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IRCT20261003071276N1 IRCT 2026-11-04 Hamedan University of Medical Sciences Can family participation help prevent delirium and improve sleep in ICU patients? The Effect of Family Participation in Patient Care on Delirium Prevention and Sleep Quality of Patients Hospitalized in Intensive Care Units of Shahid Beheshti Educational and Therapeutic Center 2026-11-11 anticipated 60 Pending https://irct.ir/trial/93810 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Random allocation of patients to the intervention and control groups is performed using block randomization with a block size of 4. The random sequence is generated using a random number table. For allocation concealment, opaque, sealed, and numbered envelopes are used. The envelopes are opened sequentially as patients are enrolled, and based on the content inside the envelope, the patient is assigned to either the intervention or control group, Blinding description: This study is single-blind, and only the outcome assessor is blinded to group allocation. The assessor of delirium (CAM-ICU) and sleep quality (RCSQ) is unaware of whether the patient is in the intervention or control group. To maintain blinding, the assessor does not attend family training sessions or intervention sessions and performs assessments using patient identification codes rather than names or group labels. The assessor is also not informed about the exact study hypotheses and only completes the assessment tools according to the protocol. The principal investigator who delivers the intervention does not participate in outcome assessment. N/A Delirium. Intervention 1: Control group: Patients in the control group receive routine ICU care according to the hospital’s current protocols and the treating team’s orders. Family presence in this group follows the usual ICU policy, and no structured family participation program is implemented. The family-centered intervention designed in this study (including regular presence in three shifts, caregiver training, and specific care activities) is not performed in the control group. However, delirium incidence is assessed using CAM-ICU and sleep quality using RCSQ at the same timepoints as the intervention group (baseline, Days 1–3, and continued until ICU discharge if applicable). Other treatments, medications, and clinical care continue as ordered by the treating team. Intervention 2: Intervention group: Patients in the intervention group receive routine ICU care plus a structured family participation program. One first-degree family member attends a 30–45 minute training session, then is present at the bedside for 3 consecutive days (or until ICU discharge), 3 times daily (morning, evening, night), about 60 minutes per session. Activities include calm verbal communication, therapeutic touch, talking about positive memories, using hearing aids/glasses, assisting with simple care under nurse supervision, encouraging mobilization, and night presence for relaxation and sleep preparation. Supplementary measures such as reducing light/noise and regulating sleep-wake cycle are also taught. Delirium is assessed with CAM-ICU and sleep quality with RCSQ at the same timepoints as the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of participants' medical information and the need to protect patients' privacy, individual participant data will not be made publicly available. Study findings will be reported in aggregated form without identifying individual participants.
public Ali Afshari
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pazhohesh Square, Hamadan, Iran
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0717 afshari777@gmail.com Hamedan University of Medical Sciences scientific Ali Afshari
Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pazhohesh Square, Hamadan, Iran
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0717 afshari777@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Key inclusion criteria before randomization for patients include admission to the Intensive Care Unit (ICU) of Shahid Beheshti Educational and Therapeutic Center in Hamadan, age ≥ 18 years, expected ICU stay of at least 72 hours, no delirium at baseline according to CAM-ICU, adequate level of consciousness for delirium assessment (RASS ≥ -3), having at least one first-degree family member (spouse, child, parent, sibling) willing and able to participate in the care program, and written informed consent from the patient or legal guardian and the family member. For the family member, criteria include age ≥ 18 years, being a first-degree relative, ability to attend regularly in three shifts (morning, evening, night) according to the study schedule, ability to communicate effectively with the patient, no acute or contagious infectious disease preventing ICU presence, and willingness to participate and sign the informed consent form. Randomization to the intervention and control groups is performed only after all these criteria are met and informed consent is obtained. 18 years no limit Both Key exclusion criteria before randomization for patients include age < 18 years, expected ICU stay < 72 hours, presence of delirium at baseline according to CAM-ICU, level of consciousness lower than RASS -3, absence of at least one first-degree family member (spouse, child, parent, sibling) willing and able to participate in the care program, and lack of written informed consent from the patient or legal guardian and the family member. For family members, exclusion criteria include age < 18 years, not being a first-degree relative, inability to attend regularly in three shifts (morning, evening, night) according to the study schedule, inability to communicate effectively with the patient, acute or contagious infectious disease preventing ICU presence, and unwillingness to participate or failure to sign the informed consent form. F05.9 Delirium, unspecified Other Other Control group: Patients in the control group receive routine ICU care according to the hospital’s current protocols and the treating team’s orders. Family presence in this group follows the usual ICU policy, and no structured family participation program is implemented. The family-centered intervention designed in this study (including regular presence in three shifts, caregiver training, and specific care activities) is not performed in the control group. However, delirium incidence is assessed using CAM-ICU and sleep quality using RCSQ at the same timepoints as the intervention group (baseline, Days 1–3, and continued until ICU discharge if applicable). Other treatments, medications, and clinical care continue as ordered by the treating team. Intervention group: Patients in the intervention group receive routine ICU care plus a structured family participation program. One first-degree family member attends a 30–45 minute training session, then is present at the bedside for 3 consecutive days (or until ICU discharge), 3 times daily (morning, evening, night), about 60 minutes per session. Activities include calm verbal communication, therapeutic touch, talking about positive memories, using hearing aids/glasses, assisting with simple care under nurse supervision, encouraging mobilization, and night presence for relaxation and sleep preparation. Supplementary measures such as reducing light/noise and regulating sleep-wake cycle are also taught. Delirium is assessed with CAM-ICU and sleep quality with RCSQ at the same timepoints as the control group. Delirium incidence: Delirium incidence in patients admitted to intensive care units, assessed daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). A positive CAM-ICU result will be considered as the presence of delirium, while a negative result will indicate the absence of delirium. Timepoint: Daily assessment using CAM-ICU, at baseline (before intervention) and then daily on Days 1, 2, and 3 of the intervention. If hospitalization continues, assessment continues until ICU discharge. Method of measurement: Incidence of delirium is assessed daily at a fixed time by a trained researcher using the Persian version of the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit). Before assessment, the patient’s level of consciousness is evaluated using the RASS (Richmond Agitation-Sedation Scale); if RASS ≥ -3, the CAM-ICU is performed. The result is recorded as presence/absence of delirium. Assessment is performed at baseline (before intervention) and then daily on Days 1–3 of the intervention; if hospitalization continues, it is continued until ICU discharge. Sleep quality: Sleep quality in patients admitted to intensive care units, assessed daily using the Richards-Campbell Sleep Questionnaire (RCSQ). A higher score indicates better sleep quality. Timepoint: Assessed every morning using RCSQ, at baseline (before intervention) and then every morning on Days 1, 2, and 3 of the intervention. If hospitalization continues, assessment continues until ICU discharge. Method of measurement: Measured every morning using the Persian version of the RCSQ (Richards-Campbell Sleep Questionnaire). The RCSQ contains 5 items, each scored on a 0–100 mm visual analogue scale (VAS). The mean of the 5 item scores is calculated as the overall sleep quality score (0–100); higher scores indicate better sleep quality. Measurement is performed at baseline and then every morning on Days 1–3 of the intervention; if hospitalization continues, it is continued until ICU discharge. Length of ICU stay. Timepoint: From study enrollment until ICU discharge, transfer, or death (single assessment at the end of ICU stay). Method of measurement: Number of days the patient stays in the ICU from study enrollment until ICU discharge, transfer to another ward, or death. Data are extracted from the medical record and hospital information system and recorded in days. Duration of mechanical ventilation. Timepoint: From initiation of mechanical ventilation until weaning/discontinuation (recorded at the end of the ventilation period). Method of measurement: Total duration of mechanical ventilation from initiation until successful weaning or discontinuation. Data are extracted from the medical record and mechanical ventilation flow sheet and recorded in days (or hours converted to days). This variable is measured only for patients receiving mechanical ventilation. Sedative drug consumption. Timepoint: Recorded daily and summed at the end of ICU stay (or recorded cumulatively once at ICU discharge). Method of measurement: Total dose of sedative agents (e.g., midazolam, propofol, morphine, and other prescribed sedatives) administered during ICU stay. Data are extracted from the medication record and hospital pharmacy information system and recorded in milligrams or number of doses. If multiple agents are used, the total equivalent dose or total number of doses can be recorded. Hamedan University of Medical Sciences Approved 2026-09-28 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pazhohesh Square, Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)