evaluate the effect of massage therapy on restlessness of patients undergoing mechanical ventilation in ICU
Design
The study will be conducted as a clinical trial in the ICU of Namazi Hospital affiliated to Shiraz University of Medical Sciences from October to December 2017 and on 40 patients in pilot form in order to calculate the final sample size after data collection. Eligible patients enter the study after obtaining informed consent. Sampling is done easily and patients are randomly assigned to groups. The restlessness of patients is calculated by Richmond Agitation-Sedation Scale (RASS).
Settings and conduct
ICU of Namazi Hospitalaffiliated to Shiraz University of Medical Sciences . In the intervention group, therapeutic massages will be performed with the Thai classical method using sweet almond oil. Back, shoulders, deltoid muscles, arms, forearms, palms and fingers and toes, posterior and front parts of thighs, posterior and front parts of shins, back of the legs, abdomen, armpits and neck muscles of the patient will be massaged for 20 minutes in the morning and in the evening. By cutting off the sedatives, the restlessness-sedation score will be evaluated and recorded based on the RASS criteria, 30 minutes before the intervention, 60 and 120 minutes after the intervention.
Participants/Inclusion and exclusion criteria
Restless patients undergoing mechanical ventilation in intensive care units
Intervention groups
therapeutic massages will be performed with the Thai classical method using sweet almond oil.
control group: receives routine care
Main outcome variables
patient's agitat.
need for sedative medications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111224008505N46
Registration date:2018-04-02, 1397/01/13
Registration timing:retrospective
Last update:2018-04-02, 1397/01/13
Update count:0
Registration date
2018-04-02, 1397/01/13
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage therapy on restlessness of patients undergoing mechanical ventilation in ICU
Public title
The effect of massage therapy on restlessness of patients undergoing mechanical ventilation in ICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of the first-degree relatives to participate in the study;
ages 18 and older
intact massage areas
getting permission from the physician
, Glasgow scale score of 5 or higher
lack of addiction to drugs or alcohol
24 hours after hospitalization in the ICU
hemodynamic stability
mechanical ventilation for at least 48 hours
the absence of infectious diseases, hepatitis and known skin problems
lack of dialysis fistula and history of fracture in the last 2 months (to prevent damage to the limbs)
no limitation for body changes (such as acute bleeding , floating chest) or massage (such as severe burns, severe shortness of breath, fever, etc.)
restlessness behavior in the range of +1 to +4 according to the Richmond criterion
Exclusion criteria:
Significant reduction in consciousness
wounds in massage areas
quadriplegia
receiving neuromuscular restrainters
extubation earlier than 48 hours
loss of restlessness after the first intervention,and lack of restlessness for subsequent interventions
patients with known venous thrombosis (for the prevention of embolism)
limb amputation due to sensory impairment
patient for whom the dialysis fistula is inserted or who have fracture
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done easily and patients are randomly assigned to groups. This study is a randomized reverse block method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome of the investigation is that the person under investigation is not aware of any intervention or that the person is intervening.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, 7th floor, Shiity of Medical Sciencraz Universes, Zand Blvd.,
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
IR.SUMS.REC.1396.73
Health conditions studied
1
Description of health condition studied
Agitation
ICD-10 code
R46
ICD-10 code description
symptoms and sings involving appearance and behaviour
Primary outcomes
1
Description
agitation
Timepoint
30 minutes before the intervention, 60 and 120 minutes after the intervention.
Method of measurement
Richmond Agitation-Sedation Scale (RASS)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: therapeutic massages will be performed with the Thai classical method using sweet almond oil. the patient will be massaged for 20 minutes in the morning and in the evening.