Aromatherapy in Reducing PONV for Total Joint Replacement Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHong Kong Buddhist Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 or above
Patients scheduled for total joint replacement surgery at the HKBH
Disqualifiers
Cognitive impairments
Allergy to lavender, orange, ginger, or sandalwood
Allergy to micro-pore tape
Allergy to opioid medication
Trial design
Design model
Parallel
Treatments tested in this trial
Aromatherapy patches
Other interventionApplying 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.
Placebo Patches
Other interventionOn 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)
DrugPrescribed antiemetic treatment
Treatment groups
159 Participants
are divided into 3 treatment groupsGroup A: Aromatherapy patchesExperimental treatment 1 intervention
Group B: Placebo patchesPlacebo comparator 1 intervention
Group C: Prescribed antiemetic treatmentActive comparator 1 intervention
Trial outcomes
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.
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).Secondary outcomes
1
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.
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).Sponsors and contacts
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Hong Kong Buddhist Hospital
Lead sponsor
Queen Elizabeth Hospital, Hong Kong
Collaborator
Source ClinicalTrials.gov