NCT07281885

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

December 2, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

AromatherapyPONV

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

  • Patient Satisfaction

    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).

Study Arms (3)

Aromatherapy patches

EXPERIMENTAL

Standard Care + Use of Aromatherapy Patches

Other: Aromatherapy patches

Placebo patches

PLACEBO COMPARATOR

Standard Care + Use of Placebo Patches

Other: Placebo Patches

Prescribed antiemetic treatment

ACTIVE COMPARATOR

As standard care alone

Drug: Control (Standard treatment)

Interventions

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.

Placebo 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.

Also known as: Lavender-Sandalwood patch, Orange-Ginger patch
Aromatherapy patches

Prescribed antiemetic treatment

Prescribed antiemetic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Buddhist Hospital

Wong Tai Sin, Hong Kong, Hong Kong

RECRUITING

Related Publications (13)

  • 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: 22593941BACKGROUND
  • 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: 16389016BACKGROUND
  • 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: 16089309BACKGROUND
  • 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: 29743918BACKGROUND
  • 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: 32516043BACKGROUND
  • 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: 33288118BACKGROUND
  • 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: 35202019BACKGROUND
  • 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: 33408475BACKGROUND
  • 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.

    PMID: 34905993BACKGROUND
  • 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.

    PMID: 31998020BACKGROUND
  • 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.

    PMID: 10382187BACKGROUND
  • 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.

    PMID: 33443859BACKGROUND
  • 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.

    PMID: 28395396BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Choi Wan CHAN, APN (NURSING)

    Hong Kong Buddhist Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Choi Wan CHAN, APN (NURSING)

CONTACT

Victor CHEUNG, EOII(MDSSC)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Paralleled Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advanced Practice Nurse, Principal Investigator

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations