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NCT07854717
Natural Sound Therapy on Procedural Pain and Anxiety During Negative Pressure Wound Therapy Dressing Changes
Conditions: Pain, Anxiety
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: University of Basrah
Location: College of Nursing, University of Basrah Basra Basrah
Summary
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.
The main questions it aims to answer are
* Does personalized natural sound therapy reduce procedural pain more effectively than standardized natural sound therapy during negative pressure wound therapy dressing changes?
* 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.
Participants will:
* Receive either personalized natural sound therapy or standardized natural sound therapy during their negative pressure wound therapy dressing change.
* Listen to the assigned natural sounds throughout the dressing-change procedure.
* Report their level of procedural pain using a validated pain assessment scale before, during, and/or after the dressing change.
* Report their anxiety level using a validated anxiety assessment scale.
* Complete the study assessments according to the scheduled dressing-change procedure.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 18 years or older.
* Patients receiving negative pressure wound therapy requiring a dressing change.
* Patients who are able to communicate verbally and understand the study procedures.
* Patients who are able to report their pain and anxiety using the study assessment tools.
* Patients who provide informed consent to participate in the study.
Exclusion Criteria:
* Patients with cognitive impairment or altered level of consciousness that prevents reliable communication or outcome assessment.
* Patients who are unable to understand the study instructions or complete the required assessments.
* Patients receiving deep sedation or general anesthesia during the dressing change.
* Patients with severe hearing impairment that prevents them from receiving the auditory intervention.
* Patients with an acute medical condition requiring immediate intervention that would interfere with the study procedure or assessments.
* Patients who receive additional analgesic or sedative medication immediately before or during the dressing change outside the standardized clinical protocol.
* Patients who have previously participated in this study.
Source: ClinicalTrials.gov (NCT07854717). StuddyBuddy aggregates publicly available trial information.