Skip to content

Evaluating of the family participation based on affective simulations on improving the level of consciousness patients with brain trauma hospitalized in ICUs: A combined embedded study.

The effect of the family participation based on affective stimulations on improving the level of consciousness patients with brain trauma.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201503048069N3
Enrollment
60
Registered
2016-02-01
Start date
2015-03-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Head trauma. Injuries to the head

Interventions

Intervention 1: In intervention group, family participation through Regular visits and establishing defined communications with the patient as sensory and affective simulations are done by a close mem
Treatment - Other
In intervention group, family participation through Regular visits and establishing defined communications with the patient as sensory and affective simulations are done by a close member of the famil
In placebo group, visit and sensory simulations are made by an unfamiliar trained person who has no affinity, affective and family relations with the patients twice a day (morning and evening). Before
In control group, care and visit would be made as is routine in ICUs (the family visit from behind the window and from the distant). Before and immediately after the intervention, the level of conscio

Sponsors

Vice chancellor for research, University of Tarbiat Modares
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Family inclusion criteria: He/She can be considered as the first degree relative of the patient (father, mother, sister, brother, child, wife/husband) , having the ability of verbal communication with the others, the age of relative would be in the range of 18 and lower than 65 years old. Patients' inclusion criteria: Hospitalizing with Head injury (brain trauma) diagnosis, the level of consciousness based on Glasgow Coma Scale between 5 -8, the age of patient between 18-65 years old. Exclusion criteria: The death of patient during the study, transferring of patient to the other centers during the study, operating a surgery during the study, withdrawing the patient's family to continue to participate in the study, discharge of patient from the unit before 7 days of hospitalization time, having background diseases such as Alzheimer, Parkinson, brain stroke and so on.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Level of consciousness. Timepoint: Twice a day,before and immediately after the intervention. Method of measurement: By Glasgow Coma Scale and Coma Recovery Scale.

Secondary

MeasureTime frame
Length of stay in the intensive care unit. Timepoint: Once, when discharged from ICU. Method of measurement: By Level of Consciousness Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMansoreh Movahedin

Tarbiat Modares University

movahed.m@modares.ac.ir+98 21 8288 4502

Outcome results

None listed

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