Natural Sound Therapy on Procedural Pain and Anxiety During Negative Pressure Wound Therapy Dressing Changes

ConditionsPainAnxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Basrah

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized Natural Sound Therapy

    Behavioral

    Participants will listen to a natural sound selected according to their individual preference during the negative pressure wound therapy dressing change.

  • Standardized Natural Sound Therapy

    Behavioral

    Participants will listen to the same predetermined natural sound during the negative pressure wound therapy dressing change.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Personalized Natural Sound TherapyExperimental treatment 1 intervention
Group B: Standardized Natural Sound TherapyActive comparator 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
pre-intervention, during intervention, immediately after the intervention

Secondary outcomes

1

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.

Time frame
pre-intervention, during intervention, immediately after the intervention

Other outcomes

Sponsors and contacts

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