StressNCT03202433
Reduce Stress Associated With Needle Aspiration, in Voluntary and Replacement Blood Donors
A study testing Use of virtual reality lenses, with relaxing audio-visual contents in people with Stress, run by Center for Blood and Tissues IV and V Region, Chile at 1 site in Chile.
Trial summary
Reduce stress associated with needle aspiration, in voluntary and replacement blood donors. This study has not been completed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Use of virtual reality lenses, with relaxing audio-visual contents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChile
- Study dates
- 30 Dec 2016to 24 Nov 2017
- 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
- Able to understand and / or visualize the numerical scale of pain
- Spanish spoken
- Greater than 50 Kilograms of weight
- Blood hemoglobin: Greater than 12.5 g% in women and greater than 13.5 g% in men
- Have been accepted as a blood donor.
Who cannot join
- Unable to understand and / or visualize the numerical scale of pain
- Does not speak Spanish
- Less than 50 Kilograms
- Blood hemoglobin: Less than 12.5 g% in women and less than 13.5 g% in men.
- Have been rejected as a blood donor.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Blood and Tissue Center
Valparaíso, 2340000
Octavio Guzmán, +56961907508, octavio.guzman@redsalud.gov.cl
Pedro Meneses, 322571678, pedro.meneses@redsalud.gov.cl
About this study
Official title: Use of Virtual Reality in Blood Donors, an Innovative Tool
Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.
This study has not been completed.
Read the detailed description
The purpose of the study is to investigate the effectiveness of Virtual Reality (as a form of distraction) to reduce the stress associated with extraction needle puncture in the volunteer blood donors and reposition of Fixed Collection of the Valparaiso Blood Center, Of the Valparaíso San Antonio Health Service.
- Conditions
- Stress
- Being tested
- Use of virtual reality lenses, with relaxing audio-visual contents
- Keywords
- Virtual Reality, Stress Reduction, Needle Aspiration, Blood Donors, Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of virtual reality lenses, with relaxing audio-visual contentsDevice
Use of virtual reality lenses (and audio) as a distraction for the blood donor patients.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Distractor | Experimental | The objective is to apply a technique, using virtual reality lenses, with relaxing audio-visual contents of no more than ten minutes, to reduce stress before and during the blood donation process and to respond to the level of pain perceived during donation, either post-puncture and withdrawal of the needle Receives: Device: Use of virtual reality lenses, with relaxing audio-visual contents |
| Traditional Blood Donation Process | No intervention | The objective is to respond to the level of pain perceived during donation, either post-puncture and withdrawal of the needle, without virtual reality support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical scale of pain (EN)
Main measure for pain perception
Measured: Once finalized the donation that should last a maximum of 15 minutes.
Secondary outcomes (2)
Heart rate. Measurement with automatic equipment
Measure for the perception of stress
Measured: Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes
Blood pressure. Measurement with automatic equipment
Measure for the perception of stress
Measured: Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start30 Dec 2016
- Primary completion24 Nov 2017
- Study completion24 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation of two groups (Study and Control)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Blood and Tissues IV and V Region, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Erich Goecke Varela, Center for Blood and Tissues IV and V Region, Chile
- Investigators
- Pedro Meneses, Study director, Medical College of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202433
- Sponsor's protocol ID
- ORD1083
- Status last verified
- Nov 2017
- First submitted
- 18 Jun 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riva G, Raspelli S, Pallavicini F, Grassi A, Algeri D, Wiederhold BK, Gaggioli A. Interreality in the management of psychological stress: a clinical scenario. Stud Health Technol Inform. 2010;154:20-5.
PubMed 20543263Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
PubMed 19272275
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality in Blood Donors, an Innovative Tool
- ClinicalTrials.gov ID
- NCT03202433
- Acronym / sponsor ID
- ORD1083
- Conditions
- Stress
- Keywords
- Virtual Reality, Stress Reduction, Needle Aspiration, Blood Donors, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Center for Blood and Tissues IV and V Region, ChileUniversity, hospital or other
- Study start
- 30 Dec 2016
- Primary completion
- 24 Nov 2017 (actual)
- Study completion
- 24 Nov 2017
- First posted
- 28 Jun 2017 (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.
Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.
This study has not been completed.
Detailed description
The purpose of the study is to investigate the effectiveness of Virtual Reality (as a form of distraction) to reduce the stress associated with extraction needle puncture in the volunteer blood donors and reposition of Fixed Collection of the Valparaiso Blood Center, Of the Valparaíso San Antonio Health Service.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation of two groups (Study and Control)
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Distractor | Experimental | Device: Use of virtual reality lenses, with relaxing audio-visual contentsThe objective is to apply a technique, using virtual reality lenses, with relaxing audio-visual contents of no more than ten minutes, to reduce stress before and during the blood donation process and to respond to the level of pain perceived during donation, either post-puncture and withdrawal of the needle |
| Traditional Blood Donation Process | No intervention | –The objective is to respond to the level of pain perceived during donation, either post-puncture and withdrawal of the needle, without virtual reality support |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and / or visualize the numerical scale of pain
- Spanish spoken
- Greater than 50 Kilograms of weight
- Blood hemoglobin: Greater than 12.5 g% in women and greater than 13.5 g% in men
- Have been accepted as a blood donor.
Key exclusion criteria (5 listed)
- Unable to understand and / or visualize the numerical scale of pain
- Does not speak Spanish
- Less than 50 Kilograms
- Blood hemoglobin: Less than 12.5 g% in women and less than 13.5 g% in men.
- Have been rejected as a blood donor.
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 |
|---|---|---|
| Use of virtual reality lenses, with relaxing audio-visual contentsUse of virtual reality lenses (and audio) as a distraction for the blood donor patients. | Device | Virtual Reality Distractor |
Primary outcome
Numerical scale of pain (EN)
Time frame: Once finalized the donation that should last a maximum of 15 minutes.
Main measure for pain perception
2 secondary outcomes
Heart rate. Measurement with automatic equipment
Time frame: Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes
Blood pressure. Measurement with automatic equipment
Time frame: Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Background: PubMed 20543263Riva G, Raspelli S, Pallavicini F, Grassi A, Algeri D, Wiederhold BK, Gaggioli A. Interreality in the management of psychological stress: a clinical scenario. Stud Health Technol Inform. 2010;154:20-5.
- Background: PubMed 19272275Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
- Individual participant dataSharing planned: No
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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.
Pedro Meneses study director
Medical College of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of virtual reality lenses, with relaxing audio-visual contents in people with Stress, run by Center for Blood and Tissues IV and V Region, Chile at 1 site in Chile.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Nov 2017. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Octavio Guzmán (+56961907508, octavio.guzman@redsalud.gov.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical scale of pain (EN) (time frame: Once finalized the donation that should last a maximum of 15 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202433, which also lists 2 linked publications.
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 28 Nov 2017; AzTrials last refreshed its copy on 5 Nov 2026.