The Effect of Family Member Voices on Dopamine, Serotonin Levels, and Pain in Patients in Intensive Care Units

February 9, 2026 updated by: Zeliha CENGİZ
In intensive care units, the frequent use of analgesics leads to polypharmacy and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their quality of life. Listening to the voices of family members is expected to have positive effects on patients due to its ease of implementation, low cost, and non-invasive nature.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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

In intensive care units, the frequent use of analgesics leads to excessive medication use and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their quality of life. Listening to the voices of family members is expected to have positive effects on patients due to its ease of implementation, low cost, and non-invasive nature. This study was planned to be conducted between 01.03.2025 and 01.03.2026 at İnönü University Turgut Özal Medical Center General Surgery Intensive Care, Neurology Intensive Care, and Neurosurgery Intensive Care units. The aim was to determine the effects of family members' voices on dopamine and serotonin levels and pain in ICU patients, as well as family members' satisfaction levels. The study was designed as a randomized controlled trial. The sample for the study would consist of 78 ICU patients (experimental group = 39, control group = 39) treated in these clinics, determined by power analysis for the data collection dates. In the experimental group, recordings of emotionally charged voices from family members were played to patients using headphones for a total of 40 minutes, structured as 2 sets of 20 minutes each with a 10-minute rest between applications. In both groups, behavioral pain assessment was planned at 0, 20, and 50 minutes, and dopamine and serotonin levels would be measured from venous blood samples. To collect study data, a Personal Information Form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and a family member satisfaction questionnaire (FS-ICU-24) were used. Power analysis conducted with the G*Power program considered an effect size of 0.20, a significance level of 0.05, a 95% confidence interval, and 0.95 power.

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.
78

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 Locations

  • Turkey (Türkiye)
    • Malatya
      • Malatya, Malatya, Turkey (Türkiye), 44000
        • Malatya Turgut Ozal Medical Center
    • Merkez
      • Şırnak, Merkez, Turkey (Türkiye), 73000
        • Şırnak Üniversitesi

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be between 18 and 65 years old.
  • Must be admitted to an intensive care unit (ICU).
  • Must not have been fed in the last hour.
  • Glasgow Coma Scale (GCS) score between 3 and 8.
  • To agitation in deep coma, the Richmond Agitation-Sedation Scale (RASS) score must be between -3 and +2.

Exclusion Criteria:

  • Having a known hearing-related illness or having undergone a surgical procedure involving the ear.
  • Having taken any of the hormones cortisol, serotonin, or dopamine within the last 48 hours.
  • Having taken any analgesic within the last 4 hours.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: experimental group
In the experimental group, patients were exposed to a protocol consisting of emotional-content audio recordings obtained from close relatives, each 20 minutes long, with a 10-minute rest between applications, arranged as two sets, and delivered via headphones for a total of 40 minutes. In the experimental group, behavioral pain assessments were conducted at 0, 20, and 50 minutes, and dopamine and serotonin levels were measured from venous blood samples. To collect study data, a personal information form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and the FS-ICU-24 patient/family satisfaction questionnaire were used.
Other: Experimental Group
The patients' relatives were given a detailed explanation of the procedures and were asked to fill out a patient/family satisfaction questionnaire. The topics to be discussed by the patient's family members were defined within a framework, and audio recordings were obtained. At 0 minutes, 5 mL of venous blood was drawn to assess dopamine and serotonin levels, and behavioral pain scores were recorded. Between 0 and 20 minutes, for 20 minutes, the audio recordings were played to the patient via headphones, 5 mL of venous blood was drawn again to assess dopamine and serotonin levels, and behavioral pain scores were recorded. At 10 minutes, the headphones were removed and the patient was exposed to normal ICU sounds. Between 30 and 50 minutes, again for 20 minutes, the audio recordings were played to the patient via headphones, 5 mL of venous blood was drawn again to assess dopamine and serotonin levels, and behavioral pain scores were recorded.
No Intervention: control group
In this group, no intervention is performed, and the patients are exposed to ICU sounds. For the control group, at 0 minutes 5 mL (5 cc) of venous blood was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded. From 0 to 20 minutes, no intervention was performed; however, the patients were exposed to intensive-care unit (ICU) sounds for 20 minutes. A 5 mL venous blood sample was drawn again to check dopamine and serotonin levels, and behavioral pain scores were recorded. The patients were then exposed to normal ICU sounds for 10 additional minutes. From 30 to 50 minutes, again without any intervention, patients were exposed to ICU sounds for 20 minutes; a 5 mL venous blood sample was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded.

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
Compared with Baseline, at 20 And 50 Minutes after The Patient-Family Voice Recordings Were Played, Dopamine and Serotonin Levels İncreased and Pain Decreased According to The Behavioral Pain Scale.
Time Frame: Changes in dopamine, serotonin, and pain at 0, 20, and 50 minutes after the patient's family voices were played.
An increase in dopamine and serotonin levels in the venous blood of patients compared with the control group, and a low score on the measured Behavioral Pain Scale relative to baseline (with 10 being the highest and 1 the lowest), would indicate that the audio recordings are a positive intervention.
Changes in dopamine, serotonin, and pain at 0, 20, and 50 minutes after the patient's family voices were played.

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.
Zeliha CENGİZ

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

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.
February 20, 2025

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.
February 20, 2026

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.
February 20, 2026

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).
February 2, 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.
February 9, 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.
February 11, 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.
February 11, 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.
February 9, 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.
February 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.
  • 2024/59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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