NCT07404813

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Zeliha CENGİZ · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

2 sites across 1 country: Turkey (Türkiye)