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

NCT03202433 | Unknown DMC

• 1 other identifier: ORD1083
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Reduce stress associated with needle aspiration, in voluntary and replacement blood donors. This study has not been completed.

Conditions

Stress

Keywords

Virtual Reality; Stress Reduction; Needle Aspiration; Blood Donors; Intervention

Outcome Measures

Primary Outcomes (1)

• Numerical scale of pain (EN)

  Main measure for pain perception

  Once finalized the donation that should last a maximum of 15 minutes.

Secondary Outcomes (2)

• Heart rate. Measurement with automatic equipment

  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

  Before donating, after the puncture and after the extraction of the needle.Maximum duration of the procedure, 15 minutes

Study Arms (2)

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

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

Interventions

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

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

Virtual Reality Distractor

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center for Blood and Tissues IV and V Region, Chile: lead

Study Sites (1)

Blood and Tissue Center

Valparaíso, 2340000, Chile

RECRUITING

Related Publications (2)

• 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.

  PMID: 20543263 BACKGROUND

• 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.

  PMID: 19272275 BACKGROUND

Study Officials

• Pedro Meneses

  Medical College of Chile

  STUDY DIRECTOR

Central Study Contacts

Octavio Guzmán

CONTACT

+56961907508; octavio.guzman@redsalud.gov.cl

Francisco Rendich

CONTACT

+56945582922; frendich@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blocks swapped.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Technologist

Model Details: Allocation of two groups (Study and Control)

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 28, 2017
• Study Start: December 30, 2016
• Primary Completion: November 24, 2017
• Study Completion: November 24, 2017
• Last Updated: November 28, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)