Deep Breathing and Virtual Reality for Venipuncture Pain

Universidad Autónoma del Estado de Hidalgo

Status: Completed

Conditions: Patient Satisfaction; Pain Management; Pain Measurement; Breathing Exercises; Anxiety; Virtual Reality

Treatments: Behavioral: Conscious breathing; Device: Virtual reality viewer

Study type: Interventional

Funder types: Other

Identifiers

NCT07359729

Folio: "232"/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 3 patient groups

Virtual Reality (VR)

Experimental group

Description:

Type of intervention: Device (VR glasses) Description: Wearing virtual reality glasses with immersive video "Dali's Dreams" for 5 minutes

Treatment:

Device: Virtual reality viewer

Deep Breathing (RP)

Experimental group

Description:

Type of intervention: Procedure Description: Diaphragmatic deep breathing technique synchronized with venipuncture

Treatment:

Behavioral: Conscious breathing

Control Group (CG)

No Intervention group

Description:

Standard venipuncture procedure without additional intervention