Pain ManagementNCT07359729
Deep Breathing and Virtual Reality for Venipuncture Pain
A study testing Virtual reality viewer and Conscious breathing in people with Pain Management and Anxiety, run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Anxiety, Virtual Reality
- What is being tested?
- Virtual reality viewer and Conscious breathing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteMexico
- Study dates
- 6 Feb 2024to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65
- With the cognitive capacity to answer questionnaires
- Requiring venipuncture in the forearm
- Who agreed to participate voluntarily
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site
Escuela de Medicina UAEH Campus Ramirez Ulloa
Pachuca, Hidalgo, 400
About this study
Official title: "Deep Breathing Is More Effective Than Virtual Reality in Reducing Venipuncture Pain in Adults, With Comparable Effects on Anxiety: A Randomized Controlled Trial"
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.
Read the 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.
- Conditions
- Pain Management, Anxiety, Virtual Reality, Breathing Exercises, Pain Measurement, Patient Satisfaction
- Being tested
- Virtual reality viewer, Conscious breathing
- Keywords
- Acute pain, Pain management, Physiological parameters, Venipuncture, Procedure anxiety
- Medical subject headings
- Agnosia, Anxiety Disorders, Patient Satisfaction, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conscious breathingBehavioural
"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."
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) | Experimental | Type of intervention: Device (VR glasses) Description: Wearing virtual reality glasses with immersive video "Dali's Dreams" for 5 minutes Receives: Device: Virtual reality viewer |
| Deep Breathing (RP) | Experimental | Type of intervention: Procedure Description: Diaphragmatic deep breathing technique synchronized with venipuncture Receives: Behavioral: Conscious breathing |
| Control Group (CG) | No intervention | Standard venipuncture procedure without additional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-venipuncture (within the first 2 minutes after the procedure)
Secondary outcomes (2)
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.
Measured: Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-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
Measured: Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start6 Feb 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma del Estado de Hidalgo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Isidoro Ortiz Ramírez, Universidad Autónoma del Estado de Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359729
- Sponsor's protocol ID
- Folio: "232"/2024
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Deep Breathing Is More Effective Than Virtual Reality in Reducing Venipuncture Pain in Adults, With Comparable Effects on Anxiety: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07359729
- Acronym / sponsor ID
- Folio: "232"/2024
- Conditions
- Pain Management, Anxiety, Virtual Reality, Breathing Exercises, Pain Measurement, Patient Satisfaction
- Keywords
- Acute pain, Pain management, Physiological parameters, Venipuncture, Procedure anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Universidad Autónoma del Estado de HidalgoUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) | Experimental | Device: Virtual reality viewerType of intervention: Device (VR glasses) Description: Wearing virtual reality glasses with immersive video "Dali's Dreams" for 5 minutes |
| Deep Breathing (RP) | Experimental | Behavioral: Conscious breathingType of intervention: Procedure Description: Diaphragmatic deep breathing technique synchronized with venipuncture |
| Control Group (CG) | No intervention | –Standard venipuncture procedure without additional intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65
- With the cognitive capacity to answer questionnaires
- Requiring venipuncture in the forearm
- Who agreed to participate voluntarily
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality viewerParticipants 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. | Device | Virtual Reality (VR) |
| Conscious 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." | Behavioural | Deep Breathing (RP) |
Primary outcome
Pain Intensity During Venipuncture
Time frame: 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.
2 secondary outcomes
Procedure-related anxiety (VAS-A)
Time frame: Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)
Procedure-related anxiety (STAI-6)
Time frame: Before procedure (pre-venipuncture) and immediately after procedure (within 2 minutes post-venipuncture)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality viewer and Conscious breathing in people with Pain Management and Anxiety, run by Universidad Autónoma del Estado de Hidalgo at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity During Venipuncture (time frame: Immediately post-venipuncture (within the first 2 minutes after the procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.