It is a non-randomized clinical trial that conducted in the Sina and Shariati hospitals of Tehran University of Medical Sciences. Using simple(convenience) sampling method, 120 patients with skeletal traction assigned to acupressure group(n=60) and control group(n=60). All patients received usual care nursing. Acupressure on Tianshu(ST25), Zhigou(SJ6), Hegu(LI4) points performed in experimental group for two min, twice a day for 3 days.The control group received only usual care nursing. After the first defecation, bowel movements measured by questionnaires. Finally, satisfaction with bowel movement is also measured by questionnaire.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201504225987N20
Registration date:2015-08-03, 1394/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-03, 1394/05/12
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-05-12, 1394/02/22
Expected recruitment end date
2015-08-26, 1394/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on bowel elimination in patients with skeletal traction
Public title
-
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 60 years; the ability to communicate in Persian; no hearing problem; no risk of gastrointestinal disorder such as irritable bowel syndrome and chronic constipation; lack of drug use; lack of mental illness; a limb skeletal traction or cervical vertebral of Krutchfield; lack of pregnancy; the patient is not NPO for 12 hours before intervention.
Exclusion criteria:
Serious disease that causes a change in bowel movements and unwillingness to continue the cooperation of the patient in the study at any time of the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Hospitals will be chosen by a coin toss.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Qods street, Keshavarz blvd, Tehran, Iran
City
Tehran
Postal code
1417614411
Approval date
2015-04-22, 1394/02/02
Ethics committee reference number
IR.TUMS.REC. 1394. 314
Health conditions studied
1
Description of health condition studied
bowel elimination in patients with skeletal traction
ICD-10 code
K55, K56,
ICD-10 code description
Other diseases of intestines
Primary outcomes
1
Description
Bowel elimination
Timepoint
First defecation after skeletal traction
Method of measurement
A questionnaire survey of bowel movements
Secondary outcomes
1
Description
satisfaction of defecation
Timepoint
after first defecation
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Before the start of the intervention, nurse researcher in the study received training by a certified traditional Chinese physition. Patients placed in the supine position, and then gradually, acupressure exerted with thumbs on the acupressure points: Tianshu(ST25), Zhigou(SJ6), Hegu(LI4) for 2 minutes until they felt pain or soreness. Procedure performed daily, once in the morning and again in the evening. The intervention started on the first day after the placement of the skeletal traction for 3 days. Bowel elimination questionnaire completed after first defecation. Finally, satisfaction with bowel movement is also measured by questionnaire.
Category
Other
2
Description
Control group: Patients in the control groups received only usual nursing care. Bowel elimination questionnaire completed after first defecation. Finally, satisfaction with bowel elimination is also measured by questionnaire.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Maryam Fadaei
Street address
Shariati hospital, Amir abad, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Maryam Fadaei
Street address
Sina hospital, Hassan abad square, Emam Khomeini street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of researcher, Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
The central building ot Tehran University of Medical Sciences, Qods street, keshavarz blvd, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of researcher, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Fadaei
Position
Master science student of nursing
Other areas of specialty/work
Street address
The faculty of nursing and midwifery of Tehran University of Medical Sciences, Nosrat street, Tohid square, Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
+98 21 6693 3600
Email
Maryamfadaei0@gmail.com
Web page address
www.fnm.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Associate professor
Other areas of specialty/work
Street address
The faculty of nursing and midwifery of Tehran University of Medical Sciences, Nosrat street, Tohid square, Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
+98 21 6693 3600
Email
Shghiyas@tums.ac.ir
Web page address
www.fnm.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Ghiyasvandian
Position
Associate professor
Other areas of specialty/work
Street address
The faculty of nursing and midwifery of Tehran University of Medical Sciences, Nosrat street, Tohid square, Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
+98 21 6693 3600
Email
Shghiyas@tums.ac.ir
Web page address
www.fnm.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)