Comparing the effect of foot reflexology and acupressure on treatment of headache in patient receiving Nitroglycerin infusion in female patients admitted to cardiac emergency department
Comparing the effect of foot reflexology with acupressure on treatment of headache in patient receiving Nitroglycerine infusion in female patients admitted to cardiac emergency department. This study is clinical trial study will be conducted in treatment of headache on patients receiving Nitroglycerine infusion in Martyr Rajaei Hospital of karaj. Ninety nine eligible female patients will enter to study randomly, then allocate to the foot reflexology (n=33), acupressure (n=33) and placebo (n=33) groups, randomly. Ninety nine patients receiving Nitroglycerine infusion will be selected with available sampling method and then using permuted block randomization allocated in three groups foot reflexology (n=33), acupressure (n=33) and placebo (n=33). Intensity and quality of headache, and also vital sign will be measured in all three groups. The intervention is reflexology massage, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes. The intervention is acupressure, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes. In intervention group acupressore will be done in hegu point for 2 minutes and rest for 2 minutes and this procidure was repeated for 10 minutes. At 15 minutes after the first intervention, the second intervention will be repeated for 10 minutes. Touch will perform that is not linked to head will be massaged in the placebo group.. Intensity and quality of headache intensity will be used after the first intervention and after second intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201711107529N16
Registration date:2017-11-20, 1396/08/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University Vice chancellor for research
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of foot reflexology and acupressure on treatment of headache in patient receiving Nitroglycerin infusion in female patients admitted to cardiac emergency department
Public title
Comparing the effect of foot reflexology and acupressure on treatment of headache in patient receiving Nitroglycerin infusion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willing to participate in the study; age between 18 to 65; The absence of verbal and visual disorders; The absence of sensory-motor disorders; The absence of advanced neurological disorders; The absence of clotting problems, peripheral vascular disease, peripheral neuropathy and DVT limb; The absence of diagnosed psychiatric disorder; The absence of a headache before the administration of Nitroglycerine; the absence of any history of headache in patients; not having an addiction to drugs, sedatives, alcohol; Not using analgesics and nerve- muscle blockers 4 hours before the intervention; not having a long history of taking Nitroglycerine; The absence of history of using reflexology or acupressure; Not using of steroidal and non-steroidal anti-inflammatory drugs, anticoagulation, chemotherapy.
Exclusion criteria: Incidence of severe complications during the study; Pain in other parts of the body other than the head; the severity of the pain so that the patient can not tolerate; Use analgesics drugs during the study; Dissatisfaction of attending physician or patient.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Eligible patients will be selected through convenience sampling and will be randomly assigned into 2 groups using permuted block randomization with allocation ratio of 1: 1: 1. Random allocation sequence will be determined using a computerized program. Opaque sealed sequentially numbered envelopes from number 1 to 99 will be used for allocation concealment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Postal code
Approval date
2017-11-06, 1396/08/15
Ethics committee reference number
Shahed.REC.1396.50
Health conditions studied
1
Description of health condition studied
Drug-induced headache
ICD-10 code
G44.4
ICD-10 code description
Drug-induced headache, not elsewhere classified
Primary outcomes
1
Description
Intensity of headache
Timepoint
Before the intervention , after the first intervention and after second intervention
Method of measurement
Visual Analog Pain Scale
2
Description
Quality of headache
Timepoint
Before the intervention, after the first intervention and after second intervention
Method of measurement
McGill Pain Questionnaire
Secondary outcomes
1
Description
Heart rate
Timepoint
Before the intervention, after the first intervention and after second intervention
Method of measurement
Monitoring system
2
Description
Systolic Blood pressure
Timepoint
Before the intervention, after the first intervention and after second intervention
Method of measurement
Monitoring system
3
Description
Diastolic blood pressure
Timepoint
Before the intervention, after the first intervention and after second intervention
Method of measurement
Monitoring system
4
Description
Mean blood pressure
Timepoint
Before the intervention, after the first intervention and after second intervention
Method of measurement
Monitoring system
5
Description
Respiratory rate
Timepoint
Before the intervention, after the first intervention and after second intervention
Method of measurement
Monitoring system
6
Description
Oxygen saturation of arterial blood
Timepoint
Before the intervention, after the first intervention and after second intervention
Method of measurement
pulse oximeter
Intervention groups
1
Description
The intervention is reflexology massage, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes. The intervention is acupressure, the upper part of the patient's toe, the spot of reflection related to head will be massaged for both legs in the intervention group at two steps for 20 minutes.
Category
Treatment - Other
2
Description
In intervention group acupressore will be done in hegu point for 2 minutes and rest for 2 minutes and this procidure was repeated for 10 minutes. At 15 minutes after the first intervention, the second intervention will be repeated for 10 minutes.
Category
Treatment - Other
3
Description
Touch will perform that is not linked to head will be massaged in the placebo group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Rajaei Hospital
Full name of responsible person
Maryam Fatahi
Street address
City
karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice Chancellor For Research
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine Of Imam Khomeini, Tehran-Qom Express Way, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University 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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)