Objectives: effects of relaxation methods on Quality of sleep and anxiety of patients with burns
Design
80 of patients with burns will be selected for samples available and by using a randomized complete block will be divided in to intervention and control group.
Settings and conduct
This study is a randomized clinical trial from patients admitted in the ward Burns of Valiasr Hospital in Arak and Sampling is conventional and eligible patients to enter the study will be allocated by lottery to experiment and control groups gradually. For the intervention group initially pre-test questionnaire will be completed. Then educational content will be presented during the one sessions of 30 minutes and the patients this technique will applied With follow-up researcher for 3 days. The curriculum includes providing a quiet environment and education tighten and relax muscles from head to toe or vice versa will be accompanied by deep breathing. The questionnaires after 3 days will be completed for this group, again. Intervention 2: For the control group initially pre-test questionnaire will be completed. While during this period control group only will receive their routine cares and cures, the questionnaires after 3 days will be completed for this group, again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a) age15 to 65 years؛ b) burns degree of 1 to 2 with 15 to 65 percent burn level; c) stability of hemodynamic status. Exclusion criteria: a) Lack of patient cooperation during the intervention for any reason; b) creation dangerous conditions of disease during the intervention.
Intervention groups
Intervention 1: For the intervention group initially pre-test questionnaire will be completed. Then educational content will be presented during the one sessions of 30 minutes and the patients this technique will applied With follow-up researcher for 3 days. The curriculum includes providing a quiet environment and education tighten and relax muscles from head to toe or vice versa will be accompanied by deep breathing. The questionnaires after 3 days will be completed for this group, again. Intervention 2: For the control group initially pre-test questionnaire will be completed. While during this period control group only will receive their routine cares and cures, the questionnaires after 3 days will be completed for this group, again.
Main outcome variables
Anxiety; sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130424013110N4
Registration date:2018-01-21, 1396/11/01
Registration timing:registered_while_recruiting
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
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
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of relaxation on anxiety and Quality of sleep in patients with burns: a randomized clinical trial.
Public title
Effects of relaxation on anxiety and Quality of sleep in patients with burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age15 to 65 years
burns degree of 1 to 3 with 15 to 65 percent burn level
stability of hemodynamic status
Exclusion criteria:
Lack of patient cooperation during the intervention for any reason
creation dangerous conditions of disease during the intervention
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be by using random blocks.
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 Arak University of Medical Sciences
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.ARAKMU.REC.1396.134
Health conditions studied
1
Description of health condition studied
Burns
ICD-10 code
T30.0
ICD-10 code description
Burn of unspecified body region, unspecified degree
2
Description of health condition studied
Aanxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Before and 3 days after the intervention
Method of measurement
Spielberger questionnaire
2
Description
Quality Of Sleep
Timepoint
Before and 3 days after the intervention
Method of measurement
St. Mary's Hospital Sleep Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group initially pre-test questionnaire will be completed. Then educational content will be presented during the one sessions of 30 minutes and the patients this technique will applied with follow-up researcher for 3 days. The curriculum includes providing a quiet environment and education tighten and relax muscles from head to toe or vice versa will be accompanied by deep breathing. The questionnaires after 3 days will be completed for this group, again
Category
N/A
2
Description
Control group: For the control group initially pre-test questionnaire will be completed. While during this period control group only will receive their routine cares and cures, the questionnaires after 3 days will be completed for this group, again.
Category
N/A
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
38149 - 5 - 7558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
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.Mohammad Arjomandzadegan
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38149 - 5 - 7558
Phone
+98 86 3417 3506
Email
m.harorani@yahoo.com
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
38149 - 5 - 7558
Phone
+98 86 3417 3506
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
38149 - 5 - 7558
Phone
+98 86 3417 3506
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
38149 - 5 - 7558
Phone
+98 86 3417 3506
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