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 (FPSNST)

October 31, 2026 updated by: Ali Malik Tiryag, University of Basrah

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Iraq
      • Basra, Iraq
        • College of Nursing, University of Basrah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

**Inclusion Criteria**

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

**Exclusion Criteria**

  1. Patients receiving neuromuscular blocking agents at the time of pain assessment.

  2. Patients with conditions that prevent reliable behavioral pain assessment using CPOT.

  3. Patients with severe hearing impairment or auditory conditions that would prevent exposure to the sound interventions, if applicable to the intervention delivery method.

  4. Patients with severe clinical instability that makes participation in the study procedures unsafe.

  5. Patients with an ear condition or other contraindication to the planned sound delivery method.

  6. Patients who are simultaneously enrolled in another interventional study that may affect pain assessment or management.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Family-Proxy-Selected Natural Sound Therapy

Participants 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.
Behavioral: Family-Proxy-Selected Natural Sound Therapy

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.
Experimental: Standardized Natural Sound Therapy

Participants 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.
Behavioral: Standardized Natural Sound Therapy

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.
Experimental: Environmental Noise Reduction

Participants 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.
Behavioral: Environmental Noise Reduction During Endotracheal Suctioning

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.
No Intervention: Usual Care Control Group

Participants 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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Basrah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3/7/1674

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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