Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 10, 2022
Open Peer Review Period: Apr 10, 2022 - Jun 5, 2022
Date Accepted: Jun 7, 2022
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effects of Aromatherapy on Depressive of Neurotic Smoking Patients during Smoking Cessation Treatment: Protocol for a Prospective Cohort Study
ABSTRACT
Background:
Cessation of smoking can markedly reduce the incidence of cardiovascular disease, improve health economics, and benefit society. Aromatherapy has the potential to be a novel option of adjuvant therapy for smoking cessation that may alleviate depressive symptoms. However, research on the efficacy of aromatherapy as an adjuvant therapy for smoking cessation is scarce.
Objective:
The purpose of this study was to examine the potential effects of aromatherapy on psychological states in smokers with depressive tendencies and to determine if it is reasonable to proceed to the next step.
Methods:
Methods:
This is a prospective cohort study with a single arm. Smokers with neurosis and depression will be subjected to aromatherapy during smoking cessation treatment for 12 weeks. We will evaluate changes in scores on the Self-Rating Depression Scale and Profile of Mood States from the pre-treatment screening to 4 weeks/12 weeks after the start of aromatherapy. Moreover, we will compare the group treated with aromatherapy with the group that received standard treatment in our previous randomised controlled trial as the control group in this study. Furthermore, we will compare successful smoking cessation rates after 12 weeks. In addition, we will conduct an exploratory analysis of the efficacy of aromatherapy. The target sample size is 100, which is the number of subjects expected to be enrolled in this study within two years.
Results:
This study was approved by the Kyoto Medical Center institutional review board (approval number: 19-016). Currently, we are in the process of recruitment for this study.
Conclusions:
The present study has some limitations. This is not a rigorous validation study because it compares the same subjects who received standard treatment in a previous study. Moreover, the sample size and methods of statistical analysis were not fully set with prior consideration of statistical rigor. To address these limitations, we plan to conduct a phase III trial that will reflect the exploratory findings of this study. This is the first study to evaluate the psychological effects of aromatherapy during smoking cessation program, and may help improve the quality of treatment for smoking cessation in the future. Clinical Trial: Trial registration: UMIN Clinical Trials Registry UMIN000043102; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049123
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.