Effects of acupressure on Anxiety and Sleep Quality in Patients with Burn
Design
Blocked randomized, double blind, clinical trial study, single center, controlled placebo, sample size of 72 patients selected in 6 months; allocated to two groups through block randomization method.
Settings and conduct
The present study will be performed in a double-blind manner ( one of the contributors performs the intervention plan and the other partner who does not know about the intervention will collect the data, the person analyzing the findings of the study will also be blind to this grouping) in Valiasr Hospital in Arak.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age15 to 55 years, burns degree of 2 or 3 with 15 to 65 percent burn level, stability of hemodynamic status Exclusion criteria: Burns on the head and face, Unwillingness to cooperate
Intervention groups
In the first day, the base line Anxiety and Sleep Quality of all samples will be checked. Then the samples of the intervention group for three consecutive days receive acupressure in real points (third eye point (Yintang) and Shen men point)) and the samples of the control group receive acupressure in false points. On the fourth day Anxiety and Sleep Quality of the patients will be checked again
Main outcome variables
Anxiety؛ Sleep Quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130424013110N13
Registration date:2021-03-19, 1399/12/29
Registration timing:prospective
Last update:2021-03-19, 1399/12/29
Update count:0
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
Mehdi Harorani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.harorany@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on Anxiety and Sleep Quality in Patients with Burn
Public title
The effect of acupressure in patients with burns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 15 to 55 years old
Burns degree of 2 or 3 with 15 to 65 percent burn level
Stability of hemodynamic status
Exclusion criteria:
Burns on the head and face
Unwillingness to cooperate
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
In this study the randomization will be done using block randomization method. In order to allocate the patients randomly into Intervention and control groups, at first 18 blocks of size 4 with C and T letters (The letters indicate the intervention and control groups) are created. Then the blocks are randomly selected and arranged to obtain a sequential combination of 72 letters. Each letter will be placed in a sealed packet according to the obtained sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
One of the contributors performs the intervention plan and the other partner who does not know about the intervention will collect the data. Finally, after analyzing the questionnaires and entering them in SPSS-16, data analysis will be done. After analyzing data, the group code will be specified. Therefore, the person analyzing the findings of the study will also be blind to this grouping.
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
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij square
City
Arak
Province
Markazi
Postal code
38481-76941
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.ARAKMU.REC.1399.338
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T31
ICD-10 code description
Burns classified according to extent of body surface involved
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before and the fourth day of the intervention
Method of measurement
St. Mary's Hospital Sleep Questionnaire
2
Description
Anxiety
Timepoint
Before and the fourth day of the intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first day, the base line Anxiety and Sleep Quality of all samples will be checked. Then the samples of the intervention group for three consecutive days receive acupressure in real points (third eye point (Yintang) and Shen men point)). On the fourth day Anxiety and Sleep Quality of the patients will be checked again
Category
Treatment - Other
2
Description
Control group: In the first day, the base line Anxiety and Sleep Quality of all samples will be checked. Then the samples of the control group receive acupressure in false points. On the fourth day Anxiety and Sleep Quality of the patients will be checked again
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital Arak
Full name of responsible person
Mehdi Harorani
Street address
Valiasr Hospital, Valieasr Square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
m.harorani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Vice Chancellery For Research And Technology; University campus; Basij square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3503
Email
research@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
Mehdi Harorani
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@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
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available