Determining the effectiveness of oral sweet almond oil and abdominal massage in the treatment of chronic constipation
Design
The present study is a clinical trial with two intervention groups and a control group, with parallel, without blinded and randomized groups on 90 patients. Randomization will be done by lottery method using cards.
Settings and conduct
This study is a randomized clinical trial without blinding. In this study, all patients with constipation referred to the internal clinics of Fasa city are included in the study based on ROME IV criteria
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 60 years, patients who score one or more based on the constipation evaluation scale; Patients who have bowel movements less than three times a week. Exclusion criteria: The patient uses a specific drug that causes constipation; unwillingness to participate in the study for any reason.
Intervention groups
Two intervention groups will participate in this study. Group A (oral consumption of sweet almond oil) and group B (abdominal massage with sweet almond oil)
Main outcome variables
Constipation, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190917044802N9
Registration date:2023-08-25, 1402/06/03
Registration timing:prospective
Last update:2023-08-25, 1402/06/03
Update count:0
Registration date
2023-08-25, 1402/06/03
Registrant information
Name
Mostafa Bijani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5012
Email address
bizhani_mostafa@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of using sweet almond oil orally and abdominal massage in the treatment of chronic constipation
Public title
Effectiveness of using sweet almond oil orally and abdominal massage in the treatment of chronic constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Patients who score one or more on the constipation evaluation scale
Patients who have less than three bowel movements per week
Exclusion criteria:
The patient has taken a special drug that causes constipation
Unwillingness to participation in the study for any reason
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the sample size, it is estimated that there are 90 patients. Patients will be selected via convenience sampling. Then they will be randomly divided into three groups A, B and C. For this purpose, 90 cards will be prepared. 30 cards labeled A (oral consumption of sweet almond oil), 30 cards labeled B (abdominal massage with sweet almond oil) and 30 cards labeled C (control group) will be placed. After labeling, 90 cards were then put in an envelope and each patient was asked to draw out one card randomly. The group of patients will be determined based on the card labels.
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 Fasa University of Medical Sciences
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.FUMS.REC.1402.062
Health conditions studied
1
Description of health condition studied
chronic constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Constipation
Timepoint
Before and three days after the intervention
Method of measurement
Constipation Assessment Scale (CAS)
2
Description
Pain
Timepoint
Before and three days after the intervention
Method of measurement
Pain McGill Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the abdominal massage group with sweet almond oil, abdominal massage training will be done three times a day with 15 ml of sweet almond oil daily for 15 minutes with a depth of 2 to 4 cm for three consecutive days. Patients do the initial session in the presence of the researcher at the clinic, and if the researcher approves, the study will be continued at home and the researcher will follow up by phone.
Category
Treatment - Other
2
Description
Intervention group: In the oral sweet almond oil group, 5 ml of sweet almond oil will be given to the patients every 8 hours for 3 days, and the researcher will follow up by phone.
Category
Treatment - Drugs
3
Description
Control group: In the control group, according to common treatment methods, only drug therapy will be given to patients for three days (three times a day) with the diagnosis of an internal specialist.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Mostafa Bijani
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 330 8451
Email
bizhani_mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Akbar Farjad Far
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 917 330 8451
Email
farjad_2020@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071-53350994-6
Email
bizhani_mostafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071-53350994-6
Email
bizhani_mostafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Mostafa Bijani
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fars province, Fasa city, Ibn Sina square. Fasa University of Medical Sciences. Fasa Iran
City
Fasa
Province
Fars
Postal code
7461686688
Phone
071-53350994-6
Email
bizhani_mostafa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After finishing the study and publishing the results, researchers can use the results of this research by requesting the corresponding author. There is no time limit for using the information of this study
When the data will become available and for how long
There is no time limit for using the information of this study
To whom data/document is available
After finishing the study and publishing the results, researchers can use the results of this research by requesting the corresponding author
Under which criteria data/document could be used
After finishing the study and publishing the results, researchers can use the results of this research by requesting the corresponding author. There is no time limit for using the information of this study
From where data/document is obtainable
Dr. Mustafa Bijani. Associate Professor of Nursing Department. Fasa University of Medical Sciences
bizhani_mostafa@ yahoo.com
09173308451
What processes are involved for a request to access data/document
After finishing the study and publishing the results, researchers can use the results of this research by requesting the corresponding author