Aromatherpy
LINK ::: https://urloso.com/2tepOX
Layout table for study information Study Type : Interventional (Clinical Trial) EstimatedEnrollment : 108 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care Official Title: Aromatherapy: An Integrative Option for Symptom Management in Cancer Care Actual Study Start Date : April 11, 2018 Actual Primary Completion Date : November 30, 2022 Estimated Study Completion Date : February 1, 2023 Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Active Comparator: Ginger aromatherapyGinger essential oil (GIN-106) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. Other: Ginger aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. Active Comparator: Orange aromatherpyOrange essential oil (ORG-114) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. Other: Orange aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. Active Comparator: Lavender aromatherapyLavender essential oil (LAV-110) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. Other: Lavender aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. Placebo Comparator: Jojoba aromatherapyJojoba oil in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. One drop of jojoba oil is on the other three aromatherapy inhalers. Jojoba oil is a \"carreir oil\" for essential oils which will be used as a comparator and placebo in this study. Other: Jojoba aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Number of participants that complete the intervention. [ Time Frame: 3 months ]Retention rate will be determined by arm. Compliance rate [ Time Frame: 3 months ]The compliance rate is the percentage of participants that report using the aromatherapy as described in protocol (i.e., at least three sniffs four times daily). Secondary Outcome Measures : Mean composite severity score [ Time Frame: 3 months ]A composite symptom severity score will be calculated for each day during each Study Cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1. Maximum composite severity score [ Time Frame: 3 months ]The maximum composite symptom severity score will be the highest severity score across the 6 days for that cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1. Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: 153554b96e
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