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The effect of foot reflexology on anxiety in patients undergoing electroconvulsive therapy and complications after it, a clinical trial study

Protocol summary

Summary
The aim of this study is to determine the effect of foot reflexology massage on anxiety, pain and amnesia among psychiatric patients admitted and candidate for electroconvulsive therapy. In clinical trial, 68 electroconvulsive therapy candidate patients who are not in the acute phase of psychosis are divided into two groups, experimental (34 individuals) and control (34 individuals) by Using the random number selected and assigned to two groups of intervention and control. Assigned to random sequence generation method will be performed by a table of random numbers by excel software. For intervention group in workroom, foot massage will be performed three times a week by the researchers and help female researchers in the morning shifts and when will not interfere with the round section (visit time, occupational therapy). Massaging the soles of the feet will be done as three times a week by the researcher and female assistant researcher in the morning shifts and when will not interfere with the round section (visit time, occupational therapy). reflexology mesaage will be done 3 times a week, each session lasts 40 minutes for 1 week, and for each foot massage is done for 20 minutes which includes 10 minutes for foot basic message, and the other 10 minutes of massage is related to anxiety and relaxation areas. Allocated patients in the intervention group, reflexology using with olive oil will be carried out without the using of gloves, and in the control group, Only the patient's feet will be anointed with olive oil. The outcome variables are anxiety, amnesia and pain.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015080623525N2
Registration date: 2016-04-28, 1395/02/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-28, 1395/02/09
Registrant information
Name
Hossein Namdar Areshtanab
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
namdarh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of medical sciences
Expected recruitment start date
2015-12-27, 1394/10/06
Expected recruitment end date
2016-06-09, 1395/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on anxiety in patients undergoing electroconvulsive therapy and complications after it, a clinical trial study
Public title
The effect of foot massage on agitation in patients undergoing electroconvulsive therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: candidated for ECT by a psychiatrist؛ no history of eclectroconvulsive therapy؛ males and females with age of 18 years and over؛ lack of foot problems such as ulceration and scarring؛ Desiring to participate in the study؛ Be alert and aware؛ Lack of drug addiction and non-drug treatment of sleep the night before eclectroconvulsive therapy؛ lack of an underlying medical condition (having diabetes, hypothyroidism, Hypethyroidism, electrolyte disorders, neuromuscular diseases)؛ lack of perceptional disorders and impaired reality testing (hallucinations and delusions)؛ the absence of anxiety disorder؛Inform the doctor about the procedure on the patients؛ getting consent from protector of patient؛ no acute problems vision due to interference by filling out the Visual Analog Scale for Pain (VAS Pain). Exclusion criteria: Patients who for any reason do not have the desire to continue working؛ patients in the acute phase of psychosis (hallucinations and delusions)؛ absence of more than one session in the process of intervention
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Golghasht Ave,
City
Tabriz
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
TBZMED.REC.1394.842

Health conditions studied

1

Description of health condition studied
Anxiety,Amnesia and pain
ICD-10 code
F41.9
ICD-10 code description
Anxiety NOS

Primary outcomes

1

Description
Anxiety
Timepoint
Before and immediately after the intervention
Method of measurement
Spilberger Questionnare

Secondary outcomes

1

Description
َAmnesia
Timepoint
Thirty minutes after electroconvulsive therapy
Method of measurement
Galveston- Orietation-Amnesia-Test

2

Description
Pain
Timepoint
Fifteen minutes after electroconvulsive therapy
Method of measurement
Numeric Pain scale

Intervention groups

1

Description
intervention group: Massaging the soles of the feet will be done as three times a week by the researcher and female assistant researcher in the morning shifts and when will not interfere with the round section (visit time, occupational therapy). reflexology mesaage will be done 3 times a week, each session lats 40 minutes for 1 week, and for each foot massage is done for 20 minutes to 10 minutes for foot basic message, and its 10 minutes of massage areas is related to anxiety and relaxation. Allocated patients in the intervention group, reflexology using with olive oil will be carried out without the using of gloves.
Category
Treatment - Other

2

Description
Only the patient's feet will be anointed with olive oil.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Educational and Treatment Psychiatric center
Full name of responsible person
Hossein Namdar Areshtanab
Street address
Razi Educational and Treatment Psychiatric center, Elgoli road
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
University Ave, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeed Alinezhad machiani
Position
Masters student
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, South Shariati Avenue, Nursing and Midvifery
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
saeed.alinezhad1991@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Namdar Areshtanab
Position
Phd in Nursing Educatin-Assistant Professor
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, South Shariati Avenue,
City
Tabriz
Postal code
5138947977
Phone
+98 41 3470 6770
Fax
+98 41 3479 6969
Email
namdarh@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Namdar Areshtanab
Position
Phd in Nursing Education-Assistant Professor
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, South Shariati Avenue,
City
Tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
namdarh@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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