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Trial record 7 of 705 for:    region | Chile

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

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ClinicalTrials.gov Identifier: NCT03202433
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Adrián Erich Goecke Varela, Center for Blood and Tissues IV and V Region, Chile

Brief Summary:

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

This study has not been completed.


Condition or disease Intervention/treatment Phase
Stress Device: Use of virtual reality lenses, with relaxing audio-visual contents Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation of two groups (Study and Control)
Masking: Single (Outcomes Assessor)
Masking Description: Blocks swapped.
Primary Purpose: Treatment
Official Title: Use of Virtual Reality in Blood Donors, an Innovative Tool
Study Start Date : December 30, 2016
Actual Primary Completion Date : November 24, 2017
Study Completion Date : November 24, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Numerical scale of pain (EN) [ Time Frame: Once finalized the donation that should last a maximum of 15 minutes. ]
    Main measure for pain perception


Secondary Outcome Measures :
  1. 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 ]
    Measure for the perception of stress

  2. 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 ]
    Measure for the perception of stress



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202433


Contacts
Contact: Octavio Guzmán +56961907508 octavio.guzman@redsalud.gov.cl
Contact: Francisco Rendich +56945582922 frendich@gmail.com

Locations
Chile
Blood and Tissue Center Recruiting
Valparaiso, Chile, 2340000
Contact: Octavio Guzmán    +56961907508    octavio.guzman@redsalud.gov.cl   
Contact: Pedro Meneses    322571678    pedro.meneses@redsalud.gov.cl   
Sponsors and Collaborators
Center for Blood and Tissues IV and V Region, Chile
Investigators
Study Director: Pedro Meneses Medical College of Chile

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Adrián Erich Goecke Varela, Medical Technologist, Center for Blood and Tissues IV and V Region, Chile
ClinicalTrials.gov Identifier: NCT03202433     History of Changes
Other Study ID Numbers: ORD1083
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adrián Erich Goecke Varela, Center for Blood and Tissues IV and V Region, Chile:
Virtual Reality
Stress Reduction
Needle Aspiration
Blood Donors
Intervention