The effect of reflexology on post- electroconvulsive thrapy on severity of pain in depressed patients referring to educational-treatmant Razi psychiatric center of Urmia in 2018
The Effect of Reflexology on Post- Electroconvulsive thrapy on severity of Pain in depressed patients
Design
Assignment of patients to the intervention and control groups will be done in a gendered and randomized manner, and a total of 26 people will be in each group.
Settings and conduct
Control of pain intensity in patients referring to Razi Educational-treatment Psychiatric Center, Urmia, Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: age: 18-65 years old; having one of the types of depression that requires the ECT; absence of clear anomalies in the organs; conscious willingness and consent to participate in the study; not being affected by underlying diseases such as diabetes, hypothyroidism, hypoparathyroidism, musculoskeletal disorders; failure to understand perception and disturbance in clear realism; no history for anxiety disorders; no acute vision problems; earn score 3 or higher on a visual scale assessing pain; receive reflexology; no drug addiction or drug intake before the study; receive the drug at least 4 hours before the intervention.
Exit criteria: no collaboration to receive intervention; illness and delirium creation in patient; cancellation of patients for continuation of study; sensitivity to touch.
Intervention groups
In the intervention group, the massage will be performed using odorless olive oil without gloves. After the initial heating of the target member, it will push the reflection points of the head and muscles in the hands and feet (middle finger and thumb) using a special stick and finally use a thumb for the solar network for 2 minutes will be pressed. All steps will be performed within 20 minutes. After 10 minutes, the severity of pain in the intervention group will be measured using the visual instrument of pain.The control group will be given routine care.
Main outcome variables
Severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161116030926N1
Registration date:2018-09-08, 1397/06/17
Registration timing:registered_while_recruiting
Last update:2018-09-08, 1397/06/17
Update count:1
Registration date
2018-09-08, 1397/06/17
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
alilu@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reflexology on post- electroconvulsive thrapy on severity of pain in depressed patients referring to educational-treatmant Razi psychiatric center of Urmia in 2018
Public title
The effect of reflexology on post- electroconvulsive thrapy on severity of pain in depressed patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-65 years old
Having one type of depression (based on documentation of the case and psychiatrist's opinion) that requires ECT
Patient is not in the acute phase of psychosis
Patient with obvious anomalies in the organs
Patient has a willing and informed consent to participate in the study
Patient with underlying diseases such as diabetes, hypothyroidism, hypoparathyroidism, musculoskeletal disorders
Patient at the time of intervention with perceptual impairment and disorder
The patient does not have anxiety disorders according to the diagnosis of the psychiatrist
The patient has no acute visual problems. (Due to interference with the filling of the numerical scale of pain)
Score 3 or higher on the visual scale of pain assessment
No previous massage has been performed
Drug addiction or drug intake before the study
Not using the drug for at least 4 hours before the intervention
Exclusion criteria:
The patient does not have the necessary cooperation to receive the intervention
Intervention causes illness and delusions in the patient
Patient disclaims continuation of the study for any reason
The patient is allergic to the touch and the inability to tolerate massage in the area
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:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to intervention and control groups will be done in a gendered and randomized manner. For this purpose, in two separate and distinct bags, in sex (male or female), the number 14, number one and 14, number two, which are written on the cardboard parts. , Each patient extracts one of the numbers from the bag of his sexual group. Each patient who succeeds in making the number one in the intervention group and each patient who leaves the number two in the control group Will take. At the end of the lottery, fourteen female patients in the intervention group and fourteen female patients in the control group as well as fourteen male patients in the intervention group and fourteen male patients in the control group will be placed.
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
Urmia University of Science & Technology Ethics Committee
Street address
Urmia University of Medical Sciences,
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.UMSU.REC.1397.171
Health conditions studied
1
Description of health condition studied
Severe depression without symptoms of psychosis
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Severity of pain
Timepoint
Measure the severity of pain before the intervention and after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After initial heating, the head will press the reflection points of the head and muscles in the hands and feet (mid-thumb and middle finger) using a reflexology stick (stick) with gentle pressure and without pain, and eventually 2 minutes using the thumb to initially press the solar network at the border between the upper third and middle of the foot of the foot in the area where the foot is folded up when the foot is bent, initially fixed for 2 minutes. And then will be given a rotational massage. The pressure applied is to the extent that the upper third of the fingers of the researcher is white and the patient will feel the pressure, but will not feel pain. All of these steps will be performed within 20,
Category
Treatment - Other
2
Description
Control group: Get routine for pain control
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational-Treatmant Razi Psychiatric Center of Urmia
Full name of responsible person
Maryam Ali ashraf jodat
Street address
Educational-Treatmant Razi Psychiatric Center of Urmُia Salmas Road
City
Urmia
Province
West Azarbaijan
Postal code
5716964457
Phone
+98 44 3272 2930
Fax
+98 44 3365 8921
Email
Alilu@umsu.ac.ir
Web page address
http://razi.umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebi
Street address
Urmia ,Resalat Ave, Mission Center Emergency Department ,University of Science and Technology Dept. of Research and Technology
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Fax
+98 44 3224 0642
Email
Alilu@umsu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Maryam Ali Ashraf Jodat
Position
masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Nazlo, 11th Km Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
+98 44 3365 8921
Email
jodat20@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Leyla Alilu
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwify, Nazlou, 11th Km Sero Road
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
+98 44 3275 4921
Email
Aliluleyla@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Maryam Ali Ashraf Jodat
Position
masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Nazlou, 11th Km Sero Road
City
urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
+98 44 3365 8921
Email
jodat20@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
Not applicable
Informed Consent Form
No - There is not 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