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The effect of foot reflexology massage on burn specific pain anxiety and sleep condition of patients hospitalized to the burn intensive care unit

Protocol summary

Study aim
Determining The effect of foot reflexology massage on burn specific pain anxiety and sleep condition of patients hospitalized to the burn intensive care unit
Design
52 patients randomly assigned randomly into two groups of 26 massage and control groups based on computer program and Block Randomization.
Settings and conduct
After sampling, foot reflexology massage is performed for the intervention group for 20 minutes in three consecutive days. Then after 15 minutes after dressing, the BSPAS questionnaire is filled in from the third day of hospitalization in the department for 3 days. In the control group, the BSPAS questionnaire was filled out by the researcher immediately before dressing and 15 minutes later. In both groups, the sleep status of the last 24 hours on the third to sixth days before going to dressing is measured based on the hospital sleep questionnaire. The location of the study is Zare Hospital of Sari.
Participants/Inclusion and exclusion criteria
Criteria for entering: 18-65 years old patients , conscious with unintentional, acute burns, moderate and severe burns, and able to communicate with the assessor, 48 hours after admission, no history of mental illness, especially severe anxiety , severe neuropathy, cognitive impairment, and not be addicted to drugs; lack of underlying diseases such as hypothyroidism and illnesses such as rheumatology. not repeatable history of hospitalization, non-burning of the ankle, lack of respiratory distress and no intubation Exit criteria: Intubation of the patient during follow-up, the change in the color of the wound due to infection (according to the positive wound healing), the discharge or death of the patient and the patient's refusal to continue cooperation
Intervention groups
Intervention for the massage group.
Main outcome variables
burn specific pain anxiety and sleep condition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110906007494N27
Registration date: 2018-08-18, 1397/05/27
Registration timing: prospective

Last update: 2018-08-18, 1397/05/27
Update count: 0
Registration date
2018-08-18, 1397/05/27
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on burn specific pain anxiety and sleep condition of patients hospitalized to the burn intensive care unit
Public title
The effect of foot reflexology massage on burn specific pain anxiety and sleep condition of patients hospitalized to the burn intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years old patients, conscious with unintentional, acute burns, moderate and severe burns and able to speak or communicate with the assessor, 48 hours after admission, no history of mental illness, especially severe anxiety, severe neuropathy, such as diabetes, cognitive impairment, and the ability to communicate and hear and not be addicted to drugs; lack of underlying diseases such as hypothyroidism and illnesses such as rheumatology, etc. no repeatable history of hospitalization due to burn, non-burning of the ankle, lack of respiratory distress and no intubation
Exclusion criteria:
Intubation of the patient during follow-up, the change in the color of the wound due to infection (According to the positive wound healing), the discharge or death of the patient and the patient's refusal to continue cooperation
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: 52
Randomization (investigator's opinion)
Randomized
Randomization description
52 patients were randomly assigned into two groups of massage and control with equal number based on computer program and Block Randomization.
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2018-08-05, 1397/05/14
Ethics committee reference number
IR.MAZUMS.REC.97-1679

Health conditions studied

1

Description of health condition studied
Burn specific pain anxiety and sleep condition
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of foot reflexology massage on burn specific pain anxiety and sleep condition
Timepoint
From the third day of admission immediately before massage (for the massage group) and immediately before dressing (for the control group) and 15 minutes later for 3 consecutive days
Method of measurement
BSPAS questionnaire

2

Description
The effect of foot reflexology massage on sleep condition
Timepoint
Determining the sleep status of the last 24 hours on days 3 to 6, before admission to dressing for both groups (test and control)
Method of measurement
SNHSQ questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Foot reflexology massage will be done for 20 minutes (10 minutes per foot) before dressing on days 3 to 5, using baby oil, manufactured by Firuz, with the number (ISO 9001 ISO 14001 OHSAS 18001).
Category
Lifestyle

2

Description
Control group: Do not get any massage.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare Accidents and burns Hospital of Sari
Full name of responsible person
Reza Alinia
Street address
Guibar tree way, Mazandaran University of Medical Sciences
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
reza.alinia1989@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
College Student Research Committee
Street address
Deputy of Research of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1986
Email
Reza.alinia1989@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bagheri Nasami
Position
Ph.D. Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Research Assistant of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3379 5508
Email
Reza.alinia1989@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
Nursing Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, three way Joibar, highway Basij, Imam square, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
anna3043@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
nursing phd
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 1985
Email
Reza.alinia1989@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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