NCT04346732

Brief Summary

Aim: The aim of this study is to assess the effectiveness of vapocoolant spray in reducing pain related to venipuncture in young, healthy male blood donors. Hypotheses: H1: Vapocoolant spray reduces venipuncture pain during blood donation. H0: Vapocoolant spray does not reduce venipuncture pain during blood donation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 11, 2020

Last Update Submit

April 14, 2020

Conditions

Keywords

Vapocoolant SprayVenipuncturePainDonors

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in venipuncture pain on the Visual Analogue Scale(VAS) during blood donation

    The VAS is used to inquire about pain levels resulting from venipuncture.In the 10 cm-long VAS, 0 indicates no pain, while 10 indicates the most intense pain.

    immediately following venipuncture procedure

Study Arms (2)

Vapocoolant spray

EXPERIMENTAL

Vapocoolant spray was applied to the donors in the vapocoolant spray group.

Other: Vapocoolant spray

Control

NO INTERVENTION

The donors in the control group were not given any intervention during the blood collection process.

Interventions

Vapocoolant spray

Vapocoolant spray

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged between 18 and 35
  • BMI between 18.5 and 24.9 kg/m2
  • speaks turkish
  • male donor
  • individuals who applied to make voluntary blood donations
  • volunteers to participate in the study

You may not qualify if:

  • donors who did not agree to take part in the study,
  • donors with open wound, scar, infection, dermatitis, eczema or lesion at the venipuncture site, or donors with cold allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
In both groups, immediately following venipuncture, pain assessment was made with the VAS by the researcher, who did not know which group each participant belonged to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The participants were separated into two groups with the randomisation method.These groups were named the vapocoolant spray group and the control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 11, 2020

First Posted

April 15, 2020

Study Start

April 1, 2016

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

April 15, 2020

Record last verified: 2020-04