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"

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Pain Management; Patient Satisfaction; Virtual Reality; Pain Measurement; Breathing Exercises
• Intervention / Treatment: Device: Virtual reality viewer; Behavioral: Conscious breathing

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.

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Hidalgo
    • Pachuca, Hidalgo, Mexico, 400
      • Escuela de Medicina UAEH Campus Ramirez Ulloa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18 to 65
• With the cognitive capacity to answer questionnaires
• Requiring venipuncture in the forearm
• Who agreed to participate voluntarily

Exclusion Criteria:

• Intolerance to virtual reality
• Uncorrectable visual or hearing impairments
• Alcohol or illegal drug use within the previous 12 hours
• Heart disease
• Chronic use of analgesics or anticoagulants
• Skin conditions at the puncture site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality (VR); Type of intervention: Device (VR glasses) Description: Wearing virtual reality glasses with immersive video "Dali's Dreams" for 5 minutes	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.
Experimental: Deep Breathing (RP); Type of intervention: Procedure Description: Diaphragmatic deep breathing technique synchronized with venipuncture	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."
No Intervention: Control Group (CG); Standard venipuncture procedure without additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity During Venipuncture	Pain intensity measured using a Visual Analog Scale (VAS), scored from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable". Higher scores indicate greater pain intensity.	Immediately post-venipuncture (within the first 2 minutes after the procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related anxiety (VAS-A)	Anxiety measured using Visual Analog Scale for Anxiety (VAS-A), scored from 0 to 10, where 0 = "no anxiety" and 10 = "worst anxiety imaginable". Higher scores indicate greater anxiety.	Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)
Procedure-related anxiety (STAI-6)	Anxiety measured using 6-item State-Trait Anxiety Inventory (STAI-6), scored from 6 to 24 points. Higher scores indicate greater state anxiety	Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)

Collaborators and Investigators

• Sponsor: Universidad Autónoma del Estado de Hidalgo

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pain management; Acute pain; Venipuncture; Physiological parameters; Procedure anxiety
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Anxiety Disorders; Acute Pain; Agnosia; Patient Satisfaction
• Other Study ID Numbers: Folio: "232"/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared to protect patient confidentiality and privacy, in accordance with local data protection regulations and the guidelines of the ethics committee that approved the study. Aggregated information and study results will be made available through scientific publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No