Protocol summary

Summary
The purpose of this study was to compares the Efficacy of Reflexology and Abdominal Massage on Constipation.Samples will be selected among of male and female patients admitted to the orthopedic ward of Shohada Hospital in Tabriz city whose ages are18 years and older. Samples will be divided 3 groups (two experimental groups and one control group) using a computer random number table.Steps reflexology, reflexology in this case would be daily, 40 minutes per session,for each leg massage will be performed for 20 minutes.abdominal massage would be daily 20-minutes Clockwise by pressing the appropriate.Interventions will continue for a maximum of 7 days until the first Defecation.interventions will be conducted by the researcher for males and for females by a female research assistant, working daily in evening and when not to interfere with ward rounds and in patient bed.The data collected will be blinded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201410126918N19
Registration date: 2014-11-12, 1393/08/21
Registration timing: na

Last update:
Update count: 0
Registration date
2014-11-12, 1393/08/21
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Not enough for processing
Funding source
Research Assistance Tabriz University of Medical Sciences
Expected recruitment start date
2014-10-22, 1393/07/30
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Reflexology and Abdominal Massage on Constipation among Orthopedic Patients
Public title
Foot Reflexology and Abdominal Massage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients were men and women 18 and older،A score of 5 or higher on a scale of assessment of constipation،is having a large fracture، is having major surgery ،the same movement limitation،48 hours after admission، use of the same analgesics Exclusion criteria: cognitive and verbal ،Discharge before the fourth day،patient unwillingness to continue study
Age
From 18 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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Medical Sciences Research Assistance
Street address
Tabriz, Azadi Street, Golgasht Street , headquarters of Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-10-20, 1393/07/28
Ethics committee reference number
977-5138947

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
Bowel movements
Timepoint
End of Days
Method of measurement
Auscultation of the abdomen

Secondary outcomes

1

Description
Defecation
Timepoint
End of Days
Method of measurement
Ask the patient

Intervention groups

1

Description
Reflexology in this case would be daily, 40 minutes per session,for each leg massage will be performed for 20 minutes
Category
Treatment - Other

2

Description
abdominal massage would be daily 20-minutes Clockwise by pressing the
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Center oF shohada
Full name of responsible person
solmaz aydinfard
Street address
City
tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammadreza
Street address
Deputy of Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing & Midwifery Tabriz
Full name of responsible person
Alehe Seyedrasooli
Position
MS
Other areas of specialty/work
Street address
Shariety South St. Tabriz Faculty of Nursing & Midwifery
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
Email
aleheseyedrasooli@yahoo.com
Web page address

Person responsible for updating data

Contact

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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