Compare the effect of foot reflexology massage on headache intensity in patients receiving intravenous nitroglycerin in the intervention, placebo and control groups
This study aimed to evaluate the impact of reflexology massage on headache caused by intravenous nitroglycerin in patients admitted to the hospital. This study is an experimental study (pre and post-test) will be conducted on patients receiving intravenous nitroglycerin in Seyyed-o-Shohada hospital of Urmia. Seventy five eligible patients will enter to study randomly, then allocate to the intervention (n=25), placebo (n=25) and control (n=25) groups, randomly. Inclusion criteria, including: being male, having a record in the mentioned hospital's wards and willing to participate in the study. Headache intensity will be measured in all three groups using the numerical pain scale. The intervention is reflexology massage. So, 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. An unspecified spot at the foot (heel) that is not linked to head will be massaged in the placebo group. The numerical pain scale will be used to evaluate the severity of headaches after the intervention. Reflexology massage is an independent variable and intravenous nitroglycerin induced headache is the dependent variable in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042922010N1
Registration date:2016-02-12, 1394/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-12, 1394/11/23
Registrant information
Name
Nima Imani
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 2394
Email address
imani.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of foot reflexology massage on headache intensity in patients receiving intravenous nitroglycerin in the intervention, placebo and control groups
Public title
The effect of reflexology massage on headache caused by intravenous nitroglycerin
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
- Willing to participate in the study.
- Not having cognitive or behavioral and vision disorders during the intervention that prevents using the numerical pain scale in the patients.
- Not having orthopedic problems or wounds, injuries and burns on the legs, as well as diabetic foot ulcers.
- Not having an advanced neurological disorder such as MS, Parkinson's disease, Guillain-Barre syndrome, progressive Myasthenia Gravis and diabetic neuropathy.
- Not having a serious physical or mental illness to prevent intervention.
- Not having a headache before the administration of nitroglycerin.
- Not having an addiction to drugs, sedatives, alcohol, etc.
- Not taking analgesics and nerve- muscle blockers shortly before the intervention.
- Not having a long history of taking nitroglycerin.
- Not having a history of using reflexology massage.
Exclusion criteria:
- Incidence of severe complications during the study.
- Patient death.
- Dissatisfaction of attending physician.
- Losing of the patient's consciousness.
Age
From 18 years old to 90 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
End of Emergency Alley, Resalat Boulevard, Urmia
City
urmia
Postal code
5714783734
Approval date
2015-04-29, 1394/02/09
Ethics committee reference number
umsu.rec.1394.28
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
headache
Timepoint
Before and immediately after the intervention
Method of measurement
Numerical Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
The patient's feet are cleaned using a wet towel. After cleaning the feet, the reflexology massage is given based on Ingham method. To do this, the patient's heel is held by left hand and foot is bent from the ankle. Then, upper part of the patient's toe, which is linked to the reflection spot of the head will be massaged. This procedure is performed for both legs for 20 minutes (10 minutes for each leg separately).
Category
Other
2
Description
In the placebo group an unspecified point in the foot (heel) that is not related to head, will be massaged.
Category
Placebo
3
Description
No action will be taken in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyyed Al-Shohada Hospital of Urmia
Full name of responsible person
Street address
In front of Samadzadeh Street, Shahrivar 17th Boulevard, Vali asr Boulevard
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
End of Emergency Alley, Resalat Boulevard, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Urmia University of Medical Sciences
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
Urmia University of Medical Sciences
Full name of responsible person
Shams Aldin Shams
Position
Master / Trainer
Other areas of specialty/work
Street address
End of Emergency Alley, Resalat Boulevard, Urmia
City
urmia
Postal code
Phone
+98 44 3275 4964
Fax
Email
shamsi_sh@umsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Nima Imani
Position
Master degree
Other areas of specialty/work
Street address
No. 39, Behnam Alley, Lida Alley, Parvin Etesami, Vali Asr Street
City
Tabriz
Postal code
Phone
+98 41 3327 2394
Fax
Email
nima.imany@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)