The Efficacy of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Anxiety Preoperative

• Registration Number: NCT06961695
• Lead Sponsor: Babes-Bolyai University

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 Timeline

• Study First Submitted: 2025-04-16
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Study Start: 2025-05-12
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain Intensity Measured by Brief Pain Inventory (BPI) .	The BPI will be administered at three time points: preoperatively (Day 1 of hospitalization), postoperatively (Day 2, the day of surgery), and at follow-up (2 weeks after surgery).	This tool assesses both pain intensity and its impact on daily functioning (e.g., sleep, work, social interactions). The BPI consists of 9 items, each rated on a 0-10 scale, where 0 indicates no pain or interference and 10 represents the worst possible pain or interference.
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)	The NRS will be administered four times throughout the day following the surgery.	Participants will rate their pain intensity on a 0-10 scale, where 0 indicates no pain and 10 represents the worst imaginable pain. NRS assessments will be conducted at four postoperative time points. This approach helps minimize the influence of analgesics and anesthetics on reported pain levels. By spreading out the measurements, we reduce the risk that a single time point reflects only the temporary effects of medication, thus allowing for more reliable and valid comparisons between treatment groups.

Secondary Outcome Measures

Name	Time	Method
Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - State version (STAI-S)	STAI-S measures will be administered: Preoperative/Pre-intervention (Day 1 of hospitalization) Post-intervention (Day 1, within 15 minutes after the VR session), Postoperative (Day 2, day of surgery), Follow-up (2 weeks after surgery).	State-Trait Anxiety Inventory - state version (STAI-S) Measures state anxiety (how the participant feels "at this moment"). Contains 20 items rated on a 4-point Likert scale (from "Not at all" to "Very much").; The scores range between 20 (no anxiety) and 80 (high anxiety)
Change in Anxiety Levels Measured by State-Trait Anxiety Inventory - Trait version (STAI-T)	STAI-T will be administered preoperatively, on Day 1 of hospitalization.	The STAI-T measures trait anxiety, referring to how the participant generally feels. It consists of 20 items rated on a 4-point Likert scale, ranging from "Almost never" to "Almost always." Total scores range from 20 to 80, with higher scores indicating greater levels of anxiety.
Change in Anxiety Levels Measured by Hospital Anxiety and Depression Scale (HADS).	Preoperative/Pre-intervention (Day 1 of hospitalization) Postoperative (Day 2, day of surgery) Follow-up (2 weeks after surgery)	Hospital Anxiety and Depression Scale (HADS): Evaluates anxiety and depression symptoms in hospitalized patients. Consists of 14 items divided into two subscales (anxiety and depression), each rated from 0 (absent) to 3 (severe).; Total anxiety scores range from: 0-7 (normal) 8-10 (borderline abnormal) 11-21 (abnormal)