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

NCT ID: NCT03202433

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-30

Study Completion Date

2017-11-24

Brief Summary

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

This study has not been completed.

Detailed Description

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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

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Stress

Keywords

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Virtual Reality Stress Reduction Needle Aspiration Blood Donors Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Allocation of two groups (Study and Control)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blocks swapped.

Study Groups

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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

Group Type EXPERIMENTAL

Use of virtual reality lenses, with relaxing audio-visual contents

Intervention Type DEVICE

Use of virtual reality lenses (and audio) as a distraction for the blood donor patients.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Blood and Tissues IV and V Region, Chile

OTHER

Sponsor Role lead

Responsible Party

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Adrián Erich Goecke Varela

Medical Technologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro Meneses

Role: STUDY_DIRECTOR

Medical College of Chile

Locations

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Blood and Tissue Center

Valparaíso, , Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Octavio Guzmán

Role: CONTACT

Phone: +56961907508

Email: [email protected]

Francisco Rendich

Role: CONTACT

Phone: +56945582922

Email: [email protected]

Facility Contacts

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Octavio Guzmán

Role: primary

Pedro Meneses

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 20543263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19272275 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Clinical Practice Guide

View Document

Other Identifiers

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ORD1083

Identifier Type: -

Identifier Source: org_study_id