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

NCT07404813 | Enrolling By Invitation

• 1 other identifier: 2024/59
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Patient Engagement; Intensive Care (ICU); Family Members' Voices

Keywords

Relatives' Voices; Pain,; serotonin; Dopamine; Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

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.

Interventions

Experimental Group OTHER

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.

experimental group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: collaborator
• Zeliha CENGİZ: lead

Study Sites (2)

Malatya Turgut Ozal Medical Center

Malatya, Malatya, 44000, Turkey (Türkiye)

Location

Şırnak Üniversitesi

Şırnak, Merkez, 73000, Turkey (Türkiye)

Location

Related Publications (2)

• Yu WC, Chiang MC, Lin KC, Chang CC, Lin KH, Chen CW. Effects of maternal voice on pain and mother-Infant bonding in premature infants in Taiwan: A randomized controlled trial. J Pediatr Nurs. 2022 Mar-Apr;63:e136-e142. doi: 10.1016/j.pedn.2021.09.022. Epub 2021 Sep 30.

  PMID: 34602338 RESULT

• Tıbık, R., & Şener, D. K. (2024). Preterm Yenidoğanlara Orogastrik Tüp Takma İşlemi Sırasında Dinletilen Anne Sesi ve Beyaz Gürültünün Ağrı Düzeyi ve Fizyolojik Parametrelere Etkisi: Randomize Kontrollü Çalışma. Bandırma Onyedi Eylül Üniversitesi Sağlık Bilimleri ve Araştırmaları Dergisi, 6(1), 109-119.

  RESULT

Related Links

• Tıbık, R. ve Şener, DK (2024). Preterm Yenidoğanlara Orogastrik Tüp Takma İşlemi Sırasında Dinletilen Anne Sesi ve Beyaz yağının Ağrı Düzeyi ve Fizyolojik Parametrelere Etkisi: Rastgele Kontrollü Çalışma.

MeSH Terms

Conditions

Patient Participation; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: 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 both groups, 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 a family/patient relative satisfaction questionnaire (FS-ICU-24) were used. 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

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 11, 2026
• Study Start: February 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: February 20, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)