Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-29 @ 5:51 AM
Study NCT ID:
NCT07086495
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Aromatherapy After Aerobic Exercise"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate Recovery', 'timeFrame': 'Baseline, immediately post-exercise, and at 5 and 15 minutes after recovery', 'description': 'Heart rate was measured using a fingertip pulse oximeter. Participants remained seated and still during the measurements to ensure accuracy. The device provided real-time heart rate readings, recorded manually by the researcher.'}, {'measure': 'Systolic and Diastolic Blood Pressure', 'timeFrame': 'Baseline, immediately post-exercise, and at 5 and 15 minutes after recovery', 'description': 'Blood pressure was measured with a calibrated manual sphygmomanometer and a standard stethoscope using the auscultatory method. All measurements were taken from the left arm, with the participant in a seated position, after at least one minute of rest.'}], 'secondaryOutcomes': [{'measure': 'Oxygen Saturation (SpO₂)', 'timeFrame': 'Baseline, immediately post-exercise, and at 5 and 15 minutes after recovery', 'description': 'Oxygen saturation was assessed using a non-invasive fingertip pulse oximeter. The sensor was placed on the index finger of the dominant hand, and values were recorded once a stable reading was obtained.'}, {'measure': 'Rating of Perceived Exertion', 'timeFrame': 'Immediately post-exercise and after 15 minutes of recovery', 'description': 'Participants were asked to rate their level of exertion using the Borg 6-20 scale. The scale was visually presented, and participants pointed to the value that best represented their perceived effort. This method is validated and widely used in exercise science.'}, {'measure': 'Fatigue Severity Score', 'timeFrame': 'Before exercise and after 15 minutes of recovery', 'description': 'The FSS questionnaire was administered in printed form. Participants completed the 9-item scale independently in a quiet environment. Each item was scored on a 7-point Likert scale, and the total score was calculated by averaging all responses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aromatherapy', 'Post-exercise recovery', 'Complementary therapy', 'Athletic recovery'], 'conditions': ['Sports Recovery', 'Sports Performance']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of aromatherapy using lavender oil on recovery speed and cardiovascular parameters in healthy athletes following aerobic exercise. Participants will perform aerobic exercise using the Bruce treadmill protocol and will be randomly assigned to either an aromatherapy group (inhaling lavender essential oil) or a control group (no aromatherapy). Heart rate, blood pressure, oxygen saturation, perceived exertion, and fatigue levels will be measured before and after exercise. The study seeks to determine whether aromatherapy contributes to faster physiological recovery and reduced fatigue following exercise.', 'detailedDescription': 'Aromatherapy has gained popularity as a complementary approach in sports science, with claims of improving relaxation, reducing fatigue, and enhancing recovery. Lavender essential oil, in particular, has been associated with cardiovascular modulation and reduced perception of exertion. However, its efficacy in post-exercise recovery among athletes remains under-investigated.\n\nThis randomized controlled trial will evaluate the physiological and perceptual effects of lavender aromatherapy in athletes following aerobic exertion. Participants aged 15-35 with at least 6 months of regular sports participation will be included. The intervention group will receive inhalation-based lavender oil aromatherapy for 5 minutes after completing the Bruce treadmill protocol, while the control group will rest without aromatherapy.\n\nPrimary and secondary outcomes include heart rate recovery, blood pressure, oxygen saturation (SpO₂), Borg RPE score, and fatigue severity. Data will be collected at baseline, immediately after exercise, and at 5-minute intervals during recovery. The findings are expected to provide insights into the use of non-pharmacological recovery strategies in athletic populations.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged between 12 and 14 years\n\nActively engaged in organized sports training (minimum 2 times per week)\n\nMedically cleared to participate in moderate to vigorous physical activity\n\nNo known cardiovascular, respiratory, neurological, or metabolic conditions\n\nProvided informed assent and obtained written parental/guardian consent\n\nExclusion Criteria:\n\nKnown allergy to lavender or any component of aromatherapy oils\n\nUse of medications that may alter cardiovascular responses (e.g., beta-blockers)\n\nHistory of cardiac disease, hypertension, or arrhythmia\n\nAcute or recent musculoskeletal injury (within the last 3 months)\n\nAcute upper respiratory tract infection during the assessment week\n\nInability to complete treadmill exercise testing or follow instructions'}, 'identificationModule': {'nctId': 'NCT07086495', 'briefTitle': 'Effects of Aromatherapy After Aerobic Exercise"', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'The Effect of Aromatherapy Application on Recovery Speed and Cardiovascular Parameters After Aerobic Exercise in Athletes', 'orgStudyIdInfo': {'id': 'BvuNES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aromatherapy Group', 'description': 'Participants in this group performed aerobic exercise using the Bruce treadmill protocol. After completing the exercise, they were taken to a separate room where a diffuser had been running for 15 minutes, containing 3 drops of lavender essential oil in 100 ml of water. They inhaled the aromatherapy during a 15-minute recovery period while cardiovascular parameters were monitored.', 'interventionNames': ['Other: Aromatherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants in this group performed aerobic exercise using the Bruce treadmill protocol. After exercise, they were taken to a separate room where a diffuser had been operating for 15 minutes with only 100 ml of plain water and no essential oils. They rested in this environment for 15 minutes, during which their cardiovascular parameters were monitored. This arm aimed to control for the effect of the diffuser itself without the therapeutic component of lavender oil.', 'interventionNames': ['Other: Placebo Diffuser (No Essential Oil)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this group performed aerobic exercise using the Bruce treadmill protocol. After the exercise, they rested in a standard environment without exposure to any diffuser or aromatherapy. Their cardiovascular parameters were monitored during a 15-minute recovery period, serving as the baseline comparison for evaluating the effects of aromatherapy and placebo.'}], 'interventions': [{'name': 'Aromatherapy', 'type': 'OTHER', 'description': 'Participants inhaled lavender essential oil (3 drops in 100 ml water) via diffuser during a 15-minute post-exercise recovery period following the Bruce treadmill protocol.', 'armGroupLabels': ['Aromatherapy Group']}, {'name': 'Placebo Diffuser (No Essential Oil)', 'type': 'OTHER', 'description': 'Participants were exposed to plain water vapor (100 ml of water without essential oil) via diffuser for 15 minutes during post-exercise recovery.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to ethical considerations related to the age group of participants (12-14 years), the sensitivity of health-related information collected, and the limited scope of the study. The study involves minors, and although parental consent and participant assent were obtained, data sharing beyond the primary research team was not included in the consent process. Therefore, data will remain confidential and used solely for the purposes outlined in the approved study protocol.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}