Determining and comparing the effect of abdominal massage with traditional Thai medicine and plum on constipation in elderly women
Design
This study is a clinical trial with a control group, parallel groups, and a blind. 105 elderly people will be divided into 3 groups (two intervention and one control group) by simple random division method using random numbers table and will be divided again separately.
Settings and conduct
The research is a single-blind clinical trial study. The research community will be elderly women referring to the number one comprehensive health service center in Rafsanjan city, and according to Rome 3 tool, constipation will be confirmed in them. 105 people were selected from among those who met the criteria for entering the study and the samples were divided into three groups of 35 people by a simple random method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60-75 years
Mental alertness and ability to answer questions
The presence of primary type constipation and its confirmation based on Rome 3 criteria
Absence of sores at the pressure point
Not having a special diet to treat constipation
Exclusion criteria: 1- lack of personal satisfaction to continue the research, 2- treatment of constipation with drugs, 3- foot, 4- travel, 5- failure to follow up according to the plan
Intervention groups
The recipient group will receive abdominal massage for 8 weeks, two sessions per week, and each session will last for 20 minutes. Abdominal massage will be performed 2 hours after breakfast by an elderly person trained by the researcher.
The other intervention group consumes 50 grams of plums half an hour after lunch two days a week for 8 weeks. The control group will only receive routine care such as blood pressure measurement on a monthly basis.
Main outcome variables
Constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N35
Registration date:2024-08-12, 1403/05/22
Registration timing:prospective
Last update:2024-08-12, 1403/05/22
Update count:0
Registration date
2024-08-12, 1403/05/22
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the use of traditional Thai stomachics and consumption of plums on constipation in elderly women
Public title
A comparative study of the effect of traditional Thai abdominal massage and plum consumption on constipation in elderly women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60-75 years
Mental alertness and ability to answer questions
The presence of primary type constipation and its confirmation based on Rome 3 criteria
Absence of sores at the pressure point
Not having a special diet to treat constipation
Lack of regular physical activity
No dependence or addiction to any drugs
No history of recent abdominal trauma
No skin disease
Not using anti-constipation and anticholinergic drugs
No history of neurodegenerative diseases
Not having a body mass index greater than 34.9 (due to the increase in abdominal fat in obese people, it is not possible to perform a massage with the right pressure)
Exclusion criteria:
Lack of personal consent to continue the research
Treatment of constipation with medicine
Death
Travel
Failure to follow up according to plan
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the people with indicators into the study and listing them, they are divided into 3 groups of 35 people A, B and C by simple random division method using a random number table, and then again the groups are divided by simple random division and the type of they give. Intervention on each group (two intervention groups and one control group) It will be determined what intervention will be done on each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the study, the researcher is kept blind and at the end of each week, the constipation measurement scale is completed by the researcher's colleague in all three groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Emam Ali Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.RUMS.REC.1403.076
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
Timepoint
Before the intervention and on days 7, 14, 21, 28, 35, 42, 49, 56 after the intervention
Method of measurement
Constipation Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: in the group receiving abdominal massage for 8 weeks and two sessions per week (Saturday and Tuesday), each session for 20 minutes abdominal massage 2 hours after breakfast (according to the requirements of Thai massage, which must be one hour from the meal is past) will be done by a person from the elderly family trained by the researcher.
Category
Treatment - Other
2
Description
Intervention group 2: The other intervention group consumes 50 grams of plums that are hygienically packed by the researcher, half an hour after lunch, for 8 weeks and two days a week (Saturday and Tuesday). The group of people will visit the center on a weekly basis and receive their weekly allowance
Category
Treatment - Other
3
Description
Control group: The control group will only receive routine care such as blood pressure measurement on a monthly basis
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 1 in Rafsanjan city
Full name of responsible person
Tayyebeh mirzaei
Street address
Faculty of Nursing، Nurse Blvd، Jomhury street، Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.mirzaei@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr.Reza Vazirinejad
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3131 5075
Email
rvazirinejad@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam Ali Bolv., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam Ali Bolv., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tayebeh Mirzaei
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Emam Ali Bolv., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
t.mirzaei@rums.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