Deep Breathing and Virtual Reality for Venipuncture Pain

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.

• Virtual reality viewer (Device): 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.
• Conscious breathing (Behavioral): "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."

Primary outcomes

• Pain Intensity During Venipuncture [Immediately post-venipuncture (within the first 2 minutes after the procedure)]: 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.

Secondary outcomes

• Procedure-related anxiety (VAS-A) [Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)]: 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.
• Procedure-related anxiety (STAI-6) [Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)]: Anxiety measured using 6-item State-Trait Anxiety Inventory (STAI-6), scored from 6 to 24 points. Higher scores indicate greater state anxiety

Sex: All, ages: 18 Years to 65 Years, 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