This study aimed to compare the effects of Goleghand and foot reflexology on constipation among the elderly referred to the specialized clinic in 22 Bahman hospital of Gonabad. Research community study (60 to 75 years) who acquired ROME III criteria for the treatment of constipation and are referred to the clinic 22-Bahman Hospital. They are based on at least two of the questionnaire ROME III criteria diagnosed with constipation and considering the inclusion and exclusion criteria were enrolled in the study. The sample size based on previous studies with regard to statistical formulas 30 patients in each group was determined. Reflexology group twice daily for 5 minutes each time, will do 2 weeks. The action for women and for men by helping Pzhvhshgraqa will be done by Research assistant. The intervention group received Goleghand, the consumption of Goleghand for half an hour before lunch (a teaspoonful in a cup of boiling water and after cooling) will be for 2 weeks. Daily consumption of Goleghand on your phone to remind and will ensure appropriate use. The subjects are asked to your bowel habits (number of stools, bloating, abdominal pain and vomiting) daily in a register office. Data weekly for 2 weeks by the investigator to be collected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031233020N1
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Tayebe Mirani Moghadam Bahabadi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
mirani-t2@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Gonabad University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effects of Goleghand and foot reflexology on constipation among the elderly
Public title
The Comparison of the effects of Goleghand and foot reflexology on constipation among the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: mentally alert and able to answer questions; from age 60 to 75 years; Verified constipation ROME III - criteria; Not having the metabolic disorder known as diabetes; Not having spinal cord injuries, the lack of a history of injuries, open wounds and surgery on the legs; no ant idiarrheal drugs, sympathomimetic, opioids, alcohol and psychoactive; informed consent to participate in research and informed consent elderly person or legal guardians; lack of experience important disease affecting the gastrointestinal obstructive disorders, such as constipation, intestinal inflammatory diseases, hypothyroidism, psychiatric disorder
; Lack of effective on constipation drug such as calcium.Exclusion criteria: unwillingness to continue participation in the study at any time of the study; The occurrence of acute complications during the intervention; Change your diet or use of laxatives for constipation during the study; Report any signs suggesting an allergic reaction to Goleghand; Lack of Goleghand on schedule.
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized method: random allocation of patients to Reflexology group and Goleghand group by random block method. Blind technique: An observer examining patients will not be aware of the type of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
Postal code
9691793718
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.GMU.REC.1395.74
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K59.0
ICD-10 code description
Primary outcomes
1
Description
flatulence
Timepoint
Before treatment, during treatment and 2 weeks after the intervention
Method of measurement
Bowel habits check list
Secondary outcomes
1
Description
Vomit
Timepoint
Before, during and two weeks after intervention
Method of measurement
Bowel habits check list
Intervention groups
1
Description
In the Goleghand group, before a lunch, a teaspoonful of Goleghand juice will be mixed in a boiling water bottle and then consumed after cooling for 2 weeks. In this research, sugar beet products prepared in Green Toba Gold Company (registration number of Food and Drug Administration 462264 and license number 0359-94-Q) containing 100 grams of rose petals and honey are used. In the reflexology group, after the preparation of the legs, reflexology massage in the specific area of the constipation on the foot of the foot will be performed twice daily, every 5 minutes for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
the specialized clinic in 22 Bahman hospital of Gonabad
Full name of responsible person
MIRANI MOGHADDAM TAIBE
Street address
GONABAD،Asian roadside, Gonabad University of Medical Sciences GONABAD
City
GONABAD
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad
City
Gonabad
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 of Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
tayebe mirani moghaddam
Position
MSc. student in nursing education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad