PainNPAWTDCNCT07854717
Natural Sound Therapy on Procedural Pain and Anxiety During Negative Pressure Wound Therapy Dressing Changes
A study testing Personalized Natural Sound Therapy and Standardized Natural Sound Therapy in people with Pain and Anxiety, run by University of Basrah at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- Personalized Natural Sound Therapy and Standardized Natural Sound Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIraq
- Study dates
- 11 Oct 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
College of Nursing, University of Basrah
Basra, Basrah, 61004
Sundus B Sundus Baqer Dawood, PhD, +9647707096503, sindus.dawood@uobasrah.edu.iq
About this study
Official title: Effects of Personalized Versus Standardized Natural Sound Therapy on Procedural Pain and Anxiety During Negative Pressure Wound Therapy Dressing Changes: A Randomized Controlled 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
Read more
- 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.
Read the detailed description
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.
Negative 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.
In 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.
The 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.
Before 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.
To 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.
The 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.
- Being tested
- Personalized Natural Sound Therapy, Standardized Natural Sound Therapy
- Keywords
- Personalized, Standarized, Natural Sound Therapy, Procedural Pain, Negative Pressure Wound Therapy, Dressing Changes
- Medical subject headings
- Pain, Anxiety Disorders, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Natural Sound TherapyBehavioural
Participants will listen to a natural sound selected according to their individual preference during the negative pressure wound therapy dressing change.
Standardized Natural Sound TherapyBehavioural
Participants will listen to the same predetermined natural sound during the negative pressure wound therapy dressing change.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: pre-intervention, during intervention, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start11 Oct 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basrah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Malik Tiryag, University of Basrah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07854717
- Sponsor's protocol ID
- 1/3/5/199
- Acronym
- NPAWTDC
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the study does not currently include a plan for external sharing of participant-level data. De-identified aggregate study results will be reported in accordance with applicable ethical, privacy, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Personalized Versus Standardized Natural Sound Therapy on Procedural Pain and Anxiety During Negative Pressure Wound Therapy Dressing Changes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07854717
- Acronym / sponsor ID
- NPAWTDC / 1/3/5/199
- Keywords
- Personalized, Standarized, Natural Sound Therapy, Procedural Pain, Negative Pressure Wound Therapy, Dressing Changes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BasrahUniversity, hospital or other
- Study start
- 11 Oct 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Negative 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.
In 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.
The 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.
Before 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.
To 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.
The 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Personalized Natural Sound Therapy | Experimental | Behavioral: Personalized Natural Sound TherapyParticipants 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. |
| Standardized Natural Sound Therapy | Active comparator | Behavioral: Standardized Natural Sound TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Natural Sound TherapyParticipants will listen to a natural sound selected according to their individual preference during the negative pressure wound therapy dressing change. | Behavioural | Personalized Natural Sound Therapy |
| Standardized Natural Sound TherapyParticipants will listen to the same predetermined natural sound during the negative pressure wound therapy dressing change. | Behavioural | Standardized Natural Sound Therapy |
Primary outcome
Procedural pain intensity during negative pressure wound therapy dressing change
Time frame: pre-intervention, during intervention, immediately after the intervention
Pain intensity experienced by participants during the negative pressure wound therapy dressing change, assessed using the Visual Analogue Scale
1 secondary outcome
Procedural anxiety
Time frame: pre-intervention, during intervention, immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the study does not currently include a plan for external sharing of participant-level data. De-identified aggregate study results will be reported in accordance with applicable ethical, privacy, and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Natural Sound Therapy and Standardized Natural Sound Therapy in people with Pain and Anxiety, run by University of Basrah at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali M Dr. Ali Malik Tiryag, PhD (+9647811735332, ali.malik@uobasrah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural pain intensity during negative pressure wound therapy dressing change (time frame: pre-intervention, during intervention, immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.