To determine the effects of diaphragmatic and paced breathing on pulmonary function , hot flashes and postmenopausal syndrome in women.
Design
44 participants will be recruited. Two parallel groups, double blinded, randomized clinical trial with pre and post assessment.
Settings and conduct
This study will be conducted in gynecology department at Mussarat Razzaque hospital 196 G.T road baghbanpura Lahore. Participants and outcome assessor will be blinded.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA
Menopausal women having symptoms
Hot Flashes during menopause
Not currently taking hormonal replacement therapy, a psychoactive medication, and not using complementary therapy for menopausal symptoms.
EXCLUSION CRITERIA
Had hormonal replacement therapy
Having any cardiac and lung diseases will be excluded
If they had history of breast cancer , mayocardial infarction and pulmonary embolism.
Intervention groups
Group A: will be treated by Diaphragmatic Breathing
Group B: will be treated by Paced Breathing
Main outcome variables
Menopause rating scale (MRS), Hot flash-related daily interference scale,
Pulmonary function changes by using a portable spirometer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191117045462N11
Registration date:2024-01-22, 1402/11/02
Registration timing:registered_while_recruiting
Last update:2024-01-22, 1402/11/02
Update count:0
Registration date
2024-01-22, 1402/11/02
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
2023-12-10, 1402/09/19
Expected recruitment end date
2024-04-10, 1403/01/22
Actual recruitment start date
2023-12-10, 1402/09/19
Actual recruitment end date
2024-04-10, 1403/01/22
Trial completion date
2024-06-10, 1403/03/21
Scientific title
COMPARATIVE EFFECTS OF DIAPHRAGMATIC BREATHING AND PACED BREATHING ON PULMONARY FUNCTION, HOT FLASHES AND POST-MENOPAUSAL SYNDROME IN WOMEN
Public title
COMPARATIVE EFFECTS OF DIAPHRAGMATIC BREATHING AND PACED BREATHING ON PULMONARY FUNCTION, HOT FLASHES AND POST-MENOPAUSAL SYNDROME IN WOMEN
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women having symptoms
Hot Flashes during menopause
Not currently taking hormonal replacement therapy, a psychoactive medication, and not using complementary therapy for menopausal symptoms
Exclusion criteria:
Had hormonal replacement therapy
Having any cardiac and lung diseases will be excluded
If they had history of breast cancer , mayocardial infarction and pulmonary embolism
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group through Random Sampling by lottery method. Labeled as group A and group B
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
Riphah college of rehabilitation & Allied Health Sciences
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
Intervention group A: Diaphragmatic Breathing group : Group A will be treated with diaphragmatic breathing cycles (6breaths/min), including 5s of inhalation and 5s exhalation, for twice a day and 15 minutes per day for 3 weeks .
Category
Treatment - Other
2
Description
Intervention group B: Paced Breathing Group :Group B will be treated by Paced Breathing slowly count for four while inhaling through the nose and feel the abdomen rise, hold breath for 1sec and slowly exhaling through lips repeat exercise 6 to 8 minutes per minutes twice a day for 3 weeks.
Category
Treatment - Other
3
Description
Baseline intervention: Lifestyle intervention adviceEach patient in both groups will instructed to follow lifestyle intervention advice. The advice included avoiding eating or drinking before going to bed , and increasing consumption of a whole diet rich in fruit, vegetables, carbohydrates, and legumes . Moreover, advice included preparing for sleep by mentally calming down at night and avoiding afternoon naps, making sure the bedroom was comfortable, warm, calm, and dark , avoiding sleeping near a light source , going to bed when feeling tired, getting up when unable to sleep, and rising at the same time every morning.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah college of rehabilitation & Allied Health Sciences
Full name of responsible person
Riphah college of rehabilitation & Allied Health Sciences
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
gullnazyousaf334@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah international university
Full name of responsible person
wajeeha
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Grant name
Educational
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Riphah international university
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 international university
Full name of responsible person
Gullnaz Yousaf
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 42 35126110
Email
wajeeha_z@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah international university
Full name of responsible person
wajeeha
Position
Senior lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, 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 international university
Full name of responsible person
Gullnaz Yousaf
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
13-14-C-civic center, township near Hamdard Chowk, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
gullnazyousaf334@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
N/A
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