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| ID | Type | Description | Link |
|---|---|---|---|
| 2024AMII-Aug03 | Other Grant/Funding Number | SINGHEALTH DUKE-NUS ACADEMIC MEDICINE INNOVATION INSTITUTE (AMII) NURSING INNOVATION GRANT 2024 |
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| Name | Class |
|---|---|
| National Cancer Centre, Singapore | OTHER |
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The goal of this clinical trial is to evaluate whether aromatherapy inhaler sticks can reduce nausea and vomiting in patients receiving chemotherapy as part of their stem cell transplant treatment. The main questions it aims to answer are:
Researchers will compare patients using aromatherapy inhaler sticks with essential oils to patients using inhaler sticks with only jojoba oil (placebo) to see if the essential oils provide additional benefits for reducing nausea and vomiting.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Participants in the control group will receive the placebo intervention in addition to standard care. Participants will be provided with an identical aromatherapy inhaler stick infused solely with jojoba oil. Jojoba oil, primarily used as a carrier oil for dilution, has little to- no scent and no known therapeutic or anxiolytic effects when inhaled. This ensures that any potential benefits observed in the intervention group can be attributed to the active essential oil blends rather than the inhalation process itself. |
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| Intervention group | Active Comparator | Participants in the intervention group will receive inhalation therapy via an aromatherapy inhaler stick*, on top of standard care. Participants will be instructed to use the inhaler stick every four hours when they are awake, and whenever they feel nauseous, by holding the inhaler stick a finger's length away from their nostrils and inhaling through one nostril at a time. Each administration should not last more than 5 minutes. Participants will commence using the inhaler stick on the day of chemotherapy, until five days after the completion of chemotherapy (a total of six days). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy inhaler | Other | Participants in the intervention group will receive inhalation therapy via an aromatherapy inhaler stick*, on top of standard care. Participants will be instructed to use the inhaler stick every four hours when they are awake, and whenever they feel nauseous, by holding the inhaler stick a finger's length away from their nostrils and inhaling through one nostril at a time. Each inhaler administration should not last more than 5 minutes. Participants will commence using the inhaler stick on the day of chemotherapy, until five days after the completion of chemotherapy (total of six days). Given the subjective nature of scents, participants in the intervention group will be given a choice between two therapeutic aroma blends - N1 and N2 - before commencing the study. This approach aims to minimize the risk of negative associations with a particular scent and enhance participant adherence to the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Percentage of eligible patients who consent to join the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT) | From commencement of study (Day 1) to the end of treatment (Day 6) |
| Retention Rate | Percentage of participants who complete the study will be measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT) | From commencement of study (Day 1) to the end of treatment (Day 6) |
| Adherence rate | Percentage of participants in the intervention group who use the inhaler stick as instructed measured to evaluate the feasibility of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT) | From commencement of study (Day 1) to the end of treatment (Day 6) |
| Patient-reported satisfaction | Measured through Likert-scale items at the end of the study to evaluate the acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing hematopoietic stem cell transplant (HSCT). The Feasibility of intervention Likert-scale and the Acceptability of intervention Liker-scale will be used. The Likert-scale consist of a rating of 1- 5 where 1 is strongly disagree and 5 is strongly agree and to be rated by participants. | From commencement of study (Day 1) to the end of treatment (Day 6) |
| Perceptions and Overall Experience | Qualitative insights from semi-structured interviews on ease of use, perceived helpfulness and overall experience to evaluate acceptability of using inhalation aromatherapy to reduce chemotherapy-induced nausea and vomiting (CINV) for patients undergoing haematopoietic stem cell transplant (HSCT) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Nausea | Patient-reported nausea severity measured daily using a Visual Analog Scale (VAS, 0 = no nausea, 10 = worst possible nausea). | From commencement of study (Day 1) to the end of treatment (Day 6) |
| Frequency of Vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Tay, Bachelor of Nursing | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | 169608 | Singapore |
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| Aromatherapy inhaler (placebo) | Other | Participants in the control group will receive the placebo intervention in addition to standard care. They will be provided with an identical aromatherapy inhaler stick infused solely with jojoba oil. Jojoba oil, primarily used as a carrier oil for dilution, has littleto- no scent and no known therapeutic or anxiolytic effects when inhaled. |
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| From commencement of study (Day 1) to the end of treatment (Day 6) |
Number of vomiting episodes recorded in patient journals and verified against electronic medical records
| From commencement of study (Day 1) to the end of treatment (Day 6) |
| Use of Rescue Anti-Emetics | Frequency and dosage of rescue anti-emetic medication administered, retrieved from electronic medical records | From commencement of study (Day 1) to the end of treatment (Day 6) |
| Oral Intake | Daily oral intake as documented in medical records as an indicator of nausea levels | From commencement of study (Day 1) to end of treatment (Day 6) |
| Grading of Chemotherapy-Induced Nausea and Vomiting (CINV) | Grading of CINV severity using the Common Terminology Criteria for Adverse Events (CTCAE v5.0) on a 0-4 scale, where higher scores indicate more severe symptoms | From commencement of study (Day 1) to end of treatment (Day 6) |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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