The effect of foot reflexology on the severity of pain, anxiety and sleep quality in patients with burns
Design
In this study, 66 patients with burns with entry criteria are selected. Patients are randomly assigned to control and intervention groups using random numbers. Each group was assigned a code to hide the groups.
Settings and conduct
Department of Burning in Valiasr Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 years
Ability to speak
No damage to the respiratory system
Burns 45% -10% of the total body (TBSA)
Burns Grade 2 and 3
Not Losing Sense of Pain
Non-burning of the floor and on the legs
Ability to communicate
Log in three days after the accident (none of the participants in the acute phase enter the study)
No addiction
Lack of mental illness
Lack of specific underlying disease (such as cancer, fracture, cuts and thyroid disease causing pain and anxiety)
Exit criteria:
Having problems with the legs, including problems with blood flow (confirmed by the cardiologist)
No cuts, burns, fungal infections, varices and warts, corns and any type of numbness in the leg
Use of other complementary and alternative methods during the study
Intervention groups
In the intervention group 3 times a week, one day in the middle for 30 minutes before the reflexology dressing will be done, the reflexology duration for each of the legs will be 15 minutes. Which will include 5 minutes of massage for the general foot and 10 minutes for massaging the solar system, pituitary and pineal gland.
Controls: In the control group, they will receive routine care, and in addition, the intervener will carry out the on-patient intervention on the patient's leg 3 times a week in a day for 30 minutes before changing the gentle touching massage dressing, Duration for each leg is 15 minutes. This is due to the elimination of the effect of the interventional presence and the unification of interventions between the two groups.
Main outcome variables
Severity of pain; Anxiety; Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038211N1
Registration date:2018-02-13, 1396/11/24
Registration timing:registered_while_recruiting
Last update:2018-02-13, 1396/11/24
Update count:0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Fahime Davodabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 7610
Email address
F_davodabady@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-14, 1396/10/24
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on the severity of pain, anxiety and sleep quality in burns patients
Public title
The effect of reflexology on burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 2 and 3 burns that burn 10 to 45% of their body surface.
Exclusion criteria:
There is a vascular, structural and burn problem in the legs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized random numbers were used for randomization in two groups of intervention and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals with entry criteria are divided into two intervention and control groups according to the random numbers table. The people of the intervention group A and the control group B are called. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the grouping of the groups. Data analysis is also done by someone who is unaware of the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
2017-12-17, 1396/09/26
Ethics committee reference number
IR.ARAKMU.REC.1396.232
Health conditions studied
1
Description of health condition studied
BURN
ICD-10 code
T20-T32
ICD-10 code description
Burns and corrosions
Primary outcomes
1
Description
Pain intensity in analgesic visual analog scale pain
Timepoint
One time before the intervention begins on the first day, 5-10 minutes before and after the dressing will be measured in both groups after the start of the intervention for 6 consecutive days.
Method of measurement
analgesic visual analog scale pain
2
Description
Anxiety level with visual analog scale Anxiety
Timepoint
One time before the intervention begins on the first day, 5-10 minutes before and after the dressing will be measured in both groups after the start of the intervention for 6 consecutive days.
Method of measurement
visual analog scale Anxiety
3
Description
Sleep quality with Pittsburgh questionnaire
Timepoint
At the beginning of the study and 6 days after the intervention began
Method of measurement
Pittsburgh questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group 3 times a week, one day in between 30 minutes before the reflexology dressing will be done, the reflexology time for each of the legs will be 15 minutes. Which will include 5 minutes of massage for the general foot and 10 minutes for massaging the solar system, pituitary and pineal .
Category
Treatment - Other
2
Description
Control group: In the control group, they will receive routine care and in addition, the intervener will carry out the treatment on the patient's leg 3 times a week in a day for 30 minutes before changing the soft touch massage dressing. , The duration for each of the legs will be 15 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Fahimeh Davodabady
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
Fahimedavodabady@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@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