This is a randomized clinical trial with a control group in 60 patients admitted to internal and surgery ICU of Vali-e-Asr and Ayatollah Mousavi hospitals of Zanjan, Iran. The patients were divided into two groups of 30 people as the intervention and control. Before the experiment began, demographic variables and physical condition of patients were recorded. Touch therapy was conducted in four sessions. Before and after each session of touch therapy, pain and psychological variables (e.g. systolic and diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, Spo2 and heart rhythm and breathing) were recorded in both groups. Data were analyzed by chi-square test, paired and unpaired sample t test, repeated measures ANOVA by statistical software SPSS Ver.21.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061112257N3
Registration date:2015-09-19, 1394/06/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-19, 1394/06/28
Registrant information
Name
Farhad Ramezani-Badr
Name of organization / entity
Zanjan University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 24 3527 9412
Email address
ramazanibadr@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2014-12-06, 1393/09/15
Expected recruitment end date
2015-05-02, 1394/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of therapeutic touch on pain and physiological variables of patients undergoing of mechanical ventilation in intensive care units
Public title
The effect of therapeutic touch on pain and physiological variables of patients undergoing of mechanical ventilation in intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patiants who are under mechanical ventilation in intensive care units of consciousness by GCS> 8; consent of the patient's relatives or legal guardians to participate in the study; patients aged at least 15 years and a maximum of 60 years old; patients who were admitted in ICU for 24 hours; patients predicted to recieve intervention for 4 times; patients who have pain on the results of the survey instrument and score more than 2 times introduced tools to gain. Exclusion criteria: patients with acute neurological disorders or trauma to the head; patients with a history of psychological problems; transferable to other word or fatal; patients suffering from neuromuscular, quadriplegia; patients taking the drug for patients with muscle relaxants; chronic diseases (diabetes, cancer, arthritis Rheumatoid); patients during therapeutic touch their blood pressure more or less than 20% of the base rate and rate of breathing more than 25 times per minute; heart rate more than 20% of the initial state and spo2 10% decline and a lack of coordination with ventilator; patients with acute pain and patiants have acute pain and short term as a result of some invasive treatment methods such as injection and venipuncture and change their positions.
Age
From 15 years old to 60 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vic chancellor for research (science and technology), ethical Committee, Zanjan University of Medica
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
4515789589
Approval date
2014-11-14, 1393/08/23
Ethics committee reference number
ZUMS.REC.1393.154
Health conditions studied
1
Description of health condition studied
Patiants with airway artificial lung
ICD-10 code
J95-99
ICD-10 code description
Other diseases of the respiratory system
Primary outcomes
1
Description
pain
Timepoint
after of every Session
Method of measurement
pain assessment of cpot scale
2
Description
systolic blood pressure
Timepoint
after of every Session
Method of measurement
mmhg , measured with a calibrated monitoring SAADAT company
3
Description
dyastolic blood pressure
Timepoint
after of every Session
Method of measurement
mmhg,measured with a calibrated monitoring SAADAT company
4
Description
mean arterial pressure
Timepoint
after of every Session
Method of measurement
mmhg,measured with a calibrated monitoring SAADAT company
5
Description
pulse rate
Timepoint
after of every Session
Method of measurement
the minutes of number,measured with a calibrated monitoring SAADAT company
6
Description
respiratory rate
Timepoint
after of every Session
Method of measurement
the minutes of number,measured with a calibrated monitoring SAADAT company
7
Description
spo2
Timepoint
after of every Session
Method of measurement
persentage minutesmeasured with a calibrated monitoring SAADAT company
8
Description
cardiac rhythm
Timepoint
after of every Session
Method of measurement
evaluation with 2 nurses
9
Description
raspiratory rhythm
Timepoint
after of every Session
Method of measurement
evaluation with 2 nurses
Secondary outcomes
1
Description
patient death
Timepoint
the patient death during the study
Method of measurement
questionnair
Intervention groups
1
Description
This study is a randomized clinical trial with two groups of control and intervention groups were divided by the blocking method available before of therapeutic thouch, pain and physiologic variables is recorded in intervention group.
Therapeutic touch by touch therapist is performance for patients, the time will be 20-30 minutes and after therapeutic touch, the pain and physiological variables were measured and recorded.
Category
Prevention
2
Description
In the control group, the pain and physiologic variables will be recorded and then shame touch therapy is performanced for 20 -30 minutes. Then the pain and physiological variables assessed and recorded.