The purpose of this study was to investigate the effect of foot reflexology on the severity and frequency of tension-type headache patients. This study is a randomized clinical trial study population to patients with neurological centers affiliated to Tehran University of Medical Sciences constitute town. Random sampling is done in two experimental and control groups
The study population: 80 patients. Inclusion criteria: tension headaches tend to participate in the study for medical diagnosis according to the patient's medical records. Exclusion criteria: consent to proceed with the project, create or constitute any spatial effects in the patient's legs during the study and completed the maximum two-week diary. In the case of 3-point reflexology foot reflexology including solar network (both feet of floor area, the midpoint of the second and third metatarsal bones connect) the pituitary (SP-1) in the toe of both feet and head (tip all toes) done.
3 minutes on each of these points reflexology done on both feet for a total of about 20 minutes duration.Reflexology massage 2 times a week for 20 minutes per session for 4 weeks has passed by the researcher who conducted the reflexology.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014013016426N1
Registration date:2014-11-30, 1393/09/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-30, 1393/09/09
Registrant information
Name
Seyed Hossein Vaez Zadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 939 633 0206
Email address
h-vaezzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Scienes
Expected recruitment start date
2014-10-29, 1393/08/07
Expected recruitment end date
2014-11-28, 1393/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on the pain intensity and frequency of patients with tension headache
Public title
The effect of foot reflexology on the pain intensity and frequency of patients with tension headache
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; written informed consent to participate in the study; tension headache diagnosis according to the patient's medical records; people with tension headaches have been to the doctor several times over; age over 18 years old; the ability of listening, speaking, and acceptable alertness for responding; no numbness, or paralysis of leg ulcers; drug and alcohol consumption; no record of having psychological disorders or psychosis; absence epilepsy; lack of cancer, especially lymphoma and nerve damage caused by diabetes; no risk of brain AVM; lack of headache medication escalation.
Exclusion criteria: no consent to proceed with the project; create or constitute any kind of side effects in the patient's legs cross over study; acute infectious disease during the study.
• Not completing the maximum two-week diary
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tehran University of Medical Sciences - Vice Chancellor for Research
Street address
Vice Chancellor for Research, Sixth Floor, Tehran University of Medical Sciences, Qods st., Tehran
City
Tehran
Postal code
Approval date
2014-10-29, 1393/08/07
Ethics committee reference number
1850/130 /ص/93
Health conditions studied
1
Description of health condition studied
Tension headache
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache
Primary outcomes
1
Description
Severity and frequency of pain
Timepoint
Before, during and after intervention
Method of measurement
Headache diary
Secondary outcomes
empty
Intervention groups
1
Description
How do reflexology, in which case the patient lying in the supine position and opposite the clinician and the patient is placed in a quiet environment. Preparations will be carried out before the main technique used to relieve tension and muscle spasms in the body. The toes with one hand and the other hand supporting his fists and feet to the junction of the fingers to the knuckles of the second leg, we massage it down. The medial border of the foot to the big toe side of the wrist to the ankle with a little pressure to make massage (performed three times on each leg).Reflexology in the footsteps of:1-point pituitary, leading the toe of the foot to the point of reflection for the pituitary is rotating clockwise massage for 3 minutes and we left.2. Solar Network: their hands in the shape of a cross. He then places a thumb on the cognitive reflection, as we do in the middle of the foot troughs. Thumbs on the inside leg and three times for 3 min massage is given.3-point reflects the brain: the tip of your toes all within 3 minutes of massage can be arranged at the outside of the thumb. At the last meeting the right and left foot and gently massage to give a blow, and then cover the legs. The patient breathe deeply and say 3 times at the end of the massage, the patient is recommended to drink plenty of fluids this intervention will be done by the researcher who specialized courses reflexology specialist is trained and certified for men and for women by a woman who specialized courses reflexology specialist is trained and certified in the site of clinics and room choice that has already been done.
Category
Other
2
Description
In the control group no intervention will be done. Just before, during and after the study questionnaires related to the frequency and severity of headaches is completed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Seyed Hossein Vaezzdeh
Street address
Imam Khomeini Hospital, Keshavarz Blvd.Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences - Vice Chancellor for Research
Full name of responsible person
Dr. Masoud Younesian
Street address
Vice Chancellor for Research-Sixth Floor Research- Tehran University of Medical Sciences –qods st-tehran-iran
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 - Vice Chancellor for Research
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
Full name of responsible person
Seyed Hossein Vaezzdeh
Position
MSc student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat st., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4326
Fax
Email
vaezzadeh1@gmail.com; h-vaezzadeh@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Forough Rafii
Position
Professor of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing, Rashid Yasemi st., After Vanak sq., Valiasr st.
City
Tehran
Postal code
Phone
+98 21 8888 0888
Fax
Email
foroughrafii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Hossein Vaezzdeh
Position
MSc student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Nosrat st., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4326
Fax
Email
vaezadeh1@gmail.com; h-vaezzadeh@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)