the effects of cold therapy and respiratory relaxation technique on pain and anxiety related to chest tube removal in patients who had open heart surgery.
the main aim of this stud is to evaluate the effect of cold application and respiratory relaxation technique on pain and anxiety related to chest tube removal.
detailed aims of the study:
1- Determination and comparison of the pain caused by chest tube removal in patients in four points of time; 20 minutes before chest tube removal, before chest tube removal, immediately and 15 minutes after chest tube removal in all study groups.
2- Determination and comparison of the anxiety caused by chest tube removal in two points of time 20 minutes before chest tube removal, before chest tube removal in all study groups.
Design
randomized control trial
Settings and conduct
randomized control trial
In ICU open heart surgery of Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria were having two test tubes, consciousness, age more than 18, BMI under 35, ability to report pain and anxiety, stable vital signs, not being addicted, the absence of any mental, perceptions, communicating and psycho disorders and willingness to enrol in the study.
exclusion criteria: Administration of analgesic and sedatives 4 hours before the intervention, reactions to Ice unwillingness to continue
Intervention groups
In the control group, no intervention is done.
In the cold application group, the designed ice bag is placed on either side of the chest tube for about 20 minutes.
In respiratory relaxation group patients in a quiet were asked to do the relaxation exercise.
In cold therapy and respiratory relaxation group, both interventions are done at the same time.
Main outcome variables
pain
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170827035918N2
Registration date:2019-05-12, 1398/02/22
Registration timing:retrospective
Last update:2019-05-12, 1398/02/22
Update count:0
Registration date
2019-05-12, 1398/02/22
Registrant information
Name
zahra sajedi monfared
Name of organization / entity
Tehran University of Medical sciences/ Students\' Scientific Research Center (SSRC)
Country
Iran (Islamic Republic of)
Phone
+98 21889891614
Email address
zahrasajedi75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-12-21, 1397/09/30
Trial completion date
2018-12-21, 1397/09/30
Scientific title
the effects of cold therapy and respiratory relaxation technique on pain and anxiety related to chest tube removal in patients who had open heart surgery.
Public title
the effects of cold therapy and respiratory relaxation technique on pain and anxiety related to chest tube removal in patients who had open heart surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
have at least two chest tube.
being more than 18 and consciousness
BMI under 35
ability to report pain and anxiety
have normal vital signs
no drug addiction
without any mental diseases
without any mental , perceptions and communicative problems
willingness to enroll in the study
Exclusion criteria:
Administration of analgesic and sedatives 4 hours before intervention,
reactions to Ice
unwillingness to continue
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
permuted block randomization with a size of four was chosen for this study. firstly, with, drawing lots method, every alphabet of A, B, C, D was assigned to the control group or one of the three intervention groups. Then, two series of 24possible permutations were written separately in different pieces of papers. for example ABCD, ADBC, DCBA,..
written permutations were put in a basket, 30 pieces of papers one by one were drawn out. in this way, the sequence of blocks was determined. after the physician's decisions for removing the chest tubes, the assignments of the patient whose chest tube is going to be removed was determined according to permutation's' order in the block. for example, the first patient's group was determined according to the first permutation in the block.
Blinding (investigator's opinion)
Single blinded
Blinding description
since the researcher prepare the patient before chest tube removal by the physician, the doctor will remain blinded to the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research duty of tehran university of Medical Sciences
Street address
research deputy of Tehran university of medical sciences, Pour Sina St, University St, Enghelab St,
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-01-07, 1396/10/17
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4155
Health conditions studied
1
Description of health condition studied
coronary artery diseases.
ICD-10 code
ICD-10 code description
2
Description of health condition studied
cardiac valve diseases
ICD-10 code
ICD-10 code description
3
Description of health condition studied
open heart surgeries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
theoretically: Unpleasant sensory and emotional experience associated with tissue damage. Practical: The amount of pain related to chest tube removal the patient reports with the pain numeric rating scale.
Timepoint
the pain was assessed in 4 points of time: before the intervention, after intervention before chest tube removal, immediately after chest tube removal, and 15 minutes after chest tube removal.
Method of measurement
numeric rating scale (NRS)
2
Description
anxiety, theoretically: an unpleasant, panic and vague feeling of an unknown source. Practical : The amount of anxiety related to chest tube removal that the patient reports with the numeric rating scale.
Timepoint
Anxiety was assessed in 2 points of time: 20 minutes before chest tube removal, immediately before chest tube removal.
Method of measurement
numeric rating scale
Secondary outcomes
empty
Intervention groups
1
Description
In the control group(group number 1) chest tube is removed according to the ward regulations without any intervention.
Category
Other
2
Description
Intervention group: cold application group (intervention group number 1) while the patient in a semi-fowler position with a pillow under his/her head, the dressing of the chest tube is removed and is washed by the researcher with normal saline, then designed the ice bags which are wrapped by gauze are applied around the centre of chest tub until the skin temperature reach to 13 centigrade degrees (about 20 minutes). An infrared thermometer(without any skin contact) was used for all patients.
Category
Rehabilitation
3
Description
Intervention group: The respiratory relaxation technique( intervention group 2). Firstly respiratory relaxation technique is instructed to the patient and he/she is asked to do it for 15 minutes. In a quiet environment, the patient, with closed eyes, inhale slowly through the nose with two numbers and exhale through semi-closed lips twice slower.
Category
Rehabilitation
4
Description
Intervention group: cold application and respiratory relaxation technique(intervention group number 3 ). 20 minutes before chest tube removal, ice bags are applied for the patient and at the same time, the patient is asked to do respiratory relaxation exercises for 15 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital Complex
Full name of responsible person
Zahra sajedi monfared
Street address
Imam khomeini hospital Complex, Dr. Gharib St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
دکتر محمد علی صحراییان
Street address
research deputy of tehran university, 6th floor, Central Organization of Tehran University of Medical Sciences, Ghods St., keshavarz Blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3614
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
zahra sajedi monfared
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
NO.1079, Floor 7, Tehran University of Medical Sciences buildings, Bahonar Entrance, After Ashrafi Esfahani Exit, West Hakim Expressway
City
tehran
Province
Tehran
Postal code
1473138714
Phone
+98 21 2236 8763
Email
zahrasajedi75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra sajedi monfared
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
NO.1079, Floor 7, Tehran University of Medical Sciences buildings, Bahonar Entrance, After Ashrafi Esfahani Exit, West Hakim Expressway
City
tehran
Province
Tehran
Postal code
1473138714
Phone
+98 21 2236 8763
Email
zahrasajedi75@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra sajedi monfared
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
NO.1079, Floor 7, Tehran University of Medical Sciences buildings, Bahonar Entrance, After Ashrafi Esfahani Exit, West Hakim Expressway
City
tehran
Province
Tehran
Postal code
1473138714
Phone
+98 21 2236 8763
Email
zahrasajedi75@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
because the patient's information is confidential, their information will not be published unless the journal needs them for more analysis.
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
study protocol will be completely and clearly published in a way that other researchers can use them to design and analyze future studies.
study report will also be published in two separate articles, each article explains each primary variable.
When the data will become available and for how long
the time for publishing the data completely depends on the journal protocol.
To whom data/document is available
there is no limitation for accessing data, every student or every therapeutic member can have access to the data.
Under which criteria data/document could be used
because the researcher can not provide free public access, only people who have journal membership, personally or from university or from an organization can have access to the data.
From where data/document is obtainable
the easiest access way is the university server which provides access to different journals.
if the data was not accessible with the server, the applicant can ask for the article by sending an email to the responsible author.
What processes are involved for a request to access data/document
article access completely depends on the journal article, if there is no prohibition about making accessible from the journal, the applicant must follow this process:
send an email to the responsible author and explain the reason for accessing the article, the author information is provided on the journal.
the author will check the request and if the author become sure about not data abusing, only requested part of the article will be send.