This study is a randomized controlled clinical trial. It will be done with purpose of comparing the effects of foot reflexology and foot rub olive oil on asthma control. The project will be implemented after receiving referral letter from the vice chancellor for research of Tabriz university of medical sciences and obtain permission from the ethics committee of Tabriz university of medical sciences and coordination with the officials of specialized and professional pulmonary clinic of Imam Khomeini hospital in Ardabil for patients admitted to this place. The study comprised two intervention groups (a group of foot reflexology and other foot rub olive oil) and a control group. The number of participants in the study determined at least 40 patients by means of this formula: n> sd2 (zα + zβ )2/d2 , (51 patients were selected). It is noteworthy that the standard deviation of the difference between the two groups of studies with variable FEV1, 4.5 is obtained. Participants will be selected through available. The samples will elected from patients who referred to a physician in specialized and professional pulmonary clinic of Imam Khomeini hospital and his medical office in Ardabil. All the adult women should be over 12 years with a diagnosis of asthma. In the first session for each groups of this study the purpose of the study and how to carry out it will be explained and after completion the consent form, the Asthma Control Questionnaire (containing 6 questions, seven points in each question that evaluate asthma control) will be completed By the participants and supervised by a trained researcher assist to avoid bias while completing the questionnaire. All three groups will continue previous asthma medications as directed by their doctors as the routine. Interventions will be done for 10 sessions, twice per week for 15 minutes on each foot by a trained researcher. Interventions will be done in a private room of the clinic. At the end of 10 session intervention and one day after that the questionnaires will be completed again. The implement of Interventions and completion of questionnaires in all three groups will be conducted in parallel and simultaneously. To avoid interference with other group participants, participants in each group will receive the intervention in separate days. The data collected will be compared with each other and asthma control variable will be compared at the beginning and end of the study and between three groups and with the aid of the SPSS 13 will analyze.
1 - Objectives: Comparison of the effects of foot reflexology and foot rub olive oil on asthma control.
Dedicated objectives: Determine and comparison the adequacy of asthma control in foot reflexology group before and after intervention؛ Determine and comparison the adequacy of asthma control in foot rub olive oil group before and after intervention؛ Determine and comparison the adequacy of asthma control in control group at the beginning and end of the study؛ comparison of the adequacy variations of asthma control in the three groups at the beginning and end of the study.
2 - Design: randomized controlled clinical trial.
3 - Setting and conduct: After completion of consent form the Asthma Control Questionnaire will be completed By the participants. All three groups will continue previous asthma medications as directed by their doctors by routine. Interventions will be done for 10 sessions, twice per week for 15 minutes on each foot by a trained researcher. At the end of 10 session intervention and one day after that the questionnaires will be completed again. Intervention implementation and completion of questionnaires in all three groups will be conducted in parallel and simultaneously.
4 - Participants including major eligibility criteria: All the adult women should be over 12 years with a diagnosis of asthma. Inclusion criteria: Women should be over 12 years old؛ Suffering from asthma. Exclusion criteria: Be pregnant؛ Having injury or infection in foot؛ Suffering from cancer or any other blood infections؛ Taking psychiatric drugs؛ Have any fracture in the foot؛ Have leg edema؛ Have DVT؛ Will be hospitalized during the study؛ Suffering from diabetic neuropathy؛ Using of other asthma treatments other than drugs prescribed by doctors.
5 - Intervention: Foot reflexology؛ Foot rub olive oil؛ Control( without intervention).
6 -Main outcome measures variables: Asthma control.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122011825N1
Registration date:2013-05-27, 1392/03/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-27, 1392/03/06
Registrant information
Name
Seemin Dashti
Name of organization / entity
Medical Sciences University Of Tabriz, Faculty Of Nursing And Midwifery of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
s_moghaddasian@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-29, 1392/02/09
Expected recruitment end date
2013-05-14, 1392/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Foot Reflexology and Foot Rub Olive Oil on Asthma Control
Public title
Comparison of the Effect of Foot Massage and Foot Rub Olive Oil on Asthma Control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women should have over 12 years old؛ Suffering from asthma. Exclusion criteria: Be pregnant؛ Having injury or infection in foot ؛ Suffering from cancer or any other blood infections؛ Taking psychiatric drugs؛ Have any fracture in the foot؛ Have leg edema (Increase in diameter of the ankle or forearm with or without pitting)؛ Have DVT (warmth, swelling, edema and pain in leg)؛ Be hospitalized during the study؛ Suffering from diabetic neuropathy (Eliminating the achilles reflex, Decreased pain and temperature sensation in patients with diabetes)؛ Using of other asthma treatments except drugs that prescribed by doctors.
Age
From 12 years old to 100 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee of Tabriz University Of Medical Sciences
Street address
Faculty of Nursing & Midwifery, Shariety South Street,Tabriz, Iran
City
Tabriz
Postal code
Approval date
2013-04-29, 1392/02/09
Ethics committee reference number
1922
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45.8
ICD-10 code description
Mixed asthma
Primary outcomes
1
Description
Asthma Control
Timepoint
Before the intervention, A day after intervention
Method of measurement
Asthma Control Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Foot reflexology: A special massage for the bottom, metatarsus and sides of the foot. It will be done for 10 sessions, twice per week for 15 minutes on each foot by a trained researcher.
Category
Other
2
Description
Olive oil rubbing: Rub olive oil on the metatarsus, sides and bottom of foot. It will be done for 10 sessions, twice per week for 15 minutes on each foot by a trained researcher.
Category
Other
3
Description
Control: Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialty Pulmonary Clinic of Imam Khomeini Hospital in Ardabil; Dr Muhammad Mirzaaqhazadeh Medical