A Randomized Control Trial on the Efficacy of Aromatherapy in Reducing Postoperative Nausea and Vomiting in Total Joint Replacement Patients
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hong Kong Buddhist Hospital
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Postoperative Nausea and Vomiting
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Aromatherapy patches
Standard Care + Use of Aromatherapy Patches
Intervention: Aromatherapy patches (Other)
Placebo patches
Standard Care + Use of Placebo Patches
Intervention: Placebo Patches (Other)
Prescribed antiemetic treatment
As standard care alone
Intervention: Control (Standard treatment) (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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).)
Investigators
Choi Wan Chan
Advanced Practice Nurse, Principal Investigator
Hong Kong Buddhist Hospital