This study was conducted to determine The effect of sensory stimulation on physiologic parameters of critical care patients. The inclution criteria were Eighteen to sixty years of age , 12≥GCS≥9 , Having hemodynamic stability and Exclution criteria were Presence of hearing impairment, skin disorders, psychatric disorder ,life-threatening disease as advanced cancer and renal failer, Create the conditions that needs to emergency Medical or Nursing intervention. Participants were 64 patient hospitalized in intensive care unit that selected using convenience sampling and divided in 2 groups control and intervention. patient's physiologic parameters( systolic blood pressure, diastolic blood pressure, pulse rate and arterial blood oxygen saturation)were measured 10 minutes before intervention and recorded as before intervention physiologic parameters then patient family in intervention group after wearing gown and Slippers and washing hands and rubbing them with antibacterial jel and training about the correct procedure entered to ward and 15 minute Under the supervision of Researcher touched patient and talked with he/her and after 15 minute left the ward. Physiologic parameters were recorded immediately, 10 minutes and 30 minutes after intervention. In control s group Simultaneously without any intervention physiologic parameters were recorded in 0, 27,37 and 57 minute. Intervention was performed twice on day in the morning and afternoon.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110215241N1
Registration date:2013-11-12, 1392/08/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-12, 1392/08/21
Registrant information
Name
Mozhegan Naderi
Name of organization / entity
Faculty of Nursing & Midwifery Isfahan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 75 2422 0090
Email address
mojgannaderi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2012-11-30, 1391/09/10
Expected recruitment end date
2013-10-17, 1392/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sensory stimulation on physiologic parameters of selected hospitals of Isfahan University of Medical Sciences' critical care patients
Public title
The effect of family communication and touch on unconscious patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Eighteen to sixty years of age in patients ; admitted to
ICU >24 h ; 12≥GCS≥9 ; Presence of hemodynamic stability: HR = 60-100 , MBP>65mmHg, o2 sat >90%; Being availabe patient family؛ Pass at least 6 hours from the time of opioid or sedative drugs injection; The patient might be intubated or not. Exclution criteria: Addiction with cigarette, opioide or alchol; Presence of hearing impairment ; Presence of skin disorders; Presence of psychatric disorder; Presence of life-threatening disease as advanced cancer and renal failer; Dopamin, TNG or Dobutamin infusion during intervention; Create the conditions that needs to emergency Medical or Nursing intervention.
Age
From 18 years old to 60 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Science
Street address
Hezarjarib street-Isfahan University of Medical Science
City
Isfahan
Postal code
Approval date
2012-11-27, 1391/09/07
Ethics committee reference number
391317
Health conditions studied
1
Description of health condition studied
decreased level of consciousness
ICD-10 code
R40.2
ICD-10 code description
Coma, unspecified
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention
Method of measurement
Connected to patient hemodynamic manitoring
2
Description
Diastilic blood pressure
Timepoint
10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention
Method of measurement
Connected to patient hemodynamic manitoring
3
Description
Pulse
Timepoint
10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention
Method of measurement
Connected to patient hemodynamic manitoring
4
Description
Oxygen sauration
Timepoint
10 minute before intervention, immediately after intervention, 10 minute after intervention, 30 minute after intervention
Method of measurement
Connected to patient hemodynamic manitoring
Secondary outcomes
1
Description
Family anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory
2
Description
Patient anxiety
Timepoint
Before and after intervention
Method of measurement
Fase anxiety scale
Intervention groups
1
Description
This intervention is performed in three 5 minute section with two 1 minute intervals and is performed twice on day between 10-12 hours in the morning and between 3-5 hours in the afternoon. The families in the intervention group after wearing gown and Slippers and washing hands and rubbing them with antibacterial jel enter the ward and sit on the chair near the bed, call the patient by one’s normal intonation, introduce oneself, hold the patient’s hands, touch the patient gently, talk to the patient about all the measures that had been done for the patient’s
improvement, and wait for 1 min. Then, in the second 5 min of the visit, the visitor again should touch the patient’s hands and face, make the patient familiar with
the time and place, and wait again for 1 min. In the third set of 5 min, the visitor should touch the patient again,
say goodbye, and finally state the time of the next visit.
Category
Other
2
Description
In control group did not perform any intervention exception of routin nursing care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Hojatollah Yousefi
Street address
Sofeh street, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Ayatollah Kashani hospital
Full name of responsible person
Reza Daryabeigi
Street address
Ayatollah Kashani street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Dr. Mir Alimohamad Sabzeghabaii
Street address
Isfahan University of Medical Science -Vice chancellor for Research
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Science
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
Faculty of nursing & Midwifery Isfahan University of Medical Science
Full name of responsible person
Mozhegan Naderi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Hezarjarib street,Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 75 2422 0090
Fax
Email
www.mojgannaderi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery Isfahan University of Medical Science
Full name of responsible person
Dr.Hojatollah Yousefi
Position
PHD of Nursing
Other areas of specialty/work
Street address
Hezarjarib street, Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 31 1792 2944
Fax
Email
www.yousefi@nm.mui.ac.ir
Web page address
www.nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing & Midwifery Isfahan University of Medical Science
Full name of responsible person
Mozhegan Naderi
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Hezarjarib street, Isfahan University of Medical Science
City
Isfahan
Postal code
Phone
+98 75 2422 0090
Fax
-
Email
mojgannaderi@nm.mui.ac.ir
Web page address
www.nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)