Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT06961695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2025-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients
Sponsor:
Babes-Bolyai University
Organization:
Study Overview
Official Title:
Assessing the Effectiveness of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients: A Controlled Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-MindPain
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: