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Procedural Pain During Endotracheal SuctioningFPSNSTNCT07920029

Effects of Family-Proxy-Selected Natural Sound Therapy Versus Standardized Natural Sound and Noise Reduction on Procedural Pain During Endotracheal Suctioning in Non-Communicative Mechanically Ventilated Adults: A Four-Arm Randomized Controlled Trial

A study testing Family-Proxy-Selected Natural Sound Therapy, Standardized Natural Sound Therapy and Environmental Noise Reduction During Endotracheal Suctioning in people with Procedural Pain During Endotracheal Suctioning, run by University of Basrah at 1 site in Iraq.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Endotracheal suctioning is a common procedure used to remove secretions from the airways of patients receiving mechanical ventilation. Although this procedure is necessary for respiratory care, it may cause pain and discomfort. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Family-Proxy-Selected Natural Sound Therapy, Standardized Natural Sound Therapy and Environmental Noise Reduction During Endotracheal Suctioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIraq
Study dates
13 Nov 2026to 20 Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years or older.
  • Patients admitted to the intensive care unit (ICU).
  • Patients receiving invasive mechanical ventilation through an endotracheal tube.
  • Patients who are unable to communicate verbally or reliably self-report pain.
  • Patients requiring clinically indicated endotracheal suctioning as part of routine respiratory care.
  • Patients for whom behavioral pain assessment using the Critical-Care Pain Observation Tool (CPOT) is feasible.
  • Patients whose legally authorized representative or designated family proxy can provide informed consent in accordance with applicable ethical and institutional requirements.

Who cannot join

  • Patients receiving neuromuscular blocking agents at the time of pain assessment.
  • Patients with conditions that prevent reliable behavioral pain assessment using CPOT.
  • Patients with severe hearing impairment or auditory conditions that would prevent exposure to the sound interventions, if applicable to the intervention delivery method.
  • Patients with severe clinical instability that makes participation in the study procedures unsafe.
  • Patients with an ear condition or other contraindication to the planned sound delivery method.
  • Patients who are simultaneously enrolled in another interventional study that may affect pain assessment or management.
  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ali M Dr. Ali Malik Tiryag, PhD contact

+9647811735332

ali.malik@uobasrah.edu.iq

Iraq1 site
  • College of Nursing, University of Basrah

    Basra

    Sundus B Sundus Baqer Dawood, PhD, +9647707096503, sindus.dawood@uobasrah.edu.iq

Other trials in Iraq

About this study

Endotracheal suctioning is a common procedure used to remove secretions from the airways of patients receiving mechanical ventilation. Although this procedure is necessary for respiratory care, it may cause pain and discomfort. Assessing pain can be challenging in patients who cannot communicate verbally, making appropriate pain assessment and management particularly important.

Natural sounds, such as sounds from nature, may offer a non-pharmacological approach to reducing procedural pain. Selecting sounds based on family members' knowledge of a patient's preferences may provide a more personalized approach, while standardized natural sounds may offer a consistent alternative. Noise reduction may also help limit unnecessary environmental sound exposure during the procedure.

Read more

This four-arm randomized controlled trial will compare the effects of family-proxy-selected natural sound therapy, standardized natural sound therapy, noise reduction, and the designated control condition on procedural pain during endotracheal suctioning in non-communicative adults receiving mechanical ventilation.

Eligible participants will be randomly assigned to one of the four study groups. Pain will be assessed using a prespecified instrument appropriate for non-communicative critically ill patients. The study will compare pain outcomes across the groups to determine whether family-proxy-selected natural sounds, standardized natural sounds, or noise reduction are associated with lower procedural pain.

The findings may help inform non-pharmacological approaches to procedural pain management in mechanically ventilated adults who cannot communicate their pain verbally.

Read the detailed description

Background and Rationale

Endotracheal suctioning is frequently performed in mechanically ventilated patients to maintain airway patency and remove accumulated respiratory secretions. Despite its clinical importance, suctioning can be associated with pain and physiological stress. Patients who are unable to communicate verbally may be particularly vulnerable because they cannot directly describe the intensity or nature of their pain.

Pain assessment in non-communicative critically ill patients therefore requires systematic observation using an appropriate validated behavioral pain assessment instrument. In addition to routine clinical pain management, non-pharmacological interventions may provide supportive strategies for reducing procedural pain.

Natural sound therapy is a potential non-pharmacological intervention that may help reduce distress during painful or uncomfortable procedures. However, the effect of natural sounds may depend on the type of sound used and its relevance to the individual patient. Family members may provide useful information about a patient's familiar sounds and preferences when the patient cannot communicate these preferences directly. Family-proxy-selected natural sounds may therefore offer a personalized approach, whereas standardized natural sounds provide a more uniform intervention that can be delivered consistently across participants.

Environmental noise reduction represents a separate approach that focuses on minimizing unnecessary sound exposure rather than introducing therapeutic sounds. Comparing these strategies may help clarify their respective effects on procedural pain during endotracheal suctioning.

Study Objective

The primary objective is to compare procedural pain during endotracheal suctioning among non-communicative, mechanically ventilated adults assigned to family-proxy-selected natural sound therapy, standardized natural sound therapy, noise reduction, or the protocol-defined control condition.

The study will evaluate whether these approaches differ in their effects on observed procedural pain. The results may contribute to evidence-based nursing care for critically ill patients who cannot communicate verbally.

Study Design

This study is a four-arm randomized controlled trial involving non-communicative adults receiving mechanical ventilation who require endotracheal suctioning. Eligible participants will be randomly allocated to one of four groups according to the study's randomization procedure.

The four groups will be defined as follows:

  1. Family-Proxy-Selected Natural Sound Therapy Group: Participants will receive natural sound therapy using sounds selected by a family member or designated proxy based on the proxy's knowledge of the patient's preferences or familiarity with particular sounds.
  2. Standardized Natural Sound Therapy Group: Participants will receive a predefined natural sound intervention selected by the research team according to a standardized protocol.
  3. Noise Reduction Group: Participants will receive the protocol-defined environmental noise reduction intervention during the relevant procedural period. The intervention will focus on reducing unnecessary environmental sound exposure.
  4. Control Group: Participants will receive the standard care specified in the study protocol without the additional intervention assigned to the other groups.

The precise intervention procedures, timing, duration, sound delivery method, and control condition will follow the finalized study protocol.

Study Population

The study population will consist of adults receiving invasive mechanical ventilation who are unable to communicate their pain verbally and require endotracheal suctioning. Participants will be screened against prespecified eligibility criteria before enrollment.

Outcome Assessment

The primary outcome will be procedural pain associated with endotracheal suctioning. Pain will be assessed using the behavioral pain assessment instrument specified in the protocol and appropriate for non-communicative critically ill adults. Assessments will be conducted at prespecified time points in relation to the suctioning procedure.

The study will compare pain scores across the four randomized groups according to the prespecified statistical analysis plan. Any secondary outcomes, additional physiological measurements, assessment time points, and safety assessments will be defined in the finalized protocol and registered in the appropriate outcome fields.

Potential Significance

This study will provide a comparative evaluation of three non-pharmacological approaches to procedural pain management in mechanically ventilated adults who cannot communicate verbally. By examining personalized natural sound therapy, standardized natural sound therapy, and environmental noise reduction within a randomized design, the study may help identify approaches that can be considered as supportive components of nursing care during endotracheal suctioning.

These interventions are intended to be evaluated within the context of appropriate routine clinical care and should not replace indicated analgesia, established pain assessment, or other necessary clinical management.

Being tested
Family-Proxy-Selected Natural Sound Therapy, Standardized Natural Sound Therapy, Environmental Noise Reduction During Endotracheal Suctioning
Keywords
Family-Proxy-Selected, Natural Sound Therapy, Standardized Natural Sound, Noise Reduction, Procedural Pain, Endotracheal Suctioning, Non-Communicative Mechanically Ventilated Adults
Medical subject headings
Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family-Proxy-Selected Natural Sound TherapyBehavioural

    Natural sound therapy tailored to the individual participant using sounds selected by a family member or designated proxy based on their knowledge of the participant's preferences or familiarity with particular natural sounds. The sounds will be delivered during endotracheal suctioning according to the study protocol. The protocol will specify sound selection procedures, delivery equipment, sound intensity, duration, and timing in relation to suctioning. Routine clinical care and indicated pain management will continue.

