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The effect of abdominal massage on constipation in elderly patients with fracture

Protocol summary

Study aim
The effect of abdominal massage on constipation in elderly patients with fracture in Pursina Hospital of Rasht
Design
A clinical trial with the control group, parallel-group, randomized groups, without blinding, sample size 66 people (intervention of 33, control of 33)
Settings and conduct
This study is a randomized clinical trial. The study population is elderly with fractures hospitalized in the orthopedic department of Poursina Hospital in Rasht, who are suffering from constipation according to the Constipation Assessment Scale. The sample size is estimated based on the statistical formula of 66 people. After determining the elderly who are eligible to enter the study, the samples are randomly divided into two groups, intervention, and control, based on Random allocation software.
Participants/Inclusion and exclusion criteria
Entry criteria: Elderly men and women 60 years and older; Informed consent; Ability to respond to the questionnaire; Hospitalization due to fracture of more than 48 hours; Constipation based on the constipation Assessment Scale. Exit criteria: cognitive problems; History of mental illness, abdominal hernia, colorectal cancer, inflammatory bowel disease (Crohn's disease, IBD), irritable bowel syndrome and laparotomy; Skin lesions in the abdomen.
Intervention groups
In the intervention group, with 20 ml baby oil for 3 consecutive days, twice a day, morning and evening, during a 15-minute abdominal massage is done according to the instructions of the National Health Service.
Main outcome variables
Constipation score in Constipation Assessment Scale; Stool form; Gastrointestinal symptom rating

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190805044438N2
Registration date: 2020-04-16, 1399/01/28
Registration timing: prospective

Last update: 2020-04-16, 1399/01/28
Update count: 0
Registration date
2020-04-16, 1399/01/28
Registrant information
Name
Roya Mansour-ghanaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4256 5058
Email address
r_ghanaei@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-19, 1399/02/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of abdominal massage on constipation in elderly patients with fracture
Public title
The effect of abdominal massage on constipation in elderly patients with fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly men and women 60 years and older. Informed consent to participate in the study. Ability to respond to the questionnaire. Hospitalization due to fracture of more than 48 hours in the orthopedic department of the hospital under study. Determining the problem of constipation based on the constipation Assessment scale(CAS) [scoring above 5 on the constipation Assessment scale].
Exclusion criteria:
Cognitive problems, A history of mental illness, abdominal hernia, colorectal cancer, inflammatory bowel disease (Crohn's disease, IBD), irritable bowel syndrome and laparotomy. Skin lesions in the abdomen.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the patients were selected by applying the entry criteria. Then they were randomly assigned, based on Random allocation software, in two groups: massage therapy and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
4477163485
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.GUMS.REC.1398.525

Health conditions studied

1

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

Primary outcomes

1

Description
Constipation score in Constipation Assessment Scale (CAS)
Timepoint
Before intervention and 3 days after intervention
Method of measurement
Constipation Assessment Scale (CAS)

2

Description
Gastrointestinal symptom rating
Timepoint
Before intervention and 3 days after intervention
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)

3

Description
Stool form
Timepoint
Before intervention and 3 days after intervention
Method of measurement
Bristol Stool Form Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Abdominal massage with baby oil produced by Firooz Health Group for 3 consecutive days, twice a day, morning and evening, abdominal massage for 15 minutes with 20 ml of Firooz baby oil (To make it easier to move the hand on the patient's abdomen and Failure to cause discomfort to him), according to the instructions of the National Health Service (NHS) for the patient. This massage consists of 8 steps. 1. Three movements of the lower abdomen to the navel 2. Three movements from both sides of the pelvic to the pubic symphysis In the upper part and the whole abdomen 6. Repeat steps 4 and 5 .7. The horizontal movement of the abdomen from left to right 8. Vibration movements in all these points.
Category
Treatment - Other

2

Description
Control group:No specific intervention by the researcher will be performed on patients in this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Roya Mansour-ghanaei
Street address
Langeroud School of Nursing and Midwifery, Martyr Yaghoub Sheikhi St. leyla kooh, Langeroud, Guilan, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5059
Email
r_ghanaei@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohamadreza Naghipour
Street address
Deputy of university Research and Technology of the University, Old Bldg (building) School of Health, in front of 17 Shahrivar Hospital, Shahid Siadati Ave, Namjoo St, Rasht
City
Rasht
Province
Guilan
Postal code
4477163485
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
r_ghanaei@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour-ghanaei
Position
Assistant Professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Sciences
Street address
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5058
Fax
Email
r_ghanaei@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour-ghanaei
Position
Assistant Professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Sciences
Street address
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5058
Fax
Email
r_ghanaei@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Roya Mansour-ghanaei
Position
Assistant Professor, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Sciences
Street address
Martyr Yaghoub Sheikhi St., Leyla Kooh, Langeroud, Rasht, Iran
City
Langeroud
Province
Guilan
Postal code
4477163485
Phone
+98 13 4256 5058
Fax
Email
r_ghanaei@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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