The effect of foot reflexology massage on the duration of maximal consciousness and weaning of Ventilator in patients with brain tumor after craniotomy surgery
Determining the effect of foot reflexology massage on the duration of maximal consciousness and weaning of Ventilator in patients with brain tumor after craniotomy surgery
Design
In this randomized clinical trial, patients will be randomly assigned to two groups of 30 people.
Settings and conduct
This study will be performed in the intensive care unit of Shahid Beheshti Hospital in Kashan. 60 patients are randomly divided into two groups of intervention (foot reflexology) and control. Outcomes are assessed 1 to 7 days after surgery. Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having the consent to participate in the study, Age 18–65 years, The patient's level of consciousness should be between 5 and 7 according to the Glasgow Coma Criterion, Patients underwent craniotomy surgery and hospitalization in the intensive care unit, The patient is connected to a ventilator.
Exclusion criteria: Patients who need a long-term intubation at the discretion of a neurosurgeon
Intervention groups
In the intervention group, foot reflexology will be performed for 15 minutes for each foot and twice a day for a week.
The control group will not receive any intervention for a week and will receive routine care such as medication.
Main outcome variables
Achieve consciousness and weaning of Ventilator
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N47
Registration date:2020-08-19, 1399/05/29
Registration timing:registered_while_recruiting
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on the duration of maximal consciousness and weaning of Ventilator in patients with brain tumor after craniotomy surgery
Public title
The effect of foot reflexology massage on the duration of maximal consciousness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the consent to participate in the study
Age 18–65 years
The patient's level of consciousness should be between 5 and 7 according to the Glasgow Coma Criterion
Patients underwent craniotomy surgery and hospitalization in the intensive care unit.
The patient is connected to a ventilator.
Exclusion criteria:
Patients who need a long-term intubation at the discretion of a neurosurgeon
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
Random allocation in two groups of intervention and control will be simple randomization. Randomization is carried out by creating a random sequence of numbers using a randomizer tool (https://www.randomizer.org).
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
Ethics committee of Kashan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-06-27, 1399/04/07
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.026
Health conditions studied
1
Description of health condition studied
Reflexology
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Achieve consciousness
Timepoint
Before the intervention and the first to seventh days after surgery
Method of measurement
The Glasgow Coma Scale
Secondary outcomes
1
Description
Weaning of ventilator
Timepoint
Before the intervention and the first to seventh days after surgery
Method of measurement
Researcher checklist
Intervention groups
1
Description
Intervention group: In addition to routine care (medication), foot reflexology therapy in three stages including preparation, warm-up and stimulation and massage techniques will be performed for 30 minutes (15 minutes for each foot) and twice a day, morning and evening for a week by the researcher.
Category
Treatment - Other
2
Description
Control group: Only routine care including medication will be performed for patients by health personnel. No intervention will be performed for them during the research.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive care unit of Kashan Shahid Beheshti Hospital
Full name of responsible person
Neda Mirbagher
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Vice Chancellor of Research & Technology, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
banafshe_h@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Monir Ezadinezhad
Position
Master's degree student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
izadinezhad_m@yahoo.com
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