The Effect of Family Member Voices on Dopamine, Serotonin Levels, and Pain in Patients in Intensive Care Units
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Group.
- Who it may be relevant to
- Registry conditions: Patient Engagement, Intensive Care (ICU), Family Members' Voices. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 he
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Turkey (Türkiye) · 2 centers
- Malatya Turgut Ozal Medical Center — Malatya
- Şırnak Üniversitesi — Şırnak
Publications
- 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
- 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.
Identifiers
NCT: NCT07404813 · 2024/59