Protocol summary

Summary
This is a randomized intervention study which it also has a control group. Study group is included patients with at least two-year hypertension experience. Samples are chosen using convenience sampling method. Participants will be matched two by two according to the drug they use to decrease blood pressure, and then we will do a random allocation. Patients will be asked to complete a written consent form. We will use Thai reflexology foot massage method for two one-hour sessions lasting one month in massage therapy center. Also, patient’s blood pressure, pulse and relaxation feeling will be controlled before and after the massage therapy. Moreover, demographic, pharmaceutical and illness questionnaire will be used to assess patients’ anxiety level along with validated Spielberger’s questionnaire. Inclusion criteria are involved: 1) having no mental and disability disorders history and 2) having 40-65-year-old. Exclusion criteria also are included: having history of cancer, gout, bone tuberculosis, autoimmune, severe knee arthritis, rheumatism, chemotherapy, last two-year bone fracture down the knee area, any history of recent last two-year surgery and last five-year cardiac surgery (all of these criteria are considered in order to prevent damages which might affect participants during their massage). 14 samples were selected for each group through doing a preliminary study and using average result and overviewing previous studies. In order to prevent from sample loss (considering 25% chance of sample loss), we selected 18 samples for each group. It is estimated that the study will take 9 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201038606N1
Registration date: 2012-05-10, 1391/02/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-05-10, 1391/02/21
Registrant information
Name
Sahar Sajedi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5633 2811
Email address
s-sajedi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Care Services
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot massage on anxiety and blood pressure in hypertensive patients Referred to cardiac specialty hospitals clinics affiliated to Tehran University of Medical Sciences in1390
Public title
Effects of foot massage on anxiety and blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Hypertensive patients with at least 2 years experience with a minimum pressure of 140/90 2- Without any history of mental disorders and disability. 3- Patients are in the age group 40-65 4- Patient is physically able to participate in the intervention until the end of it. 5- Preferably they live in Tehran. Exclusion criteria: 1-Any history of cancer, gout, bone tuberculosis, autoimmune, severe knee arthritis, rheumatism, chemotherapy, bone fracture in the knee area down to last 2 years, any history of recent surgery to last 2 years, history of cardiac surgery to last 5 years (all of them prevent damages due to the participants during their massage) 2- Lossing any of Inclusion criteria.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Tehran University of Medical Sciences and Health care Services
Street address
School of Nursing and Midwifery, Nosrat Street, Tohid Square, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-04-21, 1391/02/02
Ethics committee reference number
90-04-61-14761-50320

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
A disorder characterized by a partial or complete loss of the normal integration between memories of the past, awareness of identity and immediate sensations, and control of bodily movements (see F44.-), but arising as a consequence of an organic disorder

2

Description of health condition studied
High blood pressure
ICD-10 code
I10
ICD-10 code description
High blood pressure

Primary outcomes

1

Description
Anxiety
Timepoint
2 times. Once before the first intervention and once after the last intervention
Method of measurement
standard Spielberger's questionnaire

2

Description
Blood Pressure
Timepoint
Before and after each massage session
Method of measurement
According mmHg using a mercury sphygmomanometer

Secondary outcomes

1

Description
Pulse
Timepoint
Before and after each massage session
Method of measurement
Enumeration

2

Description
Relaxation feeling
Timepoint
Before and after each massage session
Method of measurement
100-mm visual analog scale

Intervention groups

1

Description
In control group, validated Spielberger questionnaire will be completed to assess the level of manifest and latent anxiety in 2 steps (in first visit and see after a month) and research teammate (he doesn’t know who is in case or control group) will control and record blood pressure and the rest of vital signs.
Category
Other

2

Description
Intended intervention is Thai reflexology foot massage that Participants in the study will be massaged in 1 month, 2 times a week; each session lasting one hour in massage therapy center has been considered. Massage therapy in this center will be did free by a Massager who has massage therapy degree that is approved by the Ministry of Health, Thailand and also he is member of the traditional medicine group, brightest talents center of Tehran University of Medical Sciences. So that after the person entering in the massage center, to change clothes and Washing and disinfecting legs will go to special washing and changing clothes room. After that, the feet will be dried and the person will sit down on a massage chair. The massager after doing a series of specific movements on the left foot starts to do massage with foot massage special oil and cream. Then with using a special timber called a steak, specific actions will be done on foot. Then Massage oils and creams are used again. After several movements, the person is given foot massage to above the knee. After this step, the left foot is wrapped in towel. Right foot is performed massage as the left foot. Then somewhere of the left foot is squeezed to massage effects be moved to the whole body (reflexology). And after that somewhere of the right foot is squeezed as left foot. Then on both feet simultaneously perform certain movements and massage will be completed. Before and after the each massage session Systolic and diastolic blood pressure will be controlled and will be recorded in a chart by researcher. Also, with using a 100 mm visual analog scale, patient’s relaxation feeling will be determined by him. After a month, validated Spielberger questionnaire will be completed to assess the level of manifest and latent anxiety and research teammate (he doesn’t know who is in case or control group) will control and record blood pressure and the rest of vital signs.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiac specialty hospitals clinics covered by Tehran University of Medical Sciences
Full name of responsible person
Tahereh Najafi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health care Services
Full name of responsible person
Dr. Fotouhi
Street address
Sixth Floor, Central organization of Tehran University of Medical Sciences and Health care Servicess,ghods street ,keshvarz Boulevard, Tehran, Iran, Ghods st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health care Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health care Services
Full name of responsible person
Tahereh Najafi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat street, Tohid square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4323
Fax
Email
najafi_t@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health care Services
Full name of responsible person
Tahereh Najafi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat street, Tohid square, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4323
Fax
Email
najafi_t@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health care Services
Full name of responsible person
Tahereh Najafi
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat street, Tohid square, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
najafi_t@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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