Objectives: This study aimed to investigate the effect of tactile stimulation on vital signs and consciousness of traumatic brain injury patients hospitalized in intensive care units.
Design:This study was a quasi-experimental study with pretest- post test design that performed on 60 traumatic brain injury patients hospitalized in intensive care units (with Richmond scores of +2-+2) that underwent mechanical ventilation.
Method:
Intervention was applied with wrist and hand touching for 5 minutes. The GCS and vital signs (heart rate, respiration rate, temperature, systolic and diastolic blood pressure) were measured before and after intervention.
Inclusion criteria:hospitalized with a diagnosis of head trauma; age from 18 to 65 years;no diagnosis of underlying disease such as diabetes (Neuropathy based on patient records); no upper limb disorders;no upper limb disorders; level of consciousness in the range of 5 to 8; no mental problems such as hallucinations or anxiety disorders
Exclusion criteria: no satisfaction to participate; move from Qazvin; a sharp drop in the level of consciousness suddenly.
Intervention: Nurse touches around the patient's wrist and touching his hand slowly. The touching time is 5 minutes.
The main outcome variables: measure the consciousness and vital signs of patients before and after tactile stimulation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062128563N1
Registration date:2017-06-09, 1396/03/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-09, 1396/03/19
Registrant information
Name
Fatemeh Aghaei
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 2809191804286
Email address
f.aghae@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Qazvin University of Medical Sciences
Expected recruitment start date
2016-11-02, 1395/08/12
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tactile stimulation on vital signs and consciousness of traumatic brain injury patients hospitalized in intensive care units
Public title
The effect of tactile stimulation on vital signs and consciousness of traumatic brain injury patients hospitalized in intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patient is hospitalized with a diagnosis of head trauma; Patient age ranged from 18 to 65 years; diagnosis of underlying disease such as diabetes (neuropathy due to possible based on patient records) is not; upper limb disorders in no sense; upper limb disorders in no sense; The patient's level of consciousness is in the range of 5 to 8; patient mental problems such as hallucinations or have anxiety disorders
Exclusion criteria:patient dissatisfaction partners to continue to participate in the study; sample transport to other centers outside the city of Qazvin; a sharp drop in the level of consciousness suddenly; patients in both groups during the study and control at the same time patient care plans similar companies such as massage and relaxation techniques
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using two-color balls in white (for control) and red (for intervention) for randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin - shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Postal code
59811-34197
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.QUMS.REC.1395.169
Health conditions studied
1
Description of health condition studied
head trauma Patients
ICD-10 code
S00-S09
ICD-10 code description
Injuries to the head
Primary outcomes
1
Description
level of consciousness
Timepoint
Before and after the intervention
Method of measurement
Using the Glasgow Coma Scale
Secondary outcomes
1
Description
vital sign
Timepoint
Before and after the intervention
Method of measurement
Using the monitoring -barometer-digital thermometer
Intervention groups
1
Description
Intervention group: Intervention in this case would be The intervention group, touch the wrist and the whole hand For 5 minutes, In the morning and evening
for control group, all the routine cares will be delivered. Intervention will proceed in the first to the fifth day of hospitalization.Thus the 5 minutes before the intervention, researcher will be measured patient's vital signs, including blood pressure and pulse rate and respiration, body temperature and measure and record the patient's level of consciousness. Nurse fingers then gently placed around the patient's wrist without any Pressure.Time touching the patient's wrist and touch the whole hand is 5 minutes. Immediately after the intervention Again, vital signs and level of consciousness will be measured and recorded.This interference in the morning(11 am) and evening(17pm) for patients in this study was done.
Category
Treatment - Devices
2
Description
Control group:the control group, vital signs twice a day (at 11 am and 5 evenings) with an interval of 5 minutes, while rejecting any intervention on the patient.