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Effect of Iranian massage on the physical symptoms of post intensive care syndrome (PICS) in patients discharged from the respiratory intensive care unit

Protocol summary

Study aim
Effect of Iranian massage on the physical symptoms of post intensive care syndrome(PICS) in patients discharged from the respiratory intensive care unit
Design
Clinical trial with control group, single blind, randomized, on 74 patients. For randomization, Ede method with SPSS software will be used.
Settings and conduct
The place of the intervention (Iranian Delak massage) will be the respiratory department of Imam Khomeini, Sina and Shariati hospitals. One-way blinding will be applied to the statistical analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. age between 18 and 65 years 2 .has been admitted for at least one week in intensive respiratory care unit and has received common treatment for intensive care units. 3. Intubation during ICU stay. 4.during the ICU stay , diagnosing one types of respiratory diseases such as COPD , corona ,ARDS ,pneumonia ,cystic fibrosis and asthma by the practitioner. 5. show at least two signs of physical symptoms of post intensive care syndrome (pain ,muscle weakness ,impairment in daily activities ,dyspnea). Exclusion criteria: 1. Suffering from an underlying disease of the neuromuscular system (neurological symptoms in the limbs, suffering from diabetic neuropathy and a history of lumbar and cervical disc herniation) 2. Epilepsy 3. Pregnancy 4. Suffering from hemophilia 5. History of diagnosed psychological diseases
Intervention groups
The intervention in the Iranian Dalk massage test group is of the talent Dalk type, which takes place in four consecutive sessions daily for thirty minutes each time. In the control group, routine ward care will be performed.
Main outcome variables
Pain, muscle weakness, ability to perform daily activities independently, shortness of breath

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191027045257N2
Registration date: 2022-10-08, 1401/07/16
Registration timing: registered_while_recruiting

Last update: 2022-10-08, 1401/07/16
Update count: 0
Registration date
2022-10-08, 1401/07/16
Registrant information
Name
Pegah Matourypour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4126
Email address
matourypour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Iranian massage on the physical symptoms of post intensive care syndrome (PICS) in patients discharged from the respiratory intensive care unit
Public title
The effect of massage on physical symptoms after discharge from the intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age between 18 to 65 years 2. Has been hospitalized in the respiratory intensive care unit for at least one week and has received the usual treatments in the intensive care unit. 3. Intubation of the patient during ICU hospitalization 4.The diagnosis of one of the types of respiratory diseases such as COPD, improved covid19 patients, ARDS, pneumonia, cystic fibrosis and asthma is made by the treating physician. 5. Show at least two signs of the physical symptoms of the post intensive care syndrome (pain, muscle weakness, disturbance in daily activities of life, dyspnea)
Exclusion criteria:
1. Underlying disease of the musculoskeletal system (neurological symptoms in the limbs, diabetic neuropathy and a history of hernia and lumbar and cervical disc) Epilepsy pregnancy hemophilia History of diagnosed mental illness
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
The present study will be a two-group randomized clinical trial in which the effect of Iranian Dalk massage on the physical symptoms of the post intensive care syndrome will be investigated. 74 patients who were admitted to the respiratory intensive care unit (37 in the control group, 37 in the intervention group) and were transferred to the respiratory ward, who had at least two signs of physical symptoms of the post intensive care syndrome and based on Inclusion criteria will be included in the study. Random allocation will be done, by writing "control group" and "Intervention Group" on cards and we request patients who has inclusion criteria to pick one card from dish to know in which group should go (cards do not replace in dish).
Blinding (investigator's opinion)
Single blinded
Blinding description
By coding the intervention and control group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in the Research Institute of the Faculty of Nursing and Midwifery and the Faculty o
Street address
Tohid sq, Dr Mirkhani st
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-01-13, 1400/10/23
Ethics committee reference number
IR.TUMS.FNM.REC.1400.180

Health conditions studied

1

Description of health condition studied
respiratory diseases
ICD-10 code
R06. 03
ICD-10 code description
R06. 03

Primary outcomes

1

Description
Pain, muscle weakness, ability to perform activity of daily living
Timepoint
Before the intervention, immediately after the intervention and one month after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Dyspnea
Timepoint
Before the intervention, immediately after the intervention, one month after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Doing Iranian Dalk massage for 30 minutes for four consecutive days , in addition to the routine care of the ward.
Category
Prevention

2

Description
Control group: They will receive the usual care of the ward.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Seyyed Ali menshadi
Street address
Dr Gharib st, Keshavarz Blvd, Tehran town
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir/

2

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Ahmadreza jamshidi
Street address
Shariati Hospital, Jalal Al Ahmad Street, North Kargar St., Tehran town
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/

3

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohammad taleb pour
Street address
Sina hospital, Imam Khomeini St., Hassan Abad Square, Tehran town
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6739 5656
Email
hosp_sina@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of research and technology, Tehran University of Medical Sciences
Street address
6th floor of Research and Technology Vice-Chancellor,, Central Organization of the University, corner of Quds St,Keshavarz Blvd. Tehran Town
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
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
Pegah Matouypour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (East Nusrat), Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
matourypour@yahoo.com
Web page address
http://fnm.tums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pegah Matoury
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat), Tehran Town
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4315
Fax
Email
matourypour@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyyede zahra sajjadian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St. (East Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
zahrasajjadian76@gmail.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
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