Determining the effect of dyang sensory stimulation on pain and restlessness of patients admitted to ICU wards of Bahonar hospital in Kerman, 1398-1397
Design
This study was performed in 60 patients admitted to Bahonar Hospital in a simple randomized double blind measure of pain and restlessness in patients with thirty patients in the intervention group and thirty patients in the control group
Settings and conduct
This study is a randomized, double blind clinical trial performed on patients admitted to intensive care units of Bahonar Hospital in Kerman. Sensory stimulation based on Dyang's table includes visual, auditory, olfactory, tactile and motor stimulation. Patients in the intervention group receive sensory stimulation twice a day for six days. The control group is under routine care. In the intervention group, the patient's pain was measured by the BPS criteria and restlessness with the Rass criterion before and 15 minutes after sensory stimulation by someone other than the researcher.In this study, patients beacuse of low conscious and evaluator did not know about control group or intervention group
Participants/Inclusion and exclusion criteria
Age between 18-60 year- There arenot numerous fracture in limbs and thorax -The level of conscious is between 5 -8
Intervention groups
Patients admitted in ICU wards of Bahonar Hospital in Kerman
Main outcome variables
pain and restlessness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N21
Registration date:2019-11-02, 1398/08/11
Registration timing:retrospective
Last update:2019-11-02, 1398/08/11
Update count:0
Registration date
2019-11-02, 1398/08/11
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-03-21, 1398/01/01
Actual recruitment end date
2019-08-18, 1398/05/27
Trial completion date
2019-08-18, 1398/05/27
Scientific title
The effect of dyang sensory stimulation on the pain and restlessness of patients admitted to intensive care units
Public title
The effect of sensory stimulation on the pain and restlessness of patients admitted to intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-60 years old
There arenot numerous fracture in limbs and thorax
The level of conscious is between 5 -8
Exclusion criteria:
Death
Starting a continuous infusion of sedative medicine for the patient
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
4
Randomization (investigator's opinion)
Randomized
Randomization description
60 patients are selected for entry criteria. Subsequently, according to the random block method, people are divided into two groups of 30 patients، intervention group and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researcher colleague do not aware of the type of group. Patients do not aware of their type of group because of decreased level of consciousness. The researcher colleague who measure pain and restlessness in both groups do not aware whether the Patient receive sensory stimulation (intervention group) or not (control group).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali Blv, Central Organization of the Central Organization of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.RUMS.REC.1397.260
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
2
Description of health condition studied
restlessness
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Sensory stimulation of Dyang
Timepoint
For maximum of thirty minutes
Method of measurement
Sensory stimulation table Dyang
Secondary outcomes
1
Description
pain
Timepoint
Sensory stimulation table Dyang
Method of measurement
Behavioral Pain scale
2
Description
restless
Timepoint
Before and fifteen minutes after diang of sensory stimulation
Method of measurement
Richmond Agitation-Sedation Scale
Intervention groups
1
Description
In the intervention gourp The sensory stimuli of Dyang are exactly based on the sensory arrangement in the Dyang's table, which includes visual, auditory, olfactory, tactile and motor stimulation. Stimulation of vision by turning off the flashlight in front of the patient's eyes for 2 seconds, stimulating the hearing by telling the patient's name and time, place and day near the patient's ears three times, stimulating the smell of cotton be soaked with rose water in the patient's nose for 5 seconds , Stimulation of the touch with hand pressure, massage and rubbing the cotton and gas in to the skin, first on one side of the body and then on the other side, and stimulating the movement by moving the joints of the hands, feet, hands, arms and shoulders by bending and straightening up and down. Alternate hands This intervention continue 6 days for every patient,two times a day and one hour for every time.
Category
Treatment - Devices
2
Description
Control group: In the control group, do not any intervention. routine care is performed
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Shahid Bahonar Hospital
Full name of responsible person
Khadije Mohammady
Street address
Gharani St. Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospitalresearch@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Shamsizade Ali
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.Mirzaei@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ravari
Position
Nursing PH.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
ravary4776@yahoo.com
Web page address
https://rums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ravari
Position
Nursing PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam Ali Bulvarde-central institute
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
ravary4776@yahoo.com
Web page address
https://rums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam Ali Bolv., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir
Web page address
https://rums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available