Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors

NCT ID: NCT04346732

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Venipuncture Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants were separated into two groups with the randomisation method.These groups were named the vapocoolant spray group and the control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
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 Groups

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Vapocoolant spray

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

Group Type EXPERIMENTAL

Vapocoolant spray

Intervention Type OTHER

Vapocoolant spray

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vapocoolant spray

Vapocoolant spray

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Semra Aciksoz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SAciksoz

Identifier Type: -

Identifier Source: org_study_id

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