"The Effect of Lavender Aromatherapy on Dental Anxiety"
"The Effect of Lavender Aromatherapy on Dental Anxiety-A Randomized Control Trial"
ABSTRACT
Background:
Dental anxiety is addressed as a common issue in adults, often delaying necessary dental treatments and impacting overall oral health. Conventional anxiety management methods may not be preferred due to certain limitations, therefore prompting interest in complementary therapies. The most promising therapy is aromatherapy. Aromatherapy uses essential oils for relaxation to reduce stress. This approach is non-invasive and accessible, making it a promising option for reducing dental anxiety. This study will examine the effect of aromatherapy in adults undergoing dental treatment, highlighting holistic strategies in dental care.
Aim of the study:
This study aimed to determine the effect of aromatherapy on dental anxiety among dental patients.
Methodology:
The study will be a randomized control trial, with 68 participants divided into two groups, Experimental (aromatherapy) and Control, randomizing through Sequentially Numbered, Opaque, and Sealed Envelopes (SNOSE). This trial will be conducted at dental OPD, Dr. Ishrat ul Ebad Khan Institute of Oral Health Sciences. The patients of both gender aged 20-45 years, requiring any dental procedure and providing an informed consent form will be part of the study. Patients with colds, asthma, or other respiratory diseases, acoustic problems, allergic to lavender oils used in the study and mental and physical disabilities will be excluded. It will be a single-blinded study where the examiner is unaware of group allocation. Questionnaires will be used to evaluate patient anxiety levels before the intervention and after dental procedure. Intervention (Aromatherapy) will be administered via nebulizer for 15 minutes. The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes. Physiological data will be collected to measure stress response, including systolic and diastolic blood pressure, pulse rate, and oxygen saturation, using a digital sphygmomanometer and pulse oximeter at the start of the intervention (baseline) and at the end of the dental procedure.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This randomized control trial will be conducted at the Dow University of Health Sciences-Dr. Ishratul Ebad Khan Institute of Oral Health Sciences. It aims to assess the effect of aromatherapy on dental anxiety in dental patients, during dental procedures The study will involve 68 patients aged 20-45, with equal numbers assigned to two groups: Experimental group receiving aromatherapy and control receiving placebo intervention. Participants will be selected using a non-probability convenience sampling technique, with randomization achieved through Sequentially Numbered, Opaque, and Sealed Envelopes (SNOSE). Inclusion criteria include consenting patients of both gender aged 20-45 years and seeking for one of the following dental procedures: root canal treatment, scaling and polishing or tooth extraction for the very first time while patients with respiratory diseases, allergies to lavender oils, or mental and physical disabilities will be excluded. Patient who may refuse to continue the intervention and are non-cooperative will be excluded.
Data collection will include administration of anxiety questionnaires before the intervention and after the procedure. Intervention (Aromatherapy) will be administered via nebulizer for 15 minutes. The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes Physiological data such as blood pressure, pulse rate, and oxygen saturation will also be collected to assess the body's stress response.
The sample size was calculated using Open Epi software, with a margin of error of 5% and a significance level of 0.05. Descriptive statistics will summarize the data, while inferential statistics, including paired t-tests and RM will be used for within-group and between-group comparisons, respectively. SPSS version 21 will be used for data analysis, with a significance level set at ≤ 0.05.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Sadaf Arshi, MSc. in Community Dentistry
- Номер телефона: 02138771111
- Электронная почта: sadaf.arshi@duhs.edu.pk
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Patients who will give consent to the study.
- Patients aged 20-45 years undergoing dental treatment for the first time.
- Both gender.
- Patient seeking any one of the following dental procedures: root canal treatment, scaling and polishing or tooth extraction.
Exclusion Criteria
- Patients with colds, asthma, and any other respiratory diseases.
- Patients with acoustic problems.
- Patients who are allergic Lavender oils that have been used in this study.
- Patients with mental and physical disabilities.
- Patient who may refuse to continue the intervention will be excluded.
- Non cooperative patients.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental: Aromatherapy will be administered.
Lavender Aromatherapy will administrated to Experimental group
|
Lavender Aromatherapy will administrated to Experimental group
|
|
Плацебо Компаратор: Group 2: (Control): Placebo intervention
|
The control group will receive placebo intervention via nebulizer filled with normal saline for 15 minutes to remain calm and anxiety free.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Dental anxiety
Временное ограничение: one hour
|
Dental Anxiety status measured by Modified Dental anxiety scale.
The minimum and maximum values recorded by Modified dental anxiety scale will be < 10 and >19 respectively and the higher scores means high dental anxiety which is worse outcome
|
one hour
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Physiological Parameters
Временное ограничение: One hour
|
Both Systolic and Diastolic Blood pressure measured in mm of Hg. . |
One hour
|
|
Physiological Parameter
Временное ограничение: one hour
|
Pulse rate measured as beats per minutes (BPM)
|
one hour
|
|
Physiological Parameter
Временное ограничение: one hour
|
Oxygen saturation measured in %
|
one hour
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Karan NB. Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Physiol Behav. 2019 Nov 1;211:112676. doi: 10.1016/j.physbeh.2019.112676. Epub 2019 Sep 7.
- Kritsidima M, Newton T, Asimakopoulou K. The effects of lavender scent on dental patient anxiety levels: a cluster randomised-controlled trial. Community Dent Oral Epidemiol. 2010 Feb;38(1):83-7. doi: 10.1111/j.1600-0528.2009.00511.x. Epub 2009 Nov 23.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- DUHS/IRB/EXTENSION/2026/362
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .