[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658610":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":23,"studyPopulation":17,"armGroups":24,"interventions":41,"overallOfficials":17,"centralContacts":49,"locations":55,"responsibleParty":74,"collaborators":17,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":17,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":106,"whyStopped":17,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Basrah","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Procedural pain intensity during negative pressure wound therapy dressing change","Pain intensity experienced by participants during the negative pressure wound therapy dressing change, assessed using the Visual Analogue Scale","pre-intervention, during intervention, immediately after the intervention",[14],{"measure":15,"description":16,"timeFrame":12},"Procedural anxiety","Participant-reported anxiety associated with the negative pressure wound therapy dressing change, assessed using a validated anxiety assessment scale. Higher scores indicate greater anxiety.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":6,"observationalModel":17,"timePerspective":17,"maskingInfo":21},"RANDOMIZED","PARALLEL",{"masking":22,"maskingDescription":17,"whoMasked":17},"NONE","This randomized controlled trial will evaluate whether a personalized natural sound therapy approach provides additional benefit compared with a standardized natural sound therapy approach during negative pressure wound therapy dressing changes.\n\nNegative pressure wound therapy dressing changes can be associated with substantial procedural pain and may cause anxiety during manipulation of the wound and removal or replacement of the dressing. Natural sound therapy is a non-pharmacological intervention that may provide an auditory distraction and promote relaxation during potentially painful procedures. However, the therapeutic effect may vary according to individual preferences and responses to different types of natural sounds.\n\nIn the personalized intervention, each participant will select or identify the type of natural sound that they find most pleasant, relaxing, or comfortable from a predefined selection provided by the research team. The selected sound will then be used during the dressing-change procedure. In the standardized intervention, participants will receive a predetermined natural sound selected by the research team, regardless of individual sound preference.\n\nThe assigned intervention will be delivered using the same standardized audio equipment and under comparable environmental conditions for both groups. The timing and duration of sound exposure will be standardized according to the study protocol to ensure that the primary difference between groups is the personalization of the natural sound.\n\nBefore the procedure, participants will receive an explanation of the study procedures and will be allowed to become familiar with the audio equipment and assigned sound. During the dressing change, the research team will follow a standardized procedural protocol. Participants will be monitored throughout the procedure, and any clinically important discomfort or adverse event will be managed according to routine clinical practice.\n\nTo reduce potential bias, outcome assessment and data collection procedures will be standardized across the two intervention groups. The same assessment schedule and measurement procedures will be applied to participants regardless of their assigned intervention.\n\nThe study is designed to determine whether personalization of natural sound therapy represents a meaningful modification of a non-pharmacological intervention for managing procedural pain and anxiety during negative pressure wound therapy dressing changes. Findings may provide evidence regarding the feasibility and potential clinical value of incorporating patient preference into auditory interventions used during painful nursing procedures.",[25,31,37],{"label":26,"type":27,"description":28,"interventionNames":29},"Personalized Natural Sound Therapy","EXPERIMENTAL","Participants will receive personalized natural sound therapy during the negative pressure wound therapy dressing change. Before the procedure, each participant will select their preferred natural sound from a predefined selection. The selected sound will be played through headphones or the study audio device throughout the specified period of the dressing-change procedure.",[30],"Behavioral: Personalized Natural Sound Therapy",{"label":32,"type":33,"description":34,"interventionNames":35},"Standardized Natural Sound Therapy","ACTIVE_COMPARATOR","Participants will receive standardized natural sound therapy during the negative pressure wound therapy dressing change. All participants assigned to this group will listen to the same predetermined natural sound selected by the research team. The sound will be delivered using the same equipment and for the same duration as in the personalized intervention group.",[36],"Behavioral: Standardized Natural Sound Therapy",{"label":38,"type":39,"description":40,"interventionNames":17},"Control","NO_INTERVENTION","Participants will receive standard care during the negative pressure wound therapy dressing change without natural sound therapy. No therapeutic audio intervention will be provided. Participants will undergo the dressing change according to the usual clinical procedure and will receive the same routine care and monitoring as the intervention groups.",[42,46],{"type":43,"name":26,"description":44,"armGroupLabels":45,"otherNames":17},"BEHAVIORAL","Participants will listen to a natural sound selected according to their individual preference during the negative pressure wound therapy dressing change.",[26],{"type":43,"name":32,"description":47,"armGroupLabels":48,"otherNames":17},"Participants will listen to the same predetermined natural sound during the negative pressure wound therapy dressing change.",[32],[50],{"name":51,"role":52,"phone":53,"phoneExt":17,"email":54},"Ali M Dr. Ali Malik Tiryag, PhD","CONTACT","+9647811735332","ali.malik@uobasrah.edu.iq",[56],{"facility":57,"status":17,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"College of Nursing, University of Basrah","Basra","Basrah","61004","Iraq","IQ",{"type":64,"coordinates":65},"Point",[66,67],47.7804,30.50852,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":17,"email":73},"Sundus B Sundus Baqer Dawood, PhD","+9647707096503","sindus.dawood@uobasrah.edu.iq",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Ali Malik Tiryag","Doctor Lecturer","100658610","natural-sound-therapy-on-procedural-pain-and-anxiety-during-negative-pressure-wound-therapy-dressing-changes-100658610",false,"NCT07854717","Natural Sound Therapy on Procedural Pain and Anxiety During Negative Pressure Wound Therapy Dressing Changes","Effects of Personalized Versus Standardized Natural Sound Therapy on Procedural Pain and Anxiety During Negative Pressure Wound Therapy Dressing Changes: A Randomized Controlled Trial","NPAWTDC","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Patients receiving negative pressure wound therapy requiring a dressing change.\n* Patients who are able to communicate verbally and understand the study procedures.\n* Patients who are able to report their pain and anxiety using the study assessment tools.\n* Patients who provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients with cognitive impairment or altered level of consciousness that prevents reliable communication or outcome assessment.\n* Patients who are unable to understand the study instructions or complete the required assessments.\n* Patients receiving deep sedation or general anesthesia during the dressing change.\n* Patients with severe hearing impairment that prevents them from receiving the auditory intervention.\n* Patients with an acute medical condition requiring immediate intervention that would interfere with the study procedure or assessments.\n* Patients who receive additional analgesic or sedative medication immediately before or during the dressing change outside the standardized clinical protocol.\n* Patients who have previously participated in this study.","ALL","18 Years","100 Years",{"count":90,"type":91},150,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this clinical trial is to learn if personalized natural sound therapy works better than standardized natural sound therapy for reducing procedural pain during negative pressure wound therapy dressing changes. The study will also assess whether personalized and standardized sound therapy differ in their effects on participants' anxiety and physiological responses during the dressing-change procedure.\n\nThe main questions it aims to answer are\n\n* Does personalized natural sound therapy reduce procedural pain more effectively than standardized natural sound therapy during negative pressure wound therapy dressing changes?\n* Does personalized natural sound therapy reduce anxiety during the dressing-change procedure? Researchers will compare personalized natural sound therapy with standardized natural sound therapy to determine whether tailoring the sound intervention to each participant provides greater relief from procedural pain during negative pressure wound therapy dressing changes.\n\nParticipants will:\n\n* Receive either personalized natural sound therapy or standardized natural sound therapy during their negative pressure wound therapy dressing change.\n* Listen to the assigned natural sounds throughout the dressing-change procedure.\n* Report their level of procedural pain using a validated pain assessment scale before, during, and\u002For after the dressing change.\n* Report their anxiety level using a validated anxiety assessment scale.\n* Complete the study assessments according to the scheduled dressing-change procedure.",[97,98],"Pain","Anxiety",[100,101,102,103,104,105],"Personalized","Standarized","Natural Sound Therapy","Procedural Pain","Negative Pressure Wound Therapy","Dressing Changes","NOT_YET_RECRUITING","2026-10-01",{"date":109,"type":110},"2026-10-02","ACTUAL",{"date":112,"type":91},"2026-10-11",{"date":114,"type":91},"2027-01-20",{"name":5,"class":6},1]