Determine the Effect of Abdominal Massage with Olive oil on the severity of Constipation in the Elderly
Design
Single-blind randomized clinical trial, with three groups (intervention, placebo
and control), with parallel group
Settings and conduct
This study is a randomized clinical trial and elderly people will be divided into three groups of intervention, placebo and control according to a simple random method.
The sample size in each group is 18 people and the research site of the health centers of Gonabad community will be.
There will be no intervention for the elderly in the control group.
For the intervention group and placebo, massage therapy will be performed once a day for 20 minutes and for 5 consecutive days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Constipation according to Rome III criteria
Earn score 7 and above the elderly's daily activities questionnaire
Age over 60 years old
No-entrance criteria: organic constipation, hypothyroidism, false obstruction of the intestine, cystic fibrosis, neural anomalies, bowel obstruction, in the last month based on the patient's own case and report.
use of Constipation-Inducing Drugs such as Calcium and Iron Supplements, Antihistamines, Tricyclic Antidepressants, Anti-acidases in the last month based on patient records and reports.
Lesion in the abdomen and a massage position
Intervention groups
For elderly in the intervention group and placebo, massage therapy will be performed once a day for 20 minutes and for 5 consecutive days.
There will be no intervention for the elderly in the control group.
Main outcome variables
Severity of constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038821N1
Registration date:2018-10-19, 1397/07/27
Registration timing:registered_while_recruiting
Last update:2018-10-19, 1397/07/27
Update count:0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Iman Ghorbany Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 0576
Email address
ghorbani.i@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Abdominal Massage with Olive Oil on the Severity of Constipation in Elderly
Public title
The Effect of Abdominal Massage with Olive Oil on the Severity of Constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Constipation According to Rome III Criteria
Earn score 7 and above the elderly's daily activities questionnaire
Age over 60 years old
Exclusion criteria:
Organic Constipation, Hypothyroidism, False Obstruction of the Intestine, Cystic Fibrosis, Neuromuscular Anomalies and Bowel Obstruction in the Last Month based on the Patient's case and report.
Use of Constipation-Inducing Drugs such as Calcium and Iron Supplements, Antihistamines, Tricyclic Antidepressants, Anti-acidases in the last month based on patient records and reports.
Skin Lesion in the Abdomen and Massage Position
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the patients were selected by objective sampling method and applying the entry criteria. Then they were randomly assigned (coin throwing) in three groups: massage therapy with olive oil, massage therapy with placebo and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the participants, paraffin oil was used instead of olive oil for massage. Also, the person who completed the questionnaire on the quality of constipation was unaware of the allocation of patients in the studied groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnical Committee of Gonabad University of Medical Sciences
Street address
Asian Road Rim, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
96916-47161
Approval date
2017-12-22, 1396/10/01
Ethics committee reference number
IR.GMU.REC.1396.70
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Severity of constipation
Timepoint
Before the intervention and two days after the end of the intervention
Method of measurement
Constipation Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Abdominal massage with olive oil once a day for 20 minutes and for 5 consecutive days
Category
Treatment - Other
2
Description
Intervention group: Abdominal massage with paraffin oil once a day for 20 minutes and for 5 consecutive days
Category
Placebo
3
Description
Control group: There will be no intervention for the elderly.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Community health centers in Gonabad city
Full name of responsible person
Dr. Iraj Moradi
Street address
Imam Khomeini Avenue, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
info@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Javad Bazeli
Street address
Gonabad, Imam Khomeini Avenue, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Lila Mehrpor
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad, Imam Khomeini Avenue, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
lila.mehrpoor@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Asian Roads, Gonabad University of Medical Sciences, Faculty of Nursing
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
amohammadpur@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Lila Mehrpor
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad, Imam Khomeini Avenue, Medical University of Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
lila.mehrpoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
After receiving the results of the decision for the publication, I will produce results.