Physiological Changes in Adult Intensive Care Patients Upon Contact With Their Primary Caregiver (CARE-ICU): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Heart Rate
研究概览
简要总结
Patients admitted to intensive care units are exposed to multiple environmental and clinical factors that may affect their physiological responses. This randomized controlled trial aims to evaluate the effect of physical contact with the primary caregiver on physiological parameters in adult patients hospitalized in an intensive care unit.
详细描述
This study is a randomized, controlled, parallel-group, double-blind clinical trial designed to evaluate the effect of therapeutic contact provided by the primary caregiver on physiological parameters in adult intensive care unit (ICU) patients. Participants will be randomly assigned in a 1:1 ratio to either the intervention group (therapeutic contact) or the control group (no therapeutic contact) using block randomization generated by an independent external advisor. Allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed, tamper-evident envelopes.
Sample size was calculated for the comparison of means between two independent groups using a 95% confidence level (α = 0.05), 80% statistical power (β = 0.20), a standard deviation of 7.6, and a minimum clinically meaningful difference of 5 units. The estimated sample size was 36 participants per group. After adjustment for an anticipated 10% attrition rate, a total of 80 participants (40 per group) will be enrolled.
Physiological outcomes include heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, oxygen saturation, and body temperature. Measurements will be obtained using a bedside multiparameter monitor and recorded on a standardized physiological data collection form. Equipment calibration will be verified before each measurement. Outcomes will be assessed 10 minutes before the caregiver visit, 10 minutes after the start of the visit, and 10 minutes after completion of the visit.
Changes in physiological outcomes will be calculated as the difference between baseline measurements and subsequent assessments. Data analysis will be performed using IBM SPSS Statistics Version 29.0 (IBM Corp., Armonk, NY, USA). Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, according to data distribution. Categorical variables will be summarized using frequencies and percentages. Normality will be evaluated using the Kolmogorov-Smirnov test. For each physiological outcome, change scores will be calculated by subtracting baseline values from measurements obtained during and after the caregiver visit. Mean changes between the intervention and control groups will be compared using the independent-samples t-test or the Mann-Whitney U test, as appropriate. Effect sizes will be estimated using Cohen's d. Statistical significance will be established at p < 0.05. The study was approved by the Research Ethics Committee of the Instituto Nacional de Enfermedades Respiratorias "Ismael Cosío Villegas". The trial will be conducted in accordance with the Declaration of Helsinki and applicable Mexican regulations governing health research. Written informed consent will be obtained from all participants or their legally authorized representatives before enrollment. Adverse events will be documented and reported to the institutional ethics committee and ClinicalTrials.gov according to applicable regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Criteria:
- •Adults aged 18 years or older.
- •Admission to the intensive care unit (ICU) for 24 to 48 hours.
- •Richmond Agitation-Sedation Scale (RASS) score between -3 and -1 or between 0 and +
- •Glasgow Coma Scale score greater than
- •Primary Caregiver Criteria:
- •Identified as the patient's primary caregiver.
- •Willing and able to participate in the study.
- •Provides written informed consent prior to study participation.
排除标准
- •Patient Criteria:
- •Diagnosis of a neurological disorder (e.g., cerebrovascular disease or stroke).
- •Multiple organ dysfunction syndrome (MODS).
- •Unstable or difficult-to-control cardiac arrhythmias.
- •Fever (body temperature ≥ 37.5°C) at the time of assessment.
- •Hypertension (blood pressure ≥ 130/80 mmHg) at the time of assessment.
- •Primary Caregiver Criteria:
- •- Unable to be present to perform the intervention according to the study protocol.
研究组 & 干预措施
Intervention
Therapeutic physical contact provided by their primary caregiver
干预措施: Standardized therapeutic physical contact (Other)
Standard Care Without Therapeutic Contact
Standard intensive care unit care without the standardized therapeutic physical contact intervention provided by the primary caregiver.
结局指标
主要结局
Change in Heart Rate
时间窗: 10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.
Heart rate, expressed as beats per minute (bpm), measured using a bedside multiparameter monitor through cutaneous electrodes. Changes in heart rate will be assessed before, during, and after the intervention.
次要结局
- Change in Systolic Blood Pressure(10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.)
- Change in Diastolic Blood Pressure(10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.)
- Change in Respiratory Rate(10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.)
- Change in Oxygen Saturation(10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.)
- Change in Body Temperature(10 minutes before the caregiver visit, during the visit (10 minutes after the start of the caregiver visit), 10 minutes after completion of the caregiver visit.)
研究者
Liliana Argueta-Figueroa
Professor-Researcher
Universidad Autonoma del Estado de Mexico