CataractRELAACNCT07237061
Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery
A study testing Aromatherapy in people with Cataract and Surgery, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study looks at whether aromatherapy (scent chosen by the patient), is better than routine care, at reducing preoperative anxiety before eye surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataract, Surgery, Vitrectomy
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mental capacity for informed consent
- undergoing elective ambulatory eye surgery (including Phacoemulsification, Femtosecond laser-assisted cataract surgery (FLACS), Extracapsular cataract extraction (ECCE) and vitrectomy).
- surgery only under Monitored Anaesthesia Care (MAC)3
- surgical duration less than 45 minutes
Who cannot join
- anosmia
- allergy to aromatherapy oil
- asthma
- allergic rhinitis
- psychiatric disease
- altered mental state
Show all 10Show fewer
- lack of mental capacity
- active infection
- pregnancy
- patient or surgeon refused participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery - The RELAAC Randomised Controlled Trial
This study looks at whether aromatherapy (scent chosen by the patient), is better than routine care, at reducing preoperative anxiety before eye surgery.
- Conditions
- Cataract, Surgery, Vitrectomy, Aromatherapy, Preoperative Anxiety
- Being tested
- Aromatherapy, Placebo
- Keywords
- randomized controlled trial, placebo controlled, double blinded, two arm
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Also called lavender, geranium, lemongrass, sandalwood
patients chose their preferred aromatherapy scent to be used for at least 30 minutes
PlaceboOther
odorless dry absorbent adhesive patch
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Patients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch without any aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU). Receives: Other: Placebo |
| intervention | Experimental | Patients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch with 1 drop of their chosen aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU). Receives: Other: Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in VAS scores for preoperative anxiety
preoperative anxiety was ranked by the patient on a scale of 0-100 on a visual acuity scale (VAS) measuring 100mm, in the preoperative ambulatory ward, before and after the intervention/placebo was applied for at least 30 minutes. The change in the VAS score at these 2 timepoints was the primary outcome
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Mar 2023
- Primary completion31 Mar 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237061
- Sponsor's protocol ID
- 2020/01202
- Acronym
- RELAAC
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: local Patient Data Protection Act
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-preferred Aromatherapy Versus Placebo For Reducing Preoperative Anxiety In Patients Undergoing Eye Surgery - The RELAAC Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07237061
- Acronym / sponsor ID
- RELAAC / 2020/01202
- Conditions
- Cataract, Surgery, Vitrectomy, Aromatherapy, Preoperative Anxiety
- Keywords
- randomized controlled trial, placebo controlled, double blinded, two arm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looks at whether aromatherapy (scent chosen by the patient), is better than routine care, at reducing preoperative anxiety before eye surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: PlaceboPatients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch without any aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU). |
| intervention | Experimental | Other: AromatherapyPatients were asked to choose amongst 4 different aromatherapy scents. The study administrator then stuck an adhesive patch with 1 drop of their chosen aromatherapy oil on it, to the patient's facemask. This was worn throughout the perioperative experience from the ambulatory ward to the operating theatre and post anaesthesia care unit (PACU). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- mental capacity for informed consent
- undergoing elective ambulatory eye surgery (including Phacoemulsification, Femtosecond laser-assisted cataract surgery (FLACS), Extracapsular cataract extraction (ECCE) and vitrectomy).
- surgery only under Monitored Anaesthesia Care (MAC)3
- surgical duration less than 45 minutes
Key exclusion criteria (10 listed)
- anosmia
- allergy to aromatherapy oil
- asthma
- allergic rhinitis
- psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyAlso: lavender, geranium, lemongrass, sandalwoodpatients chose their preferred aromatherapy scent to be used for at least 30 minutes | Other | intervention |
| Placeboodorless dry absorbent adhesive patch | Other | placebo |
Primary outcome
change in VAS scores for preoperative anxiety
Time frame: 30-60 minutes
preoperative anxiety was ranked by the patient on a scale of 0-100 on a visual acuity scale (VAS) measuring 100mm, in the preoperative ambulatory ward, before and after the intervention/placebo was applied for at least 30 minutes. The change in the VAS score at these 2 timepoints was the primary outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. local Patient Data Protection Act
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Cataract and Surgery, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in VAS scores for preoperative anxiety (time frame: 30-60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.