Physiological Changes in Adult Intensive Care Patients Following Contact With Their Primary Caregiver (CARE-ICU)
Physiological Changes in Adult Intensive Care Patients Upon Contact With Their Primary Caregiver (CARE-ICU): A Randomized Clinical Trial
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Isabel Álvarez-Solorza, Dr.
- 전화번호: 8038 +52 1 7222231161
- 이메일: ialvarezs@uaemex.mx
연구 장소
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Mexico City
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Mexico City, Mexico City, 멕시코, 14080
- 모병
- Investigación del Instituto Nacional de Enfermedades Respiratorias
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연락하다:
- Anely González-Colín, BSN
- 전화번호: +52 1 5554871700
- 이메일: angonzalezc002@uaemex.mx
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria
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 +3.
- Glasgow Coma Scale score greater than 13.
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.
Exclusion Criteria
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Intervention
Therapeutic physical contact provided by their primary caregiver
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During the pre-visit phase (30 minutes), caregivers will receive information about the study, patient's condition, infection control procedures, and training on the standardized contact protocol. During the visit phase (20 min), the caregiver will greet the patient in a customary manner (1 min); provide a gentle massage to the dorsal surface of the hand while discussing positive events of the day (6 min); gently touch the patient's forehead with the fingertips while recalling pleasant memories (3 min); gently massage the patient's cheek using the fingertips while providing encouraging and positive messages (3 minutes); massage the palm of the patient's hand using circular movements while discussing goals to be achieved after hospital discharge (4 min); and holding the patient's hand and expressing wishes for recovery and discharge (3 min). Following the visit, caregivers will be given the opportunity to share observations, comments, and feedback regarding the intervention experience.
다른 이름들:
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간섭 없음: Standard Care Without Therapeutic Contact
Standard intensive care unit care without the standardized therapeutic physical contact intervention provided by the primary caregiver.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Heart Rate
기간: 10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.
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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.
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10 minutes before the intervention, during the intervention (10 minutes after the start of the visit), and 10 minutes after the intervention.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Systolic Blood Pressure
기간: 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.
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Systolic blood pressure, defined as the maximum arterial pressure during cardiac contraction, measured in millimeters of mercury (mmHg).
Measurements will be obtained using a bedside multiparameter monitor through a blood pressure cuff or arterial line.
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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.
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Change in Diastolic Blood Pressure
기간: 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.
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Diastolic blood pressure, defined as the minimum arterial pressure during cardiac relaxation, measured in millimeters of mercury (mmHg).
Measurements will be obtained using a bedside multiparameter monitor through a blood pressure cuff or arterial line.
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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.
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Change in Respiratory Rate
기간: 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.
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Respiratory rate, defined as the number of breaths per minute (breaths/min), measured using a bedside multiparameter monitor through cutaneous electrodes.
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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.
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Change in Oxygen Saturation
기간: 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.
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Oxygen saturation, defined as the percentage of arterial hemoglobin saturated with oxygen (SpO₂), measured using a pulse oximeter placed on the patient's finger under conditions free of movement interference.
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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.
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Change in Body Temperature
기간: 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.
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Body temperature, defined as the degree of body heat expressed in degrees Celsius (°C), measured in the axillary region using a temperature probe connected to a bedside multiparameter monitor.
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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.
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Isabel Álvarez-Solorza, RN, PhD, Universidad Autonoma del Estado de Mexico
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- C23-26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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