Anxiety, Breathing Exercises, Pain Management, Pain Measurement, Patient Satisfaction, Virtual Reality
Conditions
Keywords
Acute pain, Pain management, Physiological parameters, Venipuncture, Procedure anxiety
Brief 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.
Interventions
DEVICEVirtual 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.
BEHAVIORALConscious 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."
Sponsors
Universidad Autónoma del Estado de Hidalgo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed