[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649206":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":25,"locations":32,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":65,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Singapore General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Inhalation Aromatherapy- Intervention group","EXPERIMENTAL","Participants allocated to the intervention group receive a personal nasal inhalation stick infused with a blend of Asian aromatic plant extracts formulated by a qualified aromatherapist, selected based on known anxiolytic and analgesic pharmacological properties. The final blend is determined through a scent preference evaluation conducted with five VLU patient volunteers prior to the main study. Participants inhale the stick for 5 minutes before entering the clinic room and continue using it throughout the CSWD procedure for up to 10 minutes or until the procedure is completed, inhaling at least twice in each nostril prior to the procedure. Aromatherapy works through positive olfactory effects and direct modulation of the amygdala via the olfactory nerve, potentially reducing anxiety and enhancing comfort during the procedure. Each participant is issued their own inhalation stick for personal use across all study visits to maintain hygiene and ensure consistent dosing.",[13],"Other: Inhalation Aromatherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Inhalation Placebo-Control group","PLACEBO_COMPARATOR","Participants allocated to the control group receive a personal nasal inhalation stick identical in appearance, size, and packaging to the intervention stick, containing certified organic jojoba carrier oil with no known anxiolytic properties. Jojoba oil has a barely perceptible, slightly sweet aroma and is widely used in aromatherapy blends. Participants follow an identical inhalation protocol to the intervention group, inhaling for 5 minutes before the procedure and continuing throughout CSWD for up to 10 minutes or until the procedure is completed. This ensures that any non-specific effects of the inhalation ritual, including focused breathing and expectation of benefit, are equally present in both arms, thereby isolating the specific pharmacological effect of the aromatic compounds.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Inhalation Aromatherapy","Patients are allocated to either the Inhalation Aromatherapy or Inhalation Placebo group in a 1:1 ratio via randomly permuted block randomization. The randomization sequence is generated by a non-study member using a computer-generated program. Allocation concealment is maintained through the use of sequentially numbered, opaque, sealed envelopes to prevent selection . Inhalation aromatherapy intervention an inhalation stick containing a blend of Asian aromatic plant extracts, including Basil, Elemi, and Calamansi, specifically selected for their pharmacological properties in alleviating anxiety, agitation, stress, and pain. Unlike conventional pharmacological interventions, the dose is not fixed but individually determined by the frequency of inhalation, varying based on individual pharmacokinetics and personal response to the aroma. Patients inhale at least twice, once in each nostril, beginning five minutes before the procedure and continuing throughout CSWD for up to ten minutes.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Nanthakumahrie Gunasegaran","CONTACT","97250435","+65","nanthakumahrie.gunasegaran@sgh.com.sg",[33,48],{"facility":5,"status":34,"city":35,"state":24,"zip":35,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Singapore","SG",{"type":38,"coordinates":39},"Point",[40,41],103.85007,1.28967,{"lat":41,"lon":40},[44],{"name":45,"role":28,"phone":46,"phoneExt":30,"email":47},"Singapore General Hospital Singapore General Hospital","65762590","nurshing.research@sgh.com.sg",{"facility":5,"status":34,"city":35,"state":24,"zip":35,"country":35,"countryCode":36,"cosmosGeoPoint":49,"geoPoint":51,"contacts":52},{"type":38,"coordinates":50},[40,41],{"lat":41,"lon":40},[53],{"name":45,"role":28,"phone":46,"phoneExt":30,"email":54},"nursing.research@sgh.com.sg",{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100649206","inhalation-aromatherapy-for-patients-undergoing-conservative-sharp-wound-debridement-100649206",false,"NCT07732036","Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement:","The Effectiveness and Acceptability of Inhalation Aromatherapy for Patients Undergoing Conservative Sharp Wound Debridement: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n-≥21 years old\n\n-Venous leg ulcers requiring conservative sharp wound debridement\n\nExclusion Criteria:\n\n* Known sensitivity or hypersensitivity to essential oils or any components in the Aromatherapy scent formulation\n* Allergic rhinitis, asthma, chronic lung disease or any disease that impairs the sense of smell\n* Airway hypersensitivity to fragrances, paint\u002Fgasoline fumes or turpentine\n* Using aromatherapy of any kind\n* Taking any anti-psychotic drugs\n* Incapable of providing verbal\u002Fwritten consent\n* On anti-anxiety medications","ALL","21 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this pilot clinical trial is to learn if inhalation aromatherapy works to reduce anxiety and pain in patients with venous leg ulcers undergoing conservative sharp wound debridement (CSWD). It will also learn about the feasibility of implementing this intervention in clinical practice. The main questions it aims to answer are:\n\nDoes inhalation aromatherapy reduce anxiety levels during CSWD procedures, as measured by STAI-S scores? Does inhalation aromatherapy reduce pain intensity during CSWD procedures? Is inhalation aromatherapy feasible and acceptable to implement in a clinical setting? What are the protocol adherence rates and potential areas of missing data?\n\nResearchers will compare inhalation aromatherapy using Asian essential oil extracts to standard care to see if aromatherapy works to reduce anxiety and pain during wound debridement.\n\nParticipants will:\n\nReceive either inhalation aromatherapy or standard care during their CSWD procedure Complete State-Trait Anxiety Inventory (STAI-S) questionnaires before and after the procedure Rate their pain intensity using visual analog scales during the debridement Provide feedback on treatment satisfaction and acceptability Attend clinic visits for wound debridement as part of their standard care\n\nThis pilot study hypothesizes that inhalation aromatherapy is feasible and acceptable to implement in a clinical setting and may be associated with differences in anxiety and pain intensity during CSWD, compared to standard care",[74],"Aromatherapy",[76,77,74],"Venous leg ulcers","Sharp wound debridement","2026-07-22",{"date":80,"type":81},"2026-07-28","ACTUAL",{"date":83,"type":81},"2026-06-05",{"date":85,"type":68},"2028-03-30",{"name":5,"class":6},2]