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| Name | Class |
|---|---|
| Queen Elizabeth Hospital, Hong Kong | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatherapy patches | Experimental | Standard Care + Use of Aromatherapy Patches |
|
| Placebo patches | Placebo Comparator | Standard Care + Use of Placebo Patches |
|
| Prescribed antiemetic treatment | Active Comparator | As standard care alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy patches | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Nausea and Vomiting | as measured by Rhodes Index of Nausea, Vomiting, and Retching, which consists of 8-item 4-point Likert-scales for nausea, vomiting, and retching symptoms with a total score ranging from 0 to 32 for each time point. The higher scores indicate the higher severity of nausea, vomiting, and retching experienced by the patient. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Use of patient satisfaction survey which consists of 2-item 5-point Likert scales to address the extent to which intervention could be effective in discomfort relief and control perceived by patients. The total score of the survey ranged from 2 to 10; the higher the score the more likely patients showed agreement on treatment effectiveness in discomfort relief and control. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Choi Wan CHAN, APN (NURSING) | Contact | 852-2339 | 6266 | cw.chan1@ha.org.hk |
| Victor CHEUNG, EOII(MDSSC) | Contact | 852-3506 | 8773 | ckl414@ha.org.hk |
| Name | Affiliation | Role |
|---|---|---|
| Choi Wan CHAN, APN (NURSING) | Hong Kong Buddhist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Buddhist Hospital | Recruiting | Wong Tai Sin | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22593941 | Background | 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/ | |
| 16389016 | Background | 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. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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Paralleled Randomized Controlled Trial
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After completion of written informed consent, participants would be randomly assigned to one of three groups (Intervention, Placebo, Control) by a designated clerical staff according to a blocked randomization list. Outcome assessors were independent, not knowing information regarding condition or grouping of participants.
|
| Placebo Patches | Other | 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. |
|
| Control (Standard treatment) | Drug | Prescribed antiemetic treatment |
|
| 16089309 | Background | 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. |
| 29743918 | Background | 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. |
| 32516043 | Background | 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. |
| 33288118 | Background | 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. |
| 35202019 | Background | 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. |
| 33408475 | Background | 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. |
| 34905993 | Background | Marsh E, Millette D, Wolfe A. Complementary Intervention in Postoperative Care: Aromatherapy's Role in Decreasing Postoperative Nausea and Vomiting. J Holist Nurs. 2022 Dec;40(4):351-358. doi: 10.1177/08980101211065555. Epub 2021 Dec 15. |
| 31998020 | Background | Amirshahi M, Behnamfar N, Badakhsh M, Rafiemanesh H, Keikhaie KR, Sheyback M, Sari M. Prevalence of postoperative nausea and vomiting: A systematic review and meta-analysis. Saudi J Anaesth. 2020 Jan-Mar;14(1):48-56. doi: 10.4103/sja.SJA_401_19. Epub 2020 Jan 6. |
| 10382187 | Background | Rhodes VA, McDaniel RW. The Index of Nausea, Vomiting, and Retching: a new format of the lndex of Nausea and Vomiting. Oncol Nurs Forum. 1999 Jun;26(5):889-94. |
| 33443859 | Background | Singh JR, Rand EB, Erosa SC, Cho RS, Sein M. Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures: A Randomized Trial. Am J Phys Med Rehabil. 2021 Oct 1;100(10):978-982. doi: 10.1097/PHM.0000000000001690. |
| 28395396 | Background | Trambert R, Kowalski MO, Wu B, Mehta N, Friedman P. A Randomized Controlled Trial Provides Evidence to Support Aromatherapy to Minimize Anxiety in Women Undergoing Breast Biopsy. Worldviews Evid Based Nurs. 2017 Oct;14(5):394-402. doi: 10.1111/wvn.12229. Epub 2017 Apr 10. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |