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Comparative effects of therapeutic deep tissue foot massage with or without jasmine oil in diabetic and hypertensive patients

Protocol summary

Study aim
Therapeutic deep tissue foot message 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 .
Design
Lottery method, community bases,parallel group, Double blinded,Randomized control trial.there were 393 patients were enrolled.
Settings and conduct
Study was conducted at Muhammad Institute of Medical and Allied Sciences Multan after approval from Institutional ethical committee.
Participants/Inclusion and exclusion criteria
Incision criteria : Age group of 25-70 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.
Intervention groups
The three treatment groups were treated with therapeutic deep tissue massage with three ways: first group was treated with jasmine oil manually massage, second group was treated electric palm massage with jasmine oil massage and third group was treated with electric palm massager with-out jasmine oil. The deep tissue foot massage was applied by three ways on the feet of diabetics and hypertensive patients for 15 consecutive days. Each session was 30 minutes per day. Massage was applied for 15 minutes on each foot. After 15 days we were compare per and post blood pressure and glucose level in hypertensive and diabetics patients. We were measure objective data heart rate, respiration rate, blood pressure, and glucose level and oxygen saturation.
Main outcome variables
Increasing insulin and blood circulation in diabetic patients and was help in reducing mean of arterial pressure (MAP), heart rate, respiratory rate, and increases oxygen saturation in hypertensive patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230103057033N1
Registration date: 2023-01-10, 1401/10/20
Registration timing: retrospective

Last update: 2023-01-10, 1401/10/20
Update count: 0
Registration date
2023-01-10, 1401/10/20
Registrant information
Name
Ujala Hameed
Name of organization / entity
Ali ul Murtaza Departement of Rehabilitation Multan
Country
Pakistan
Phone
+92 316 6484756
Email address
ujalahameed947@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-16, 1401/03/26
Expected recruitment end date
2022-12-18, 1401/09/27
Actual recruitment start date
2022-06-01, 1401/03/11
Actual recruitment end date
2022-12-29, 1401/10/08
Trial completion date
2022-12-29, 1401/10/08
Scientific title
Comparative effects of therapeutic deep tissue foot massage with or without jasmine oil in diabetic and hypertensive patients
Public title
Therapeutic deep tissue foot massage with or without jasmine oil in diabetic and hypertensive patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group of 25-70 years Both Genders (Male, Female) Hypertensive patients Married and unmarried Educated and uneducated Diabetic patients
Exclusion criteria:
Any type of mental disability Lactating females Having any type of physical disability History of chest pain, bronchitis, asthma, angina, MI Chronic illness related to cardiorespiratory ailments Any type of major surgery• Pregnant females
Age
From 25 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 393
Actual sample size reached: 393
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. We used sealed envelops for lotterty method and randomization of participants was done. Randomization of participants in groups by lottery method and statistical analysis without biasness
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blinded study was done by keeping blind i-e the physiotherapist as Investigator and data analyser
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Muhammad Institute of Medical and Allied Sciences Multan
Street address
No. 142, Multan
City
Multan
Postal code
66000
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
MIMAS/29/IRB/IMRAN

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic chronic kidney disease

2

Description of health condition studied
Hypertension
ICD-10 code
I15.9
ICD-10 code description
Secondary hypertension, unspecified

Primary outcomes

1

Description
Increase in Blood circulation and insulin secretion in diabetic patients
Timepoint
3 weeks
Method of measurement
Blood glucose level by glucometer

2

Description
Mean arterial pressure
Timepoint
3 weeks
Method of measurement
Mercury manometer

3

Description
Heart rate
Timepoint
3 weeks
Method of measurement
Heart rate measuring device

4

Description
Oxygen saturation
Timepoint
3 weeks
Method of measurement
pulse oximeter

5

Description
Respiration rate
Timepoint
3 weeks
Method of measurement
manually

Secondary outcomes

1

Description
Increase in blood circulation
Timepoint
3 weeks
Method of measurement
Devices

Intervention groups

1

Description
Control group: 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, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again.
Category
Treatment - Drugs

2

Description
Intervention group: 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. Blood glucose level will be monitored by glucometer of patients (Diabetics and Hypertensive) by pin-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again.
Category
Treatment - Drugs

3

Description
Intervention group: Treated with electrical massager without jasmine oil.electric palm massager without jasmine oil will be applied in diabetics and hypertensive patients. Blood glucose level will be monitored by glucometer of patients (Diabetics and Hypertensive) by pin-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-Ul-Murtaza Department of Rehabilitation Sciences,Muhammad Institute
Full name of responsible person
Maliha Khalid Khan
Street address
Hbl street sabsazar metro station
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
DrMalihatareen@mimas.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Maliha Khalid Khan
Street address
Hbl street sabsazar metro station
City
Multan
Postal code
66000
Phone
+92 316 6484756
Email
ujalahameed947@gmail.com
Grant name
Student fund
Grant code / Reference number
26082022
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Institutional Funding policy
Proportion provided by this source
50
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
Muhammad Institute od Medical and Allied Sciences, Multan.
Full name of responsible person
Maliha Khalid Khan
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
142
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 316 6484756
Email
DrMalihatareen@mimas.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Imran Ahmad Khan
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
142
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences Multan
Full name of responsible person
Ujala Hameed
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
142
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 316 6484756
Fax
Email
ujalahameed947@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further formation
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document
There is no further information
Comments
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