Determination and Comparison of the Effect of Reflexology and Stroke Massages on Symptoms and Ventilation Index of Patients with Bronchial Asthma
Design
Randomized Clinical trial with a parallel control, supportive group with blinding
Settings and conduct
Study location: Shahid Mofateh Clinic and Health Center, Yasuj
The samples are divided into three groups of control, reflexology, and stroke massage. All patients receive routine asthma treatment during the study, and massage therapy is performed along the routine treatment. Patients suffer from mild to moderate asthma. The study last one month including one session a week for four weeks. In both intervention groups, variables are measured before and after the intervention. The effect of massage on the symptoms of asthma during the one-month period is evaluated before the beginning of the intervention in the first session and after the end of the study in all three groups. This is a single-blind study and the participants are not aware of their group.
Participants/Inclusion and exclusion criteria
Inclusion criteria;Mild to moderate asthma, forced expiratory volume in 1 second (FEV1) >60% or <95%, no hematologic disease such as hemophilia, no other treatments such as relaxation and psychotherapy.
Exclusion criteria
Exacerbation and persistence of the disease and acute asthma attack.
Intervention groups
In this group FEV1 and respiratory rate are measured in four sessions (once a week) before and after foot massage and stroke massage. The signs are checked at the beginning and the end of the intervention. The foot massage is performed for 15 minutes and stroke massage for 10 minutes. In the control group, only the parameters are measured.
Main outcome variables
Daily Cough;
Forced expiratory volume in 1 second;
Level of oxygen saturation in blood;
Respiratory rate;
Night cough.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180902040924N1
Registration date:2019-01-29, 1397/11/09
Registration timing:registered_while_recruiting
Last update:2019-01-29, 1397/11/09
Update count:0
Registration date
2019-01-29, 1397/11/09
Registrant information
Name
Elham Sarikhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4446 7175
Email address
elham.sarikhani@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of reflexology massage and stroke on symptoms and ventilatory parameters in patients with bronchial asthma
Public title
Comparison of the effects of reflexology massage and stroke on patients with bronchial asthma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years;
No cognitive, hearing, and visual impairment;
Ability and willingness to participate in the study; no use of drugs or psychotropic substances;
Definite diagnosis of mild to moderate sustained asthma according to the physician’s opinion for more than 1 year;
Forced expiratory volume in 1 second (FEV1) >60% or <95%;
No hematologic disease such as hemophilia, reduced platelet, and deep vein thrombosis (DVT);
No other treatments such as relaxation and psychotherapy.
Exclusion criteria:
Unwillingness to continue participating in the study
New disease
The progression of the disease to a severe and persistent
Death
If the patient has an acute asthma attack.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly allocated in two groups of intervention and two group control, and a code are assigned for each participant.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
does not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj, Shahid Motahari Blvd, Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
00
Approval date
2018-08-11, 1397/05/20
Ethics committee reference number
IR.YUMS.REC.1397.066
Health conditions studied
1
Description of health condition studied
Bronchial asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
The volume of air that is exerted by pressure in the first second from the lungs is measured as a percentage, the breathing rate per minute,
Timepoint
Each session is measured before and after intervention.
Method of measurement
Spirometer
2
Description
Respiratory rate in one minute
Timepoint
Before and after intervention in each session
Method of measurement
Clinical examination
3
Description
Oxygen saturation
Timepoint
Before and after intervention in each session
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
Daily cough (more than twice a week)
Timepoint
Before the intervention and at the end of the intervention (in the final session)
Method of measurement
Questionnaire according to severity classification of asthma
2
Description
Overnight cough 3-4 times a month, 1 time or more per week
Timepoint
Before the intervention and at the end of the intervention (in the final session)
Method of measurement
Questionnaire according to severity classification of asthma
3
Description
Shortness of breath 1 times per year due to shortness of breath / twice and more admitted due to shortness of breath,
Timepoint
Before the intervention and at the end of the intervention (in the final session)
Method of measurement
Questionnaire according to severity classification of asthma
4
Description
Restricted activity
Timepoint
The beginning of the intervention before the intervention and the end of the intervention in the final session of the study
Method of measurement
Questionnaire according to severity classification of asthma
Intervention groups
1
Description
Reflexology massageThe patients in this group are selected according to the inclusion criteria after completing the questionnaire, and their FEV1 and respiratory rate are measured in four sessions (once a week) before and after reflexlogy massage . The signs are checked at the beginning and the end of the intervention. The reflexology massage is performed for 15 minutes.
Category
Rehabilitation
2
Description
stroke massage;The patients in this group are selected according to the inclusion criteria after completing the questionnaire, and their FEV1 and respiratory rate are measured in four sessions (once a week) before and after stroke massage . The signs are checked at the beginning and the end of the intervention. The reflexology massage is performed for 10 minutes.
Category
Rehabilitation
3
Description
Control group: Do not get an intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh Clinic
Full name of responsible person
Behrozi Shokroallah
Street address
Shahid Montazeri Ave
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
0
Phone
+98 74 3322 8212
Email
sarikhani6491@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Shahid Damideh Health Center
Full name of responsible person
Moradi Mohsen
Street address
Imam Hossein Square, Yasuj University of Medical Sciences, Yasuj,
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
0
Phone
+98 74 3334 6078
Email
sarikhani6491@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Ali Mousavi Zadeh
Street address
Motahari Ave,Yasuj University of Medical
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
0
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
mousavizadeh@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Elham Sarikhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO, 18, Kosar Ave
City
Safashahr
Province
Fars
Postal code
73961
Phone
+98 71 4446 7175
Email
elhamsarikhani@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shahla Najafi
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Motahhari Blvd, Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
0
Phone
+98 987433230327
Email
najafi.shahla@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Elham Sarikhani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO.18،Kosar street
City
Safashahr
Province
Fars
Postal code
7396176491
Phone
+98 71 4446 7175
Email
elham.sarikhani@yums.ac.ir
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