Lavender Sandalwood Aromatherapy Study

Официальное название

Does Aromatherapy Improve Mood and Reduce Pain in Women After Scheduled Cesarean Procedures?

Обзор

The purpose of this randomized controlled study is to explore whether lavender sandalwood aromatherapy can support comfort, mood, pain relief, and overall satisfaction for participants recovering from a scheduled cesarean section without complications. The main questions this study aims to answer are: * How does lavender sandalwood aromatherapy affect participants' mood during postpartum recovery after a cesarean section? * Does lavender sandalwood aromatherapy help reduce pain during recovery? * Does lavender sandalwood aromatherapy improve participants' overall satisfaction with their recovery experience? Researchers will compare participants who receive lavender-sandalwood aromatherapy with those who do not to determine whether it improves mood, reduces pain, and enhances patient satisfaction. Participants will be asked to: * Wear aromatherapy tabs on their gown for 24 hours. * Have the aromatherapy tabs applied 24 hours after the cesarean section and removed 48 hours after the cesarean section. * Complete surveys at 24 hours and 48 hours after the cesarean section. This will apply to both the control and intervention groups.

Подробное описание

Aromatherapy represents a holistic, patient-centered approach designed to enhance comfort, relaxation, and sleep for individuals receiving medical care. This method is both cost-effective and associated with minimal side effects, making it an appealing option as a complementary therapy. For centuries, essential oils have been incorporated into care routines to help relieve a variety of symptoms, including pain, anxiety, stress, and insomnia. Their use is especially prominent during significant life events such as pregnancy, labor, and the postpartum period, where they support emotional and physical well-being.

This randomized controlled trial has been designed to assess the therapeutic effects of Lavender Sandalwood Elequil Aromatabs in women scheduled for planned cesarean sections. In this study, participants in the experimental group will receive self-adhesive aromatherapy tabs containing a blend of lavender and sandalwood essential oils. These tabs are conveniently placed on hospital gowns and are intended to deliver continuous aromatic benefits for up to 24 hours following surgery, in addition to the standard post-operative care provided. Participants in the control group, on the other hand, will receive only the standard care without aromatherapy exposure.

The primary objectives of this study are to evaluate changes in emotional well-being, pain perception, and overall patient satisfaction among cesarean-section patients. Emotional states will be measured using the Positive and Negative Affect Schedule (PANAS), which captures both positive and negative mood dimensions. Pain levels will be assessed with the Defense Veterans Pain Rating Scale (DVPRS), a validated tool for quantifying pain intensity. Additionally, the Net Promoter Score (NPS) will be used to gauge patient satisfaction with their care experience. Collectively, these measures will offer comprehensive insights into how aromatherapy may contribute to improved recovery and holistic well-being during the post-surgical period.

Вмешательства

• Другое Lavender-sandalwood aromatherapy tabs
  The intervention used in this study consists of aromatherapy tabs infused with lavender and sandalwood essential oils. These aromatabs are administered to participants following their cesarean section procedures to evaluate their effectiveness in managing postoperative pain. The choice of lavender and sandalwood is based on their widely recognized calming and analgesic properties, with the goal of providing non-pharmacological support for pain relief. Participants in the experimental group will

Первичные конечные точки

• PANAS survey to measure mood [Срок оценки: The period begins when you enroll and ends when you are discharged, and usually covers a timeframe of three to six days.]

Вторичные конечные точки (1)

• DVPRS to Measure Pain and Patient Satisfaction [Срок оценки: The period begins when the participants enroll and ends when they are discharged, and usually covers a timeframe of three to six days.]

Критерии участия

Критерии включения

• To be eligible for participation in the study, individuals must have a cesarean section scheduled in advance and must be admitted to the postpartum unit following their delivery. Additionally, potential participants are required to undergo pre-admission testing. Patients who meet all these conditions-having a planned cesarean procedure, admission to the postpartum unit after delivery, and completion of pre-admission testing within the specified days-will be considered for enrollment in the study.

Критерии исключения

• Individuals will be excluded from participation in the study if they meet any of the following criteria: First, patients who have an allergy or hypersensitivity to essential oils, including but not limited to lavender or sandalwood, will not be eligible due to the potential risk of adverse reactions associated with exposure to these substances. Second, participants whose newborns require admission to the Neonatal Intensive Care Unit (NICU) following delivery will be excluded, as this circumstance may impact maternal mood and recovery, potentially confounding the study outcomes. Third, patients who are admitted to the labor and delivery unit before their scheduled cesarean section procedure will not be considered for enrollment, since the study is specifically designed for individuals undergoing planned cesarean deliveries and admitted directly to the postpartum unit.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Memorial Hermann Memorial City Medical Center — Houston

Публикации

• Hedigan F, Sheridan H, Sasse A. Benefit of inhalation aromatherapy as a complementary treatment for stress and anxiety in a clinical setting - A systematic review. Complement Ther Clin Pract. 2023 Aug;52:101750. doi: 10.1016/j.ctcp.2023.101750. Epub 2023 Apr 5. PMID 37031643
• Lin PH, Lin YP, Chen KL, Yang SY, Shih YH, Wang PY. Effect of aromatherapy on autonomic nervous system regulation with treadmill exercise-induced stress among adolescents. PLoS One. 2021 Apr 13;16(4):e0249795. doi: 10.1371/journal.pone.0249795. eCollection 2021. PMID 33848307
• Vora LK, Gholap AD, Hatvate NT, Naren P, Khan S, Chavda VP, Balar PC, Gandhi J, Khatri DK. Essential oils for clinical aromatherapy: A comprehensive review. J Ethnopharmacol. 2024 Aug 10;330:118180. doi: 10.1016/j.jep.2024.118180. Epub 2024 Apr 16. PMID 38614262
• Tabatabaeichehr M, Mortazavi H. The Effectiveness of Aromatherapy in the Management of Labor Pain and Anxiety: A Systematic Review. Ethiop J Health Sci. 2020 May;30(3):449-458. doi: 10.4314/ejhs.v30i3.16. PMID 32874088
• Hadi N, Hanid AA. Lavender essence for post-cesarean pain. Pak J Biol Sci. 2011 Jun 1;14(11):664-7. doi: 10.3923/pjbs.2011.664.667. PMID 22235509
• Caballero-Gallardo K, Quintero-Rincon P, Olivero-Verbel J. Aromatherapy and Essential Oils: Holistic Strategies in Complementary and Alternative Medicine for Integral Wellbeing. Plants (Basel). 2025 Jan 29;14(3):400. doi: 10.3390/plants14030400. PMID 39942962
• Blackburn LM, Burns K, DiGiannantoni E, Meade K, O'Leary C, Stiles R. Pain Assessment: Use of the Defense and Veterans Pain Rating Scale in Patients With Cancer. Clin J Oncol Nurs. 2018 Dec 1;22(6):643-648. doi: 10.1188/18.CJON.643-648. PMID 30451995
• Bertone AC, Dekker RL. Aromatherapy in Obstetrics: A Critical Review of the Literature. Clin Obstet Gynecol. 2021 Sep 1;64(3):572-588. doi: 10.1097/GRF.0000000000000622. PMID 33927109

Идентификаторы

NCT: NCT07737392 · HSC-MH-25-0731

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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