Protocol summary
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Study aim
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Therapeutic deep tissue foot massage with jasmine oil in diabetes and hypertensive patients and their effects on blood pressure, heart rate, oxygen saturation, insulin level, temperature, respiration rate, lipid profile.
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Design
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Lottery method, community based, parallel group, double blinded, randomized control trial and 290 patients will be enrolled.
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Settings and conduct
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Study will be conducted at Muhammad Institute of Medical and Allied Sciences Multan after approval from Institutional ethical committee.
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Participants/Inclusion and exclusion criteria
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Incision criteria : Age group of 23-70 years ,Both Genders (Male, Female), Educated and uneducated Diabetic patient, Hypertensive patients,Married and unmarried.Exclusion criteria: Any type of mental disability,Lactating females,Having any type of physical disability,Pregnant females,Any type of major surgery.
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Intervention groups
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The three treatment groups will be treated with therapeutic deep tissue massage with three ways: first group will be treated with jasmine oil manually massage, second group will be treated electric palm massage with jasmine oil massage and third group will be treated with electric palm massager with-out jasmine oil. The deep tissue foot massage will be applied by three ways on the feet of diabetics and hypertensive patients for 20 consecutive days. Each session will be 40 minutes per day. Massage will be applied for 20 minutes on each foot. After 20 days we will compare per and post blood pressure and glucose level in hypertensive and diabetics patients. We will measure objective data heart rate, respiration rate, blood pressure, and glucose level and oxygen saturation.
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Main outcome variables
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Increasing insulin and blood circulation in diabetic patients and will help in reducing mean of arterial pressure (MAP), heart rate, respiratory rate, and increases oxygen saturation in hypertensive patients.
General information
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Reason for update
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We want to update title by simply placing one word ( patients) at the last of line
Plus also updating the position of the person responsible for scientific inquiries
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230103057033N2
Registration date:
2023-02-25, 1401/12/06
Registration timing:
registered_while_recruiting
Last update:
2023-03-17, 1401/12/26
Update count:
2
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Registration date
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2023-02-25, 1401/12/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-11-10, 1401/08/19
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Expected recruitment end date
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2023-04-10, 1402/01/21
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of therapeutic potential of deep tissue foot massage with or without jasmine oil in hypertensive and diabetic patients
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Public title
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Deep tissue foot massage with or without jasmine oil in hypertensive patients and diabetic
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age group of 23-70 years
Diabetic patients
Educated and uneducated
Married and unmarried
Hypertensive patients
Both Genders (Male, Female)
Exclusion criteria:
Any type of mental disability
MI
Pregnant females
Chronic illness related to cardiorespiratory ailments
Any type of major surgery
Having any type of physical disability
Asthma
Angina
History of chest pain
Bronchitis
Lactating females
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Age
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From 23 years old to 70 years old
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Gender
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Both
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Phase
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1
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Groups that have been masked
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- Investigator
- Data analyser
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Sample size
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Target sample size:
290
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization. We will use sealed envelops for lottery method and randomization of participants will be done. Randomization of participants in groups by lottery method and statistical analysis without biasness.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Double blinded study will be done by keeping blind i-e the physiotherapist as Investigator and data analyser
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-20, 1401/07/28
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Ethics committee reference number
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MIMAS/22/IRB/IAK.Durrani
Health conditions studied
1
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Description of health condition studied
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Diabetes Mellitus
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ICD-10 code
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E08
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ICD-10 code description
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Diabetes mellitus due to underlying condition
2
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Description of health condition studied
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Hypertension
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ICD-10 code
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I15.9
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ICD-10 code description
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Secondary hypertension, unspecified
Primary outcomes
1
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Description
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Increase in Blood circulation and insulin secretion in diabetic patients
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Timepoint
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before intervention and 3 weeks after intervention
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Method of measurement
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Blood glucose level by glucometer
2
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Description
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Mean arterial pressure
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Timepoint
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3 weeks
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Method of measurement
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Mercury manometer
3
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Description
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Heart rate
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Timepoint
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3 weeks
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Method of measurement
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Heart rate measuring device
4
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Description
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Oxygen saturation
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Timepoint
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3 weeks
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Method of measurement
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Pulse oximeter
5
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Description
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Respiration rate
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Timepoint
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3 weeks
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Method of measurement
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Manually
Intervention groups
1
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Description
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Control group: Will be treated with jasmine oil.Diabetics and hypertensive patients will receive therapeutic deep tissue foot massage with jasmine oil. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure will be measured by mercury manometer, blood cholesterol (lipid profile) will be measured by lipid measuring device, oxygen saturation by pulse oximeter and temperature by thermometer will be monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients will be measured by BMI scale before massage and after massage will be measured. After 3 weeks all these parameters will be measured again.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 1: Will be treated with electrical massager and jasmine oil. Therapeutic deep tissue foot massage with jasmine oil manually , electric palm massager with jasmine oil, and electric palm massager without jasmine oil will be applied in diabetics and hypertensive patients. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure will be measured by mercury manometer, blood cholesterol (lipid profile) will be measured by lipid measuring device, oxygen saturation by pulse oximeter and temperature by thermometer will be monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients will be measured by BMI scale before massage and after massage will be measured. After 3 weeks all these parameters will be measured again.
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Category
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Treatment - Drugs
3
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Description
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Intervention group 2: Will be treated with electrical massager without jasmine oil.electric palm massager without jasmine oil will be applied in diabetics and hypertensive patients. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure will be measured by mercury manometer, blood cholesterol (lipid profile) will be measured by lipid measuring device, oxygen saturation by pulse oximeter and temperature by thermometer will be monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients will be measured by BMI scale before massage and after massage will be measured. After 3 weeks all these parameters will be measured again.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Student fund
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Grant code / Reference number
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26012023
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Muhammad Institute of Medical and Allied Sciences
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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There is no further formation
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When the data will become available and for how long
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There is no further formation
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To whom data/document is available
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There is no further formation
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Under which criteria data/document could be used
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There is no further formation
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From where data/document is obtainable
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There is no further formation
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What processes are involved for a request to access data/document
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There is no further formation
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Comments
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Please evaluate