  • Standardized Natural Sound TherapyBehavioural

    A standardized natural sound intervention using predefined natural sounds selected by the research team. The same sound protocol will be applied to participants assigned to this group during endotracheal suctioning. The study protocol will specify the sound content, delivery equipment, sound intensity, duration, and timing in relation to the procedure. Routine clinical care and indicated pain management will continue.

  • Environmental Noise Reduction During Endotracheal SuctioningBehavioural

    An environmental noise reduction intervention implemented during endotracheal suctioning according to a predefined study protocol. The intervention will focus on minimizing unnecessary environmental sound exposure without introducing the natural sound therapy used in the other intervention groups. The protocol will specify the noise reduction measures and their timing. Routine clinical care and indicated pain management will continue.

Study groups in NCT07920029
Study groupRoleWhat they receive
Family-Proxy-Selected Natural Sound TherapyExperimentalParticipants will receive natural sound therapy using sounds selected by a family member or designated proxy based on their knowledge of the participant's preferences or familiarity with particular natural sounds. The sounds will be delivered according to the study protocol during the endotracheal suctioning procedure. Routine clinical care, including indicated pain management, will continue.
Receives: Behavioral: Family-Proxy-Selected Natural Sound Therapy
Standardized Natural Sound TherapyExperimentalParticipants will receive a standardized natural sound intervention selected in advance by the research team. The same predefined sound protocol will be applied to participants assigned to this group during the endotracheal suctioning procedure. Routine clinical care, including indicated pain management, will continue.
Receives: Behavioral: Standardized Natural Sound Therapy
Environmental Noise ReductionExperimentalParticipants will receive an environmental noise reduction intervention during the endotracheal suctioning procedure, according to the study protocol. The intervention will focus on reducing unnecessary environmental noise without introducing the natural sound therapy used in the other intervention groups. Routine clinical care, including indicated pain management, will continue.
Receives: Behavioral: Environmental Noise Reduction During Endotracheal Suctioning
Usual Care Control GroupNo interventionParticipants will receive usual clinical care during endotracheal suctioning according to the participating clinical unit's standard procedures. No additional study-specific natural sound therapy or environmental noise reduction intervention will be provided. All clinically indicated pain assessment, analgesia, and other necessary care will continue.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural Pain Score During Endotracheal Suctioning

    Procedural pain will be assessed using the Critical-Care Pain Observation Tool (CPOT), a behavioral pain assessment instrument for critically ill patients who cannot communicate verbally. The CPOT score will be recorded during endotracheal suctioning according to the study protocol. Scores will be compared among the four randomized groups to evaluate differences in procedural pain. The instrument will be administered and scored according to its established instructions.

    Measured: 5 minutes before suctioning (baseline), during suctioning (at the point of greatest observed pain-related behavior), and 5 minutes after completion of suctioning.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start13 Nov 2026 (estimated)
  3. Primary completion20 Mar 2027 (estimated)
  4. Study completion20 Apr 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a four-arm, parallel-group randomized controlled trial. Participants will be randomly assigned to one of four groups: family-proxy-selected natural sound therapy, standardized natural sound therapy, environmental noise reduction, or the protocol-defined control condition. Each participant will receive the intervention assigned to their group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920029
Sponsor's protocol ID
3/7/1674
Acronym
FPSNST
Status last verified
Oct 2026
First submitted
31 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with other researchers. The study data will be used exclusively for the purposes of the present research. Participant confidentiality and data privacy will be maintained in accordance with institutional ethical requirements and applicable data protection regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Family-Proxy-Selected Natural Sound Therapy, Standardized Natural Sound Therapy and Environmental Noise Reduction During Endotracheal Suctioning in people with Procedural Pain During Endotracheal Suctioning, 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 7 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 5 Nov 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 Score During Endotracheal Suctioning (time frame: 5 minutes before suctioning (baseline), during suctioning (at the point of greatest observed pain-related behavior), and 5 minutes after completion of suctioning.). 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 5 Nov 2026.

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