The aim of this study is to identify the effect of conducted family meeting on the level of consciousness in comatose patients with traumatic brain. The sample consisted of 64 patients with focal brain lesions following head injury are admitted in the intensive care units of Al-Zahra and Kashani hospital. Patients in the intervention and control groups (each n = 32) will be placed with randomization. Selection criteria included patients aged 65-15 with a Glasgow Coma Scale score of 8-5 within 24 hours after admission and not to have a history of hospitalization in the ICU. Patient in intervention group receive auditory and tactile stimulation for 45-60 minutes once the patient is meted with a family member for 14 days. In control group, in routine way, meetings with the family will be every other day for 30 minutes. Conciousness level will be measured a half hour before and after each meeting (twice daily) with Glasgow Coma Scale score and 4 score. The mean GCS score and 4score before and after the meetings is statistically determined and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091719208N1
Registration date:2015-01-25, 1393/11/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-25, 1393/11/05
Registrant information
Name
Pourandokht Pourkermanian
Name of organization / entity
Yazd SHahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 0171
Email address
p.pourkermanian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaheed Sadoughi University Of Medical Sciences and Health Services, Yazd, Iran.
Expected recruitment start date
2014-09-27, 1393/07/05
Expected recruitment end date
2014-12-26, 1393/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of conducted meeting of family on the level of consciousness patients in ICU
Public title
Guided visit family impact awareness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Coma associated with scalp focal damage; patients aged 65-18 years; GCS 5-8; less than 24 hours of admission in ICU.
Exclusion Criteria:
History of hospitalization in ICU.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd University of Medical Sciences and Health Services martyr
Street address
Yazd-of-the-art martyr doctor at the Central University of Medical Sciences and Health Services, Tel 7240171 Fax: 7254750 8916978477 martyr Sadooghi Yzdkdpsty
Daily, half an hour before and after the intervention.
Method of measurement
Glasgow coma scale and 4scoure
Secondary outcomes
empty
Intervention groups
1
Description
Daily conducted family meeting, 45 minutes to an hour (at 17-16 o'clock) for 14 days. In a training session, one of the family member with more emotional relationship with the patient will be trained about the general condition, ICU equipments, infection control necessarily met during the meeting, sensory stimulation can be used and expression of effective sentences. In the first meeting, family member accompanied by researcher. After mentally and emotionally stability, the researcher explains and practically demonstrates expected arrangement of care.
Category
Rehabilitation
2
Description
The control group received the usual meeting in accordance with the rules of ICU. Three times a week, 30 minutes, 15-15.30 o'clock.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Al Zahra
Full name of responsible person
Street address
City
Esfahan
2
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Street address
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of university Medical Sciences, Yazd
Full name of responsible person
Dr. Amir Hooshang Mehrparvar
Street address
Shaheed Sadoughi University of Medical Sciences and Health Services, Shaheed Dr. Ba Honar sq., Yazd, Iran,
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of university Medical Sciences, Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical
Full name of responsible person
Pourandokht Pourkermanian
Position
Student
Other areas of specialty/work
Street address
Buali street, shahid Sadoughi School of Nursing Midwifery, Safaieh, Yazd
City
Yazd
Postal code
Phone
+98 913 212 1532
Fax
Email
p.pourkermanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical
Full name of responsible person
Zohreh Kalani
Position
Masters
Other areas of specialty/work
Street address
Safaieh Street,School of Nursing and Midwifery, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 6671
Fax
Email
kalani-z@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd SHahid Sadoughi University Of Medical Sciences
Full name of responsible person
Pourandokht Pourkermanian
Position
Critical Care Nursing Graduate Student
Other areas of specialty/work
Street address
Bou Ali Street, Safaieh Street,School of Nursing and Midwifery, Yazd
City
Yazd
Postal code
Phone
+98 31 3273 1060
Fax
Email
p.pourkermanian@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)