NCT07027228

Brief Summary

Blood is considered a limited resource in health centers and blood and blood products must be kept ready. The COVID-19 pandemic has caused a significant decrease in life-saving blood donations. In addition, negative experiences such as vasovagal reactions, painful needle sticks, psychological triggers and injuries that develop during blood donation cause donors to experience anxiety, negatively affecting their vital signs and the next donation experience. Therefore, donors should be supported by distraction techniques during blood donation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

17 days

First QC Date

May 26, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

blood donationvirtual realitymusicanxietyvital signsdonor satisfaction

Outcome Measures

Primary Outcomes (6)

  • State and Trait Anxiety Scale

    The State and Trait Anxiety Scale is one of the scales frequently used in measuring anxiety. The scale consists of two parts: a 20-item "state anxiety form" and a 20-item "trait anxiety form". Individuals are asked to answer four-point Likert items (1: not at all, 2: a little, 3: a lot of the time, 4: completely) to determine what they are feeling at that moment. Since this study aims to measure donors' anxiety levels before and after blood donation, the state anxiety measuring part of the scale will be used. The scores obtained from the scale vary between 20 and 80. Although there is no anxiety threshold on the scale, a high score indicates a high anxiety level, and a low score indicates a low anxiety level.

    Up to two months

  • Blood pressure

    Individuals' blood pressure values will be determined with a sphygmomanometer.

    Up to two months

  • Pulse

    Individuals' pulse values will be determined by measuring with a pulse oximeter.

    Up to two months

  • Oxygen saturation

    Individuals' oxygen levels will be determined by measuring with a pulse oximeter.

    Up to two months

  • Respiratory

    The ventilation value of the individuals will be measured and recorded from the anterior thorax for one minute.

    Up to two months

  • Satisfaction Scale

    It is an evaluation form consisting of five statements (5: Very satisfied, 4: Satisfied, 3: Undecided, 2: Not satisfied, 1: Not satisfied at all) to determine donors' satisfaction with the virtual reality glasses and music application. An increase in the score indicates an increase in satisfaction.

    Up to two months

Study Arms (3)

Virtual reality glasses group

EXPERIMENTAL

This is the group where anxiety, vital signs and donor satisfaction will be evaluated using virtual reality glasses.

Other: Using virtual reality glasses or listening to music

Music group

EXPERIMENTAL

This is the group where anxiety, vital signs and donor satisfaction will be evaluated using a music application.

Other: Using listening to music

Control group

NO INTERVENTION

This is the group where anxiety, vital signs and donor satisfaction will be evaluated without any intervention.

Interventions

Donors in the intervention group will be randomly assigned and shown relaxing nature images through virtual reality glasses.

Virtual reality glasses group

Donors in the intervention group will be randomly assigned and will listen to relaxing music.

Music group

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-60,
  • Having a visual, hearing or perception disorder that prevents communication,
  • Having neurological, psychiatric or psychological diseases,
  • Donating whole blood.

You may not qualify if:

  • Having vasovagal reactions,
  • Having complaints such as migraine, vertigo, active nausea, vomiting, headache,
  • Not having the blood donation chair in the semi-fowler position throughout the application,
  • Wanting to leave the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Personal SatisfactionAnxiety Disorders

Condition Hierarchy (Ancestors)

BehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 18, 2025

Study Start

June 23, 2025

Primary Completion

July 10, 2025

Study Completion

July 23, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations