Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT04346732
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2020-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants were separated into two groups with the randomisation method.These groups were named the vapocoolant spray group and the control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2020-04-11', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in venipuncture pain on the Visual Analogue Scale(VAS) during blood donation', 'timeFrame': 'immediately following venipuncture procedure', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vapocoolant Spray', 'Venipuncture', 'Pain', 'Donors'], 'conditions': ['Venipuncture', 'Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nHypotheses:\n\nH1: Vapocoolant spray reduces venipuncture pain during blood donation. H0: Vapocoolant spray does not reduce venipuncture pain during blood donation.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 18 and 35\n* BMI between 18.5 and 24.9 kg/m2\n* speaks turkish\n* male donor\n* individuals who applied to make voluntary blood donations\n* volunteers to participate in the study\n\nExclusion Criteria:\n\n* donors who did not agree to take part in the study,\n* donors with open wound, scar, infection, dermatitis, eczema or lesion at the venipuncture site, or donors with cold allergy'}, 'identificationModule': {'nctId': 'NCT04346732', 'briefTitle': 'Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors', 'orgStudyIdInfo': {'id': 'SAciksoz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vapocoolant spray', 'description': 'Vapocoolant spray was applied to the donors in the vapocoolant spray group.', 'interventionNames': ['Other: Vapocoolant spray']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The donors in the control group were not given any intervention during the blood collection process.'}], 'interventions': [{'name': 'Vapocoolant spray', 'type': 'OTHER', 'description': 'Vapocoolant spray', 'armGroupLabels': ['Vapocoolant spray']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Semra Aciksoz', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}