NCT07359729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

November 25, 2025

Last Update Submit

January 15, 2026

Conditions

Pain ManagementAnxietyVirtual RealityBreathing ExercisesPain MeasurementPatient Satisfaction

Keywords

Acute painPain managementPhysiological parametersVenipunctureProcedure anxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Procedure-related anxiety (VAS-A)

    Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)

  • Procedure-related anxiety (STAI-6)

    Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)

Study Arms (3)

Virtual Reality (VR)

EXPERIMENTAL

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

Device: Virtual reality viewer

Deep Breathing (RP)

EXPERIMENTAL

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

Behavioral: Conscious breathing

Control Group (CG)

NO INTERVENTION

Standard venipuncture procedure without additional intervention

Interventions

Virtual reality viewerDEVICE

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.

Virtual Reality (VR)
Conscious breathingBEHAVIORAL

"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."

Deep Breathing (RP)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escuela de Medicina UAEH Campus Ramirez Ulloa

Pachuca, Hidalgo, 400, Mexico

Location

MeSH Terms

Conditions

AgnosiaAnxiety DisordersPatient SatisfactionAcute Pain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehaviorPain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Science specializing in Pharmacology

Study Record Dates

First Submitted

November 25, 2025

First Posted

January 22, 2026

Study Start

February 6, 2024

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

ME(1)