Reduce Stress Associated With Needle Aspiration, in Voluntary and Replacement Blood Donors

Stress Clinical Trial

Official title:

Use of Virtual Reality in Blood Donors, an Innovative Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03202433
• Other study ID #: ORD1083
• Status: Recruiting
• Phase: N/A
• First received: June 18, 2017
• Last updated: November 24, 2017
• Start date: December 30, 2016
• Est. completion date: November 24, 2017

Study information

• Verified date: November 2017
• Source: Center for Blood and Tissues IV and V Region, Chile
• Contact: Octavio Guzmán
• Phone: +56961907508
• Email: octavio.guzman[@]redsalud.gov.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reduce stress associated with needle aspiration, in voluntary and replacement blood donors.

This study has not been completed.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 24, 2017
• Est. primary completion date: November 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Stress

Intervention

Device:
• Use of virtual reality lenses, with relaxing audio-visual contents
Use of virtual reality lenses (and audio) as a distraction for the blood donor patients.

Locations

Country	Name	City	State
Chile	Blood and Tissue Center	Valparaiso

Sponsors (1)

Lead Sponsor	Collaborator
Center for Blood and Tissues IV and V Region, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (2)

Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical scale of pain (EN)	Main measure for pain perception	Once finalized the donation that should last a maximum of 15 minutes.
Secondary	Heart rate. Measurement with automatic equipment	Measure for the perception of stress	Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes
Secondary	Blood pressure. Measurement with automatic equipment	Measure for the perception of stress	Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes