Determine of effect of auricular acupressure on the constipation and that related quality of life among the elderlies in residential care home
Design
This study is a clinical trial with two groups (intervention and control), double blinded (the data analysis and participants) and randomized, with 25 patients in each group.
Settings and conduct
This study will be performed in a nursing home under the auspices of the Kerman Welfare Organization. In the intervention group, the auricular acