Aromatherapy as Treatment for n/v of Pregnancy
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StatusConcluído
Patrocinadores
Albany Medical College
ENSAIO CLÍNICO: NCT03609567
BioSeek: nct03609567
Palavras-chave
Resumo
A double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.
Descrição
This is a double-blinded randomized controlled trial investigating the utility of essential oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first trimester of pregnancy.
datas
| Última verificação: | 06/30/2018 |
| Enviado pela primeira vez: | 07/09/2018 |
| Inscrição estimada enviada: | 07/30/2018 |
| Postado pela primeira vez: | 07/31/2018 |
| Última atualização enviada: | 06/30/2019 |
| Última atualização postada: | 07/04/2019 |
| Data real de início do estudo: | 05/31/2017 |
| Data Estimada de Conclusão Primária: | 02/28/2019 |
| Data Estimada de Conclusão do Estudo: | 02/28/2019 |
Condição ou doença
Pregnancy Emesis
Intervenção / tratamento
Other: Aromatherapy
Other: Placebo
Fase
-
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Aromatherapy Aromatherapy using essential oils | Other: Aromatherapy Aromatherapy using essential oils |
| Placebo Comparator: Placebo Aromatherapy using odorless placebo | Other: Placebo Aromatherapy using odorless placebo oil |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | Female |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - Pregnancy at <14 weeks gestation - English-speaking - Baseline PUQE score >=6 Exclusion Criteria: - Non-compliant with prenatal care or study procedures - Hyperemesis gravidarum - Allergies to perfumes, essential oils or cosmetics - Abnormal sense of smell - Known acute or chronic GI disease - Asthma - Use of prescription anti-emetics |
Resultado
Medidas de Resultado Primário
1. Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score [First trimester of pregnancy]
PUQE score is a validated measure of nausea and vomiting in pregnancy. It is a reliable tool used to measure the severity of nausea and vomiting of pregnancy. It is a questionnaire that measures the number of times in 24 hours a patient wretches, vomits, or feels nauseous. The minimum score is 3, and the maximum is 15. Participants will have PUQE scores calculated at baseline (during enrollment in the first trimester of pregnancy, at whatever age they are at), and after one month of aromatherapy use with either essential oils or placebo, with the mean difference from baseline compared as primary outcome. The Time Frame for participation will be from enrollment until the end of the first trimester (13th week of pregnancy), which, depending on gestational age in weeks at enrollment, may be up to 8 weeks.
