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

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.

Study Overview

• Status: Unknown
• Conditions: Stress
• Intervention / Treatment: Device: Use of virtual reality lenses, with relaxing audio-visual contents

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Valparaiso, Chile, 2340000
    • Recruiting
    • Blood and Tissue Center
    • Contact: Octavio Guzmán; Phone Number: +56961907508; Email: octavio.guzman@redsalud.gov.cl
    • Contact: Pedro Meneses; Phone Number: 322571678; Email: pedro.meneses@redsalud.gov.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Distractor; 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	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.
No Intervention: Traditional Blood Donation Process; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical scale of pain (EN)	Main measure for pain perception	Once finalized the donation that should last a maximum of 15 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Center for Blood and Tissues IV and V Region, Chile
• Investigators: Study Director: Pedro Meneses, Medical College of Chile

Publications and helpful links

General 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.
• Mahrer 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.

Study record dates

Study Major Dates

• Study Start: December 30, 2016
• Primary Completion (Actual): November 24, 2017
• Study Completion: November 24, 2017

Study Registration Dates

• First Submitted: June 18, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 24, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Virtual Reality; Intervention; Blood Donors; Stress Reduction; Needle Aspiration
• Other Study ID Numbers: ORD1083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Practice Guide

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No