Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-03-12 @ 1:05 AM
Study NCT ID:
NCT06241495
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2024-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aromatherapy in Providing a Semen Sample
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019341', 'term': 'Aromatherapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008517', 'term': 'Phytotherapy'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in anxiety', 'timeFrame': 'before providing a semen sample, immediately after providing a semen sample', 'description': 'The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.'}, {'measure': 'Anxiety about providing a semen sample', 'timeFrame': 'immediately after providing a semen sample', 'description': 'VAS is a 10-cm-long measurement tool. The left end of the scale reads "no anxiety " and the right end reads "very anxious". A high score on the scale indicated a high level of anxiety and a score of 0 pointed to no anxiety.'}, {'measure': 'Difficulty providing a semen sample', 'timeFrame': 'immediately after providing a semen sample', 'description': 'VAS is a 10-cm-long measurement tool. The left end of the scale reads "not difficult" and the right end reads "very difficult ". A high score on the scale indicated a high level of difficulty and a score of 0 pointed to no difficulty.'}], 'secondaryOutcomes': [{'measure': 'Semen volume', 'timeFrame': 'immediately after providing a semen sample', 'description': 'Volume of semen sample'}, {'measure': 'sperm concentration', 'timeFrame': 'immediately after providing a semen sample', 'description': 'sperm concentration of semen sample'}, {'measure': 'sperm motility percentage', 'timeFrame': 'immediately after providing a semen sample', 'description': 'sperm motility percentage of semen sample'}, {'measure': 'Total sperm count', 'timeFrame': 'immediately after providing a semen sample', 'description': 'Total sperm count of semen sample'}, {'measure': 'Satisfaction with the oil used', 'timeFrame': 'immediately after providing a semen sample', 'description': 'VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Male']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage.\n\nThe study will be carried out in two different groups. After the men are evaluated in terms of eligibility criteria for the research, the men who are eligible will be informed about the research and written informed consent will be obtained from the men who accept. The random distribution of men to the study groups will be carried out random. The following applications will be made to the groups. Aromatherapy/placebo will be applied to the individuals included in the study. During the semen sample giving process, lavender oil/coconut oil (placebo) will be applied with a diffuser.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having applied to the center where the research will be conducted with a complaint of infertility\n* Being 18 years or older\n\nExclusion Criteria:\n\n* Individuals giving up on participating in the study\n* Participant not being able to provide a semen sample\n* Being diagnosed with azoospermia-oligozoospermia'}, 'identificationModule': {'nctId': 'NCT06241495', 'briefTitle': 'Aromatherapy in Providing a Semen Sample', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'The Effect of Aromatherapy on Anxiety, Difficulty in Providing a Semen Sample and Semen Parameters', 'orgStudyIdInfo': {'id': 'İ04-205-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aromatherapy', 'interventionNames': ['Other: Aromatherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo oil will be applied to the individuals included in the study. During the semen sample giving process, coconut oil (placebo) will be applied with a diffuser.', 'armGroupLabels': ['Control Group']}, {'name': 'Aromatherapy', 'type': 'OTHER', 'description': 'Aromatherapy will be applied to the individuals included in the study. During the semen sample giving process, lavender oil will be applied with a diffuser.', 'armGroupLabels': ['Aromatherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Fertility Diagnosis, Treatment, Research and Application Center', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menekşe Nazlı AKER', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Menekşe Nazlı AKER', 'investigatorAffiliation': 'Ankara University'}}}}