The Effect of Family Member Voices on Dopamine, Serotonin Levels, and Pain in Patients in Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •To agitation in deep coma, the Richmond Agitation-Sedation Scale (RASS) score must be between -3 and +2.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Experimental Group (Other)
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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Zeliha CENGİZ
Associate Professor Dr.
Inonu University