Protocol summary

Study aim
To compare the effects of Jacobson’s and Laura Mitchell’s technique to improve the quality of life and sleep in COPD patients.
Design
Two parallel group , single blinded, randomized clinical trial with post treatment evaluation.
Settings and conduct
Gulab Devi Chest Hospital Lahore.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1.Age between 20-45 years 2.COPD of 6 months or longer 3.Patients with stage 3 or 4 (According to GOLD system) 4.Patients having cognitive ability. Exclusion criteria 1.Acute asthmatic attack 2.Repeated cough 3.Active hemoptysis 4.Cardiac instability
Intervention groups
Laura Mitchell Relaxation Technique Jacobson’s Progressive Relaxation Technique
Main outcome variables
Pittsburgh Sleep Quality Index and St. George’s Respiratory Questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191117045462N5
Registration date: 2021-08-17, 1400/05/26
Registration timing: prospective

Last update: 2021-08-17, 1400/05/26
Update count: 0
Registration date
2021-08-17, 1400/05/26
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-31, 1400/06/09
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Jacobson’s Progressive Relaxation Technique and Laura Mitchell’s Relaxation Technique in improving quality of life and sleep in COPD Patients.
Public title
Comparison of Jacobson’s Progressive Relaxation Technique and Laura Mitchell’s Relaxation Technique in improving quality of life and sleep in COPD Patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-45 years COPD of 6 months or longer Patients with stage 3 or 4 (According to GOLD system) Patients having cognitive ability.
Exclusion criteria:
Acute asthmatic attack Repeated cough Active hemoptysis Cardiac instability
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Patient will be blind.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated to groups by simple randomization process by opaque sealed envelope.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath , Lahore.
City
Lahore
Postal code
54000
Approval date
2021-03-19, 1399/12/29
Ethics committee reference number
RCRS-RE-MSPT-CPPT/Spring 20/052

Health conditions studied

1

Description of health condition studied
Severe COPD patients
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Sleep
Timepoint
5 sessions per week for 2 weeks and post treatment evaluation will be done after 2 weeks
Method of measurement
Pittsburgh Sleep Quality Index Questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
5 sessions per week for 2 weeks and post treatment evaluation will be done after 2 weeks
Method of measurement
Quality of life via St. George’s Respiratory Questionnaire

Intervention groups

1

Description
Intervention Group: Laura Mitchell Relaxation Technique
Category
Treatment - Other

2

Description
Intervention group: Jacobson’s Progressive Relaxation Technique
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Hajira Mujahid
Street address
28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath , Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
hajiramujahid15@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah College of Rehabilitation and Allied Health Sciences
Full name of responsible person
Wajeeha Zia
Street address
28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath , Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educationall
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah College of Rehabilitation and Allied Health Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Riphah College of Rehabilitation and Allied Health Sciences
Full name of responsible person
Hajira Mujahid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath , Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
hajiramujahid15@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah College of Rehabilitation and Allied Health Sciences
Full name of responsible person
Wajeeha Zia
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath , Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah College of Rehabilitation and Allied Health Sciences
Full name of responsible person
Hajira Mujahid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
28-M, Quaid-e-Azam, Industrial Estate Kot Lakhpath , Lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
hajiramujahid15@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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