- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07281885
Aromatherapy in Reducing PONV for Total Joint Replacement Patients (RCT PONV)
January 5, 2026 updated by: Choi Wan Chan, Hong Kong Buddhist Hospital
A Randomized Control Trial on the Efficacy of Aromatherapy in Reducing Postoperative Nausea and Vomiting in Total Joint Replacement Patients
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Victor CHEUNG, EOII(MDSSC)
- Phone Number: 8773 852-3506
- Email: ckl414@ha.org.hk
Study Contact Backup
- Name: Choi Wan CHAN, APN (NURSING)
- Phone Number: 6266 852-2339
- Email: cw.chan1@ha.org.hk
Study Locations
-
-
Hong Kong
-
Wong Tai Sin, Hong Kong, Hong Kong
- Recruiting
- Hong Kong Buddhist Hospital
-
Contact:
- Choi Wan CHAN, APN (NURSING)
- Phone Number: 6266 852-2339
- Email: cw.chan1@ha.org.hk
-
Sub-Investigator:
- Ka Wai Fiona Mak, WM (NURSING)
-
Sub-Investigator:
- Claudia Fuk Chi Cheng, RN (NURSING)
-
Sub-Investigator:
- Victor Cheng, EOII(MDSSC)
-
Sub-Investigator:
- Yuk Chun Lai, RN (NURSING)
-
Sub-Investigator:
- Yat Hung Lee, RN (NURSING)
-
Sub-Investigator:
- Kwan Yi Lew, RN (NURSING)
-
Sub-Investigator:
- Ka Wun Sit, APN (NURSING)
-
Sub-Investigator:
- Wing Sze Tse, RN (NURSING)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 18 or above
- Patients scheduled for total joint replacement surgery at the HKBH
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aromatherapy patches
Standard Care + Use of 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.
Other Names:
|
|
Placebo Comparator: Placebo patches
Standard Care + Use of 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.
|
|
Active Comparator: Prescribed antiemetic treatment
As standard care alone
|
Prescribed antiemetic treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Nausea and Vomiting
Time Frame: 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).
|
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).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction
Time Frame: 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).
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Choi Wan CHAN, APN (NURSING), Hong Kong Buddhist Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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/
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
December 2, 2025
First Submitted That Met QC Criteria
December 2, 2025
First Posted (Estimated)
December 15, 2025
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB-2025-242-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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