NCT07359729

Deep Breathing and Virtual Reality for Venipuncture Pain

"Deep Breathing Is More Effective Than Virtual Reality in Reducing Venipuncture Pain in Adults, With Comparable Effects on Anxiety: A Randomized Controlled Trial"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Universidad Autónoma del Estado de Hidalgo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the efficacy of two non-pharmacological techniques-virtual reality (VR) and deep breathing (DB)-in reducing pain and anxiety during venipuncture in adults. A total of 264 participants will be randomly assigned to use VR, practice DB, or receive the standard procedure (control group). Pain intensity will be measured using a Visual Analog Scale (VAS) immediately after venipuncture. Anxiety will be assessed using a VAS for anxiety and the 6-item State-Trait Anxiety Inventory (STAI-6). Physiological parameters (blood pressure and heart rate) will also be recorded. The study aims to determine which technique is more effective for pain and anxiety reduction, and to assess participant satisfaction and safety.

Detailed description

Objective To evaluate and compare the efficacy of virtual reality (VR) and deep breathing (DB) as non-pharmacological techniques for reducing pain and anxiety during venipuncture in adult participants. Background Venipuncture is one of the most frequent medical procedures and a significant source of pain and anticipatory anxiety for patients. While non-pharmacological interventions such as virtual reality and deep breathing have shown positive results in previous studies, comparative evidence of their efficacy in adult populations, particularly in Latin American contexts, remains scarce. Methods This is a randomized controlled trial with three parallel groups. A total of 264 adult participants will be randomly assigned to: 1) VR group (n=72), 2) DB group (n=76), or 3) Control group (n=116). The intervention will be administered during the venipuncture procedure. Pain intensity will be measured using a Visual Analog Scale (VAS) immediately after venipuncture. Anxiety will be assessed using both a VAS for anxiety and the 6-item State-Trait Anxiety Inventory (STAI-6) before and after the procedure. Physiological parameters (blood pressure and heart rate) will be recorded at rest and immediately after venipuncture. Data will be analyzed using Analysis of Covariance (ANCOVA) adjusted for age and non-parametric tests as appropriate. Outcomes The primary outcome is pain intensity during venipuncture. Secondary outcomes include anxiety levels, physiological parameters, and participant satisfaction with the intervention.

Conditions

• Pain Management
• Anxiety
• Virtual Reality
• Breathing Exercises
• Pain Measurement
• Patient Satisfaction

Interventions

Type	Name	Description
DEVICE	Virtual reality viewer	Participants wore virtual reality headsets with the immersive video 'Dalí's Dreams,' a 360° audiovisual experience based on the surrealist work of Salvador Dalí, lasting 5 minutes. The viewing began immediately before the venipuncture and continued throughout the procedure.
BEHAVIORAL	Conscious breathing	"Participants were instructed and supervised in a deep diaphragmatic breathing technique that consisted of: 1) Maximum nasal inhalation, 2) Holding the breath for 5-10 seconds, and 3) Controlled and complete exhalation. Breathing was performed in sync with the moment of venipuncture."

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-03-28
• Completion: 2025-03-28
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: Mexico