Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors

Pain Clinical Trial

Official title:

Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346732
• Other study ID #: SAciksoz
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2020
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Venipuncture

Intervention

Other:
• Vapocoolant spray
Vapocoolant spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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