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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality (VR) | Experimental | Type of intervention: Device (VR glasses) Description: Wearing virtual reality glasses with immersive video "Dali's Dreams" for 5 minutes |
|
| Deep Breathing (RP) | Experimental | Type of intervention: Procedure Description: Diaphragmatic deep breathing technique synchronized with venipuncture |
|
| Control Group (CG) | No Intervention | Standard venipuncture procedure without additional intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality viewer | Device | Participants wore virtual reality headsets with the immersive video 'DalÃ's Dreams,' a 360° audiovisual experience based on the surrealist work of Salvador DalÃ, lasting 5 minutes. The viewing began immediately before the venipuncture and continued throughout the procedure. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela de Medicina UAEH Campus Ramirez Ulloa | Pachuca | Hidalgo | 400 | Mexico |
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.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D001008 | Anxiety Disorders |
| D017060 | Patient Satisfaction |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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." |
|
| 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) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D010146 | Pain |