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

NCT07854717 | Not Yet Recruiting DMC

• 1 other identifier: 1/3/5/199
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Anxiety

Keywords

Personalized; Standarized; Natural Sound Therapy; Procedural Pain; Negative Pressure Wound Therapy; Dressing Changes

Outcome Measures

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

  pre-intervention, during intervention, immediately after the intervention

Secondary Outcomes (1)

• Procedural anxiety

  pre-intervention, during intervention, immediately after the intervention

Study Arms (3)

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.

Behavioral: Personalized Natural Sound Therapy

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.

Behavioral: Standardized Natural Sound Therapy

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.

Interventions

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.

Personalized Natural Sound Therapy

Standardized Natural Sound Therapy BEHAVIORAL

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

Standardized Natural Sound Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Basrah: lead

Study Sites (1)

College of Nursing, University of Basrah

Basra, Basrah, 61004, Iraq

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Ali M Dr. Ali Malik Tiryag, PhD

CONTACT

+9647811735332; ali.malik@uobasrah.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Lecturer

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 11, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)