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Effect of concurrent respiratory workout and mobility exercises on pain, anxiety and lung expansion ability in post-operative lung cancer surgery patients with chest tube

Protocol summary

Study aim
determining the effect of concurrent respiratory workout and mobility exercises on pain, anxiety and lung expansion ability in post-operative lung cancer surgery patients with chest tube
Design
a non randomized parallel clinical trial with control group, no blinding
Settings and conduct
motive exercises were performed with left or right arm depending on the side of the chest tube installation. Pain, anxiety, amount of lung secretions and the time of the chest tube removal were measured daily in the control group. Interventions were implemented after surgery in intervention group cases. research was performed at the thoracic surgery ward in Tehran Valiasr hospital; located in Imam Khomeini hospital complex.
Participants/Inclusion and exclusion criteria
inclusion criteria : two chest tubes installed, over 18 years old, completely aware of time, place and who he/she is, not taking Narcotic drugs at least 4 hours before the interventions, no sensory disorder (audio and visual), no substance addiction, not taking anti anxiety drugs, no history of lung diseases and no history of chest tube installation exclusion criteria: severe anxiety due to environmental factors, not being interested to participate, lack of learning ability, addiction
Intervention groups
Respiratory and motive workout were taught to patients of intervention group. These exercises were performed once a day until removal of the chest tube with the presence of the researcher. exercises include deep breathing, pursed lip breathing and motive exercises for arm and shoulder. There was no intervention in the control group and patients received routine care of the hospital including drug therapy, serum therapy and change of the dressings.
Main outcome variables
lung expansion mark on spirometry, measured pain using visual analog scale, measured anxiety using visual analog scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190427043397N1
Registration date: 2019-07-26, 1398/05/04
Registration timing: retrospective

Last update: 2019-07-26, 1398/05/04
Update count: 0
Registration date
2019-07-26, 1398/05/04
Registrant information
Name
Alireza Arman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4000
Email address
alirezaarman20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2018-10-22, 1397/07/30
Scientific title
Effect of concurrent respiratory workout and mobility exercises on pain, anxiety and lung expansion ability in post-operative lung cancer surgery patients with chest tube
Public title
effect of respiratory and mobility exercise on pain, anxiety and lung expansion in post surgery patients with cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
having 2 chest tubes installed over 18 years old completely aware of time, place and who he/she is not taking Narcotic drugs at least 4 hours before the interventions no sensory disorders (audio and visual) no substance addiction not taking anti anxiety drugs no history of lung diseases and no history of chest tube installation
Exclusion criteria:
severe anxiety due to environmental factors not being interested to participate lack of learning ability addiction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 81
Actual sample size reached: 81
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-10-27, 1396/08/05
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4524

Health conditions studied

1

Description of health condition studied
lung cancer
ICD-10 code
C34.90
ICD-10 code description
Malignant neoplasm of unspecified part of unspecified bronchus or lung

Primary outcomes

1

Description
Lung expansion mark on spirometry
Timepoint
Before interventing - after interventin (before removing chest tube)
Method of measurement
Spirometry

2

Description
measured pain using visual analog scale
Timepoint
Everyday until chest tube removal
Method of measurement
Visual Analogue Scale for pain

3

Description
measured anxiety using visual analog scale
Timepoint
Everyday until chest tube removal
Method of measurement
Visual Analogue Scale for anxiety

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: On the first visit with the patients (before surgery and installation of chest tubes) explanations about interventions and the research was given to them, then the informed consent was signed by the patient and demographic information form was filled out by the researcher. The spirometry results was observed and recorded from patient’s file. Before the operation, when patient was present in the ward, and after filling forms mentioned above, instructions for respiratory workout and mobility exercises including diaphragmatic respiration, pursed lip breathing, chest physiotherapy, physical movements for arm and shoulder of the side that chest tube has been installed (whether its left or right) and using incentive spirometer were given to the patient. These instructions were conducted and controlled by the researcher. After the surgery was finished and patient was transferred to the ward, pain and anxiety were measured using visual analog scale (VAS). A checklist was given to the participant which contained all workouts that he/she was meant to do and asked to fill the checklist each time doing the exercises in order to ensure that they perform exercises correctly. The researcher controlled the checklist in order to make sure that no exercise has been missed. Participants were supposed to do the exercises ten times in one hour according to ability and clinical conditions. Therefore, participants performed each exercise that could do until it reaches ten times in one hour and doesn’t make him/her tired. These activities were performed once each day on certain hours (10 AM to 12 MD) with presence of the researcher until chest tube was removed and VAS marks for pain and anxiety were written down.
Category
Prevention

2

Description
Control group: On the first visit with the patients (before surgery and installation of chest tubes) explanations about interventions and the research was given to them, then the informed consent was signed by the patient and demographic information form was filled out by the researcher. The spirometry results was observed and recorded from patient’s file. There were no research related instructions given to the patients of control group. After the surgery was finished and patient was transferred to the ward, pain and anxiety were measured using visual analog scale (VAS). Pain and anxiety were measured daily on certain hours (10 AM to 12 MD) until the tubes were removed. Before the removal of the chest tubes another spirometry test was token from the patients and results were recorded.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital, Imam Khomeini hospital complex
Full name of responsible person
Zahra Rooddehghan
Street address
Dr. Qarib street, End of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2369
Email
zrooddehghan@yahoo.com
Web page address
http://ikhc2.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qods st., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
msahrai@sina.tums.ac.ir
Web page address
http://vcr.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
Alireza Arman
Position
MS student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6105 4000
Fax
Email
alirezaarman20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Arman
Position
MS student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6105 4000
Fax
Email
alirezaarman20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Arman
Position
MS student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6105 4000
Fax
Email
alirezaarman20@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 of financial problems and costs
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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