Aromatherapy in Reducing PONV for Total Joint Replacement Patients

Официальное название

A Randomized Control Trial on the Efficacy of Aromatherapy in Reducing Postoperative Nausea and Vomiting in Total Joint Replacement Patients

Обзор

This study investigates the effectiveness of aromatherapy in reducing postoperative nausea and vomiting (PONV) among patients undergoing total joint replacement surgery, as these complications can lead to patient discomfort and prolonged recovery. It is designed as a randomized controlled trial involving 159 participants, who will be divided into three groups: an intervention group receiving aromatherapy patches (lavender-sandalwood or orange-ginger) plus standard care, a placebo group with a placebo patch plus standard care, and a control group receiving standard care alone. PONV will be measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) at baseline, 30 minutes after the intervention, and every 12 hours post-surgery. Additionally, patient satisfaction will be assessed through a 5-point Likert scale survey. The primary outcome of the study is the evaluation of RINVR scores, while the secondary outcome focuses on patient satisfaction levels. Data will be statistically analyzed using two-way ANOVA for repeated measures, with a significance level defined as p \< 0.05. The study aims to determine the viability of aromatherapy as a complementary treatment for PONV, potentially improving postoperative care, enhancing patient satisfaction, and offering a cost-effective alternative to conventional anti emetic treatments if proven effective.

Вмешательства

• Другое Aromatherapy patches
  Applying aromatherapy patch served as intervention part in addition to standard care. Aromatherapy patch will be attached to the inner side of of the patient's top covered by a plain gauze with micro-pore tape.
• Другое Placebo Patches
  On top of standard care. Placebo patch, which looks like the aromatherapy patch but contains no element of any essential oil, will be attached to the inner side of of the patient's top covered by a plain gauze with micro-pore tape.
• Препарат Control (Standard treatment)
  Prescribed antiemetic treatment

Первичные конечные точки

• Postoperative Nausea and Vomiting [Срок оценки: Through study completion, an average of 24 hours at 4 timepoints: T0 (baseline at PACU), T1 (up to 30 minutes from applying intervention to reassessment at PACU), T2 (up to 12-hour post-intervention in ward), T3 (up to 24-hour post-intervention in ward).]

Вторичные конечные точки (1)

• Patient Satisfaction [Срок оценки: Through study completion, an average of 24 hours at 4 timepoints: T0 (baseline at PACU), T1 (up to 30 minutes from applying intervention to reassessment at PACU), T2 (up to 12-hour post-intervention in ward), T3 (up to 24-hour post-intervention in ward).]

Критерии участия

Критерии включения

• Adults aged 18 or above
• Patients scheduled for total joint replacement surgery at the HKBH

Критерии исключения

• Cognitive impairments
• Allergy to lavender, orange, ginger, or sandalwood
• Allergy to micro-pore tape
• Allergy to opioid medication
• Undergoing other therapeutic treatment for PONV control, except prescribed medications

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

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Hong Kong Buddhist Hospital — Wong Tai Sin

Публикации

• Bode AM, Dong Z. The Amazing and Mighty Ginger. In: Benzie IFF, Wachtel-Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd edition. Boca Raton (FL): CRC Press/Taylor & Francis; 2011. Chapter 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK92775/ PMID 22593941
• Chaiyakunapruk N, Kitikannakorn N, Nathisuwan S, Leeprakobboon K, Leelasettagool C. The efficacy of ginger for the prevention of postoperative nausea and vomiting: a meta-analysis. Am J Obstet Gynecol. 2006 Jan;194(1):95-9. doi: 10.1016/j.ajog.2005.06.046. PMID 16389016
• Chou FH, Avant KC, Kuo SH, Cheng HF. Assessing the psychometric and language equivalency of the Chinese versions of the Index of Nausea, Vomiting and Retching, and the Prenatal Self-Evaluation Questionnaire. Kaohsiung J Med Sci. 2005 Jul;21(7):314-21. doi: 10.1016/S1607-551X(09)70127-5. PMID 16089309
• Cardia GFE, Silva-Filho SE, Silva EL, Uchida NS, Cavalcante HAO, Cassarotti LL, Salvadego VEC, Spironello RA, Bersani-Amado CA, Cuman RKN. Effect of Lavender (Lavandula angustifolia) Essential Oil on Acute Inflammatory Response. Evid Based Complement Alternat Med. 2018 Mar 18;2018:1413940. doi: 10.1155/2018/1413940. eCollection 2018. PMID 29743918
• Ford C, Park LJ. Assessing and managing nausea and vomiting in adults. Br J Nurs. 2020 Jun 11;29(11):602-605. doi: 10.12968/bjon.2020.29.11.602. No abstract available. PMID 32516043
• Gress K, Urits I, Viswanath O, Urman RD. Clinical and economic burden of postoperative nausea and vomiting: Analysis of existing cost data. Best Pract Res Clin Anaesthesiol. 2020 Dec;34(4):681-686. doi: 10.1016/j.bpa.2020.07.003. Epub 2020 Jul 18. PMID 33288118
• A Pilot Randomized Control Trial to Assess the Impact of Lavender on Anxiety and Comfort After Cesarean Birth and the Barriers Encountered. MCN Am J Matern Child Nurs. 2022 Mar-Apr 01;47(2):E3. doi: 10.1097/NMC.0000000000000807. No abstract available. PMID 35202019
• Jin Z, Gan TJ, Bergese SD. Prevention and Treatment of Postoperative Nausea and Vomiting (PONV): A Review of Current Recommendations and Emerging Therapies. Ther Clin Risk Manag. 2020 Dec 31;16:1305-1317. doi: 10.2147/TCRM.S256234. eCollection 2020. PMID 33408475

Идентификаторы

NCT: NCT07281885 · CIRB-2025-242-5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