Protocol summary

Study aim
Determining the effect of lung rehabilitation through meditation on the respiratory status and depression of patients with chronic obstructive pulmonary disease.
Design
A single-blind clinical trial with a control group and in parallel, randomized by Random Allocation Software
Settings and conduct
The location of the study is Omid Clinic, Babol University of Medical Sciences. In this study, patients will be treated with a meditation method focused on breathing and mind. In this method, patients help to treat their respiratory diseases by focusing on deep and calm breathing. To perform this method, the client sits in a calm and quiet environment. He can place his hands freely on his thigh, knee or side of his body. He is asked to close his eyes. He is asked to breathe slowly and deeply. To focus on breathing, the patient is taught to take air in through the nose and out through the mouth, focusing on the way the air is coming in and out. During the exercise, special meditation music is played for the clients. In this study, considering that after randomization, the patients and the interventionist cannot be blinded; But blinding will be done for the evaluator and analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Age 20 to 60 years 2- According to the GOLD standard, he has a mild or moderate degree of COPD. (Grade 1 or 2) 3- Ability to read and write Non-entry criteria: 1- Suffering from other respiratory diseases 2- Suffering from other chronic diseases in an aggravated and active form 3- Suffering from cognitive disorders Exit criteria: 1- Unwillingness to continue cooperation
Intervention groups
Patients in the intervention group received meditation training in addition to common treatments, but the control group received only common treatments.
Main outcome variables
respiratory status; depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240730062588N1
Registration date: 2024-08-10, 1403/05/20
Registration timing: prospective

Last update: 2024-08-10, 1403/05/20
Update count: 0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Maryam Ghaemi-Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 5677
Email address
m.ghaemi@mubabol.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-10-21, 1403/07/30
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the impact of pulmonary rehabilitation through meditation training on respiratory status and depression in patients with chronic obstructive pulmonary disease.
Public title
Assessing the impact of pulmonary rehabilitation through meditation training in patients with chronic obstructive pulmonary disease.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 60 years According to the GOLD criteria, the patient has a mild or moderate degree of COPD. Ability to read and write
Exclusion criteria:
Suffering from other respiratory diseases Suffering from other chronic diseases in an aggravated and active form Having cognitive disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
To assign the target group to one of the two study groups; The intervention group and the control group (two groups A and B) will use the Block Randomization method with blocks of ten. Participants will be assigned to one of two intervention or control groups according to the block randomization protocol (produced by Random Allocation Software) with a ratio of 1:1, so that the researcher cannot predict which group the next person will be placed in. After selection, each participant is randomly assigned to one of the study groups based on the entry and exit criteria and based on the randomized list. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear who will be assigned to the next group. Based on the sample size of this research, a number of opaque letter envelopes (in order to make the content of the envelopes unclear), preparation and each of the created random sequences are recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the envelopes is glued and placed in a box. At the time of registration, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, considering that after randomization, both the patients and the interventionist cannot be blinded (because the type of intervention is known). On the other hand, the co-measurement of the main outcomes in this study is preclinical and objective. Therefore, blinding cannot be done in the first stage. But blinding will be done for the evaluator and analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee of Babol University of Medical Sciences
Street address
Babol, Ganj Afrooz Street, Babol University of Medical Sciences
City
babol
Province
Mazandaran
Postal code
4717647745
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.MUBABOL.REC.1403.020

Health conditions studied

1

Description of health condition studied
chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Respiratory status
Timepoint
The measurement time is at the beginning of the intervention, and respectively 21, 42 and 56 after the start of its implementation.
Method of measurement
Spirometry, Borg respiratory scale and copd assessment test

Secondary outcomes

1

Description
Depression
Timepoint
The time of measuring this variable is at the beginning of the study and 56 days after its start.
Method of measurement
Beck depression questionnaire

Intervention groups

1

Description
Intervention group: After random allocation, meditation interventions are performed on the intervention group (in addition to common and standard treatments prescribed by a pulmonologist).How to perform meditation:In this study, patients will be treated with a meditation method focused on breathing and mind. In this method, patients help to treat their respiratory diseases by focusing on deep and calm breathing. Also, knowledge and awareness of the body and mental state increases. To perform this method, the client sits in a calm and quiet environment, and things that disturb the client's concentration are kept away from him (such as a mobile phone). The client can sit comfortably on a chair, bed or floor. He can place his hands freely on his thigh, knee or side of his body (so that their body has the minimum possible contraction). He is asked to close his eyes. In the next step, the client focuses on his breathing and is asked to breathe slowly and deeply, and after a few minutes he focuses on his mind. To focus on breathing, the patient is taught to take air in through the nose and out through the mouth and focus on the path of air in and out. In order to breathe deeply and with a long exhalation, each person should perform this action based on his physical ability, but on average, the client should inhale for 4 seconds, then hold the air in his lungs for 7 seconds, and then exhale for 8 seconds. . Then, to focus on the mind, the client is asked to focus on his mind and let go of his thoughts. During the meditation practice, special meditation music (which is wordless) is played for the clients .The training and implementation of the intervention is carried out by one of the colleagues of the present study, who has received the necessary training in the field of meditation implementation. This intervention is taught to patients in medical centers. And they are asked to do this for 15 minutes at least 5 days a week and do this intervention for 6 weeks.
Category
Rehabilitation

2

Description
Control group: The control group will receive only the common treatments prescribed by the pulmonologist and usual nursing care.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Clinic of Babol University of Medical Sciences
Full name of responsible person
Maryam Ghaemi-Amiri
Street address
Babol, Ganj Afrooz St., Babol University of Medical Sciences, Faculty of Medicine, Center for Studies and Development of Medical Education
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5677
Email
m.ghaemi@mubabol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Maryam Ghaemi-Amiri
Street address
Babol, Ganj Afrooz St., Babol University of Medical Sciences, Faculty of Medicine, Center for Studies and Development of Medical Education
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5677
Email
m.ghaemi@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sobhan Rahimi Esbo
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Babol, Ganj Afrooz St., Babol University of Medical Sciences, Faculty of Medicine, Center for Studies and Development of Medical Education
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5677
Email
rrrrsobhan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sobhan Rahimi Esbo
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Babol, Ganj Afrooz St., Babol University of Medical Sciences, Faculty of Medicine, Center for Studies and Development of Medical Education
City
babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5677
Email
rrrrsobhan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sobhan Rahimi Esbo
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Babol, Ganj Afrooz St., Babol University of Medical Sciences, Faculty of Medicine, Center for Studies and Development of Medical Education
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5677
Email
rrrrsobhan@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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