protocols to enhance patient outcomes and overall recovery experiences.
Study:
NCT06961695
Study Brief:
Protocol Section:
NCT06961695