Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors

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.

Study Overview

• Status: Completed
• Conditions: Pain; Venipuncture
• Intervention / Treatment: Other: Vapocoolant spray

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent. Before the procedure was begun, the donors who agreed to participate in the study were met face-to-face and asked to fill in the "Informative Characteristics Form", the "VAS", the "Blood/Injection Fear Scale" and the "STAI-I" forms.Then the donors were assigned to their groups by the researcher.The donors in the control group were not given any intervention during the blood collection process. Vapocoolant spray was applied to the donors in the vapocoolant spray group. During the blood collection procedure, after the donors' skin was cleaned with antiseptic solution, spray was applied to the application site for a maximum of 10-15 seconds from a distance of 25 cm. 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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vapocoolant spray; Vapocoolant spray was applied to the donors in the vapocoolant spray group.	Other: Vapocoolant spray; Vapocoolant spray
No Intervention: Control; The donors in the control group were not given any intervention during the blood collection process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: April 11, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Venipuncture; Donors; Vapocoolant Spray
• Other Study ID Numbers: SAciksoz

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No