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The effect of sensory stimuli modulating on hemodynamic indicators and the level of consciousness of comatose patients

The effect of sensory stimuli modulating on hemodynamic indicators and the level of consciousness of comatose patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240930063216N1
Enrollment
50
Registered
2025-06-01
Start date
2025-06-10
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comatose patients hospitalized to the intensive care unit. Factors influencing health status and contact with health service

Interventions

Intervention 1: Intervention group: Individuals in the intervention group undergo sensory stimulation modulation (auditory stimulation with a familiar sound along with sound and light masking). Interv

Sponsors

Khoram-Abad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Consent to the study by the patient's legal guardian. The age of 18 to 65 years. Level of consciousness = 8 according to the Glasgow Coma Scale and with an Apache score between 10-34

Exclusion criteria

Exclusion criteria: Hearing impairment or any dressing in the ear area Prohibition on the use of earplugs and eye masks. Receiving sedatives or tranquilizers 24 hours before entering the study Death or transfer or dispatch of the patient Sudden change in the patient's condition (such as the need for an operating room, the occurrence of seizures, etc.). Unwillingness to continue the study by the legal guardian

Design outcomes

Primary

MeasureTime frame
Heart rate. Timepoint: Day 0 (before intervention), Day 1, Day 2, Day 3 and Day 4 (after intervention), every day at 8 am as an average of the previous 24 hours. Method of measurement: heart rate are measured using a monitoring device available in the ward, the calibration and health of which is confirmed by a medical equipment engineer.;Mean arterial pressures. Timepoint: Day 0 (before intervention), Day 1, Day 2, Day 3 and Day 4 (after intervention), every day at 8 am as an average of the previous 24 hours. Method of measurement: Mean arterial pressures are measured using a monitoring device available in the ward, the calibration and health of which is confirmed by a medical equipment engineer.;Temperature. Timepoint: Day 0 (before intervention), Day 1, Day 2, Day 3 and Day 4 (after intervention), every day at 8 am as an average of the previous 24 hours. Method of measurement: Temperature are measured using a monitoring device available in the ward, the calibration and health of which is confirmed by a medical equipment engineer.;Arterial blood oxygen saturation. Timepoint: Day 0 (before intervention), Day 1, Day 2, Day 3 and Day 4 (after intervention), every day at 8 am as an average of the previous 24 hours. Method of measurement: Arterial blood oxygen saturation are measured using a monitoring device available in the ward, the calibration and health of which is confirmed by a medical equipment engineer.;Level of consciousness. Timepoint: Day 0 (before intervention), Day 1, Day 2, Day 3 and Day 4 (after intervention), every day at 8 am as an average of the previous 24 hours. Method of measurement: . The patient's level of consciousness is also measured based on the Glasgow Coma Scale.

Secondary

MeasureTime frame
Number of days patients were hospitalized in the intensive care unit. Timepoint: From the time the patient is admitted to the intensive care unit until the time they are discharged from the intensive care unit. Method of measurement: Study and review of the files of the patients studied in the research.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactVida Shirooye

Khoram-Abad University of Medical Sciences

vidashirooye@gmail.com+98 66 4253 8192

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026