Protocol summary

Summary
Objective: The effect of pelvic floor muscle exercise on wound healing indexes in women after colorectal surgery. The study population: consist of general surgery patients who have had recorded accounts in Vice-Chancellor in treatment affairs of Yasuj University of Medical Sciences. Inclusion and exclusion criteria: Inclusion criteria include female gender; not having diabetes and cancer; ability to read and write.Exclusion criteria included:patients unwillingnss for taking part in this study, getting worse of patients general situation and needs for hospitalization. Sample size: 48 patients in intervention group (group 1) and 48 patients in control group (group 2) were allocated. In Group 1 pelvic exercise program presented As a group to research units And they will be asked during an 14-days, two times a day to do exercise, so that way every time exercises should be 10 contraction 5 to 10 seconds in a state lying, sitting and standing and subsequent 10 seconds of rest is recommended. in control group( gruop2) No intervention was done. the primary out come: the rate of pain in women after colorectal surgeries.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030126862N1
Registration date: 2016-09-05, 1395/06/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Fatemeh Pirami
Name of organization / entity
Yasouj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 4115
Email address
fatemeh.pirami@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Science
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2016-09-02, 1395/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic floor muscle exercise on wound healing indexes in womens after colorectal surgery
Public title
The effect of pelvic floor muscle on pain and the recovery of wound in womens , after colorectal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria were: female gender; not having diabetes and cancer; implement one of colorectal surgery procedures; ability to read and write. Exclusion criteria included:patients unwillingnss for taking part in this study, Patient re-hospitalization due to complications after surgery.
Age
From 17 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Ninety-six patients underwent colorectal surgery by blocking will be divided into two groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yasuj
Postal code
00987591741417
Approval date
2016-04-30, 1395/02/11
Ethics committee reference number
IR.YUMS.REC.1395.21

Health conditions studied

1

Description of health condition studied
colorectal disease
ICD-10 code
k60, k61,
ICD-10 code description
other colorectal disease

Primary outcomes

1

Description
pain
Timepoint
Before and after exercising in the hours of 6, 12, 18, 24 and 48 after surgery
Method of measurement
Numeric pain scale

2

Description
Wound healing parameters
Timepoint
On days 3, 7 and 14 after operation
Method of measurement
Scale wound healing Reda

Secondary outcomes

empty

Intervention groups

1

Description
In Group 2, control group receive no specific intervention.
Category
Behavior

2

Description
the exercise program of floor muscles is presented to units in the intervention group, and asked them to do this exercise twice a day, in fourteen days, so that way every time exercises should be 10 contraction 5 to 10 seconds in a state lying, sitting and standing and subsequent 10 seconds of rest is recommended.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Office of an assisstant of treatment of Yasuj University of Medical Science
Full name of responsible person
shahla Najafidolatabad
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasouj

2

Recruitment center
Name of recruitment center
Yasuj University of Medical Science
Full name of responsible person
shahla najafidolatabad
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasouj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Yasuj University of Medical Sciences
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
Yasuj
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,Yasuj 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
Yasuj University of Medical Science
Full name of responsible person
Shahla Najafi Dolat Abad
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasuj
Postal code
00987433235141
Phone
+98 74 3323 4115
Fax
Email
shahlaiss@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj Univercity Medical science.
Full name of responsible person
Shahla Najafi Dolat Abad
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj, Iran
City
Yasuj
Postal code
00987433235141
Phone
+98 74 3323 4115
Fax
Email
shahlaiss@yahoo.com
Web page address
www.yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasuj Univercity of Medical Sciences
Full name of responsible person
Fatemeh Pirami
Position
Master student of nursing
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Shahid Motahary Blvd, Yasuj, Iran
City
Yasuj
Postal code
00987433235141
Phone
+98 74 3323 4115
Fax
Email
fatemeh.pirami@yums.ac.ir
Web page address

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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