open heart surgery.
Conditions
Interventions
Intervention 1: Intervention group: In this two-group randomized clinical trial, patients admitted to the ICU following open-heart surgery were randomly allocated to intervention or control groups. Th
if transferred to the cardiac surgery ward, the intervention continued there. Each 30-minute session comprised six stimulation types:[1]## Stimulation Components- **Auditory**: Patient-preferred music
patients could suck or swallow them to activate gustatory and thermal-tactile pathways in the oral/pharyngeal region.- **Cognitive**: Brief orienting prompts (time/day, location/ward name, staff pres
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between 18 and 75 years. Hospitalized in the Intensive Care Unit (ICU) following open-heart surgery Adequate level of consciousness to report pain (Glasgow Coma Scale [GCS] = 13). Ability to understand the Persian language and cooperate in responding to questions. Provision of written informed consent by the patient or a legal representative. Relative hemodynamic stability (no requirement for high doses of vasopressors or inotropes). Absence of severe auditory, visual, or speech impairments that could interfere with the reception of multisensory stimulation. Safe swallowing ability and absence of significant oral or pharyngeal problems (e.g., severe xerostomia, active oral ulcers, or infections).
Exclusion criteria
Exclusion criteria: Occurrence of acute postoperative complications (such as severe bleeding, cardiac arrest, or life-threatening arrhythmias). Decreased level of consciousness (GCS < 13) during the study period. Requirement for re-intubation or prolonged mechanical ventilation during the intervention. Presence of severe psychiatric disorders or use of strong sedative medications that interfere with appropriate responsiveness. Hemodynamic instability (=20% reduction in blood pressure or heart rate) and/or the need for emergency intervention. Occurrence of unpredictable conditions that disrupt the implementation of the intervention. Development of swallowing disorders or appearance of warning signs such as coughing, nausea, or aspiration during gustatory stimulation. Lack of willingness or withdrawal of consent by the patient or family to continue participation in the study. Postoperative bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative cardiac pain intensity measured using the Numeric Rating Scale (NRS). Timepoint: Before the intervention, immediately after, and 30 minutes after the intervention, during each morning session for four consecutive days; from the third day onward, after transfer to the cardiac surgery ward, the intervention will be conducted in that ward. Method of measurement: using the Numerical Rating Scale (NRS, 0–10), on which the patient reports pain intensity ranging from 0 (no pain) to 10 (the worst pain imaginable).;Hemodynamic indices included systolic and diastolic blood pressure, mean arterial pressure (MAP), heart rate (HR), and peripheral oxygen saturation (SpO2). Timepoint: Before the intervention, immediately after, and 30 minutes after the intervention. Method of measurement: Vital signs were monitored clinically by the attending nurse or researcher, with precise numerical values recorded on a standard checklist. | — |
Secondary
| Measure | Time frame |
|---|---|
| The dose and type of analgesic and opioid medications administered to patients during the intervention period (morphine, fentanyl, methadone, midazolam, propofol and...). Timepoint: Daily during the 4-day intervention period and the total dose of each medication consumed at the end of the intervention period. Method of measurement: Precise recording of medication type, administered dose, and administration time was performed using the patient's medication chart and the drug registration form (designed as per the proposal appendix).;Change in the patient's need for sedative medications post-intervention. Timepoint: Daily, concurrent with the intervention period (days 1 to 4). Method of measurement: Daily sedative prescription status and doses were reviewed and recorded from the patient's medical chart.;Occurrence of any potential adverse events during or after the intervention (hypotension, tachycardia or bradycardia, decreased SpO2, nausea, vomiting, restlessness). Timepoint: During the intervention implementation up to 30 minutes after each intervention session. Method of measurement: Direct observation of the patient and nursing report recording. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNafiseh Nouri
Mashhad University of Medical Sciences
Outcome results
None listed