Determination and comparison of the effect of acupressure and massage on constipation of elderly women
Design
Clinical trials, with parallel groups, randomized
Settings and conduct
This study is a single-blind clinical trial. The research population of the elderly women referred to the first and second comprehensive health centers of Rafsanjan, who are suffering from constipation according to the Roman instrument. The sample size was estimated based on the statistical formula of 60 people. The samples were randomly divided into two intervention groups. So, after determining the elderly who are eligible to enter the study, their names are in the list, then the samples are included in the study according to the random numbers table.
Participants/Inclusion and exclusion criteria
Entry criteria include:
1- Elderly women 75-60 years old
2. Individuals who are mentally conscious and capable of answering questions
3. Constipation is confirmed in accordance with Roman criteria 3 and the constipation is the primary type.
4. The consent form has been completed
5. Amputations of the limb or the wound at the point of compression
6. No specific diet for constipation
7. Dependence or addiction to any drug
8. No history of recent trauma to the abdomen
9. Not having skin disease
10. Non-use of anti-constipation and anti-cholinergic drugs
Exit criteria include:
1) Individual dissatisfaction to continue the research
2- Change the diet during the study to eliminate constipation
Intervention groups
One intervention group for 5 days is trained by a trainee specialist for 3 minutes each day for 3 minutes under acupressure at ST36 (Zusanli). The other intervention group also has 5 days, 20 minutes by a researcher trained under a classical abdominal massage
Main outcome variables
Constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N12
Registration date:2018-08-21, 1397/05/30
Registration timing:registered_while_recruiting
Last update:2018-08-21, 1397/05/30
Update count:0
Registration date
2018-08-21, 1397/05/30
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
2018-08-01, 1397/05/10
Expected recruitment end date
2018-11-01, 1397/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Acupressure and Abdominal massage on constipation of elderly women
Public title
Comparing the effect of Acupressure and Abdominal massage on constipation of elderly women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly women 75-60 years old
Individuals who are mentally conscious and capable of answering questions
Constipation is confirmed in accordance with Roman criteria 3 and the constipation is the primary type.
The consent form has been completed
Amputations of the limb or the wound at the point of compression
No specific diet for constipation
Dependence or addiction to any drug
No history of recent trauma to the abdomen
Not having skin disease
Non-use of anti-constipation and anti- cholinergic drugs
Exclusion criteria:
Individual dissatisfaction to continue the research
Change the diet during the study to eliminate constipation
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, a blind researcher has been kept. At the end of each day, a questionnaire for the measurement of constipation is completed by a researcher-fellow in both groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences ethics committee
Street address
School of Nursing and Midwifery, Nurse Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2018-07-17, 1397/04/26
Ethics committee reference number
IR.RUMS.REC.1397.018
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 at first,second,third,forth and fifth after intervention
Method of measurement
Constipation Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group is subjected to acupressure at ST36 (Zusanli) for 5 minutes, each day for 3 minutes by a researcher trained by an acupuncturist.
Category
Treatment - Other
2
Description
Intervention group: The intervention group is subjected to classical abdominal massage for 5 days, each 15 to 20 minutes each day, by a trained researcher. Classic abdominal massage involves circular movements that are performed on the abdomen with surface and deep methods clockwise along the colon.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers No. 1 and six cities in Rafsanjan
Full name of responsible person
Tayyebeh mirzaei
Street address
Rafsanjan nursing faculty
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
Vice chancellor of Research, Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Shamsizade Ali
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
T.mirzaei@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research, 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
Dr Tayebeh Mirzaei
Position
PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Fax
Email
t.mirzaei@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Mirzaei
Position
PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Fax
Email
t.mirzaei@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Tayebeh Mirzaei
Position
PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Geriatric Care Research Center, Jomhoori Eslami Bolv
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Fax
Email
t.mirzaei@rums.ac.ir
Web page address
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
No more information.
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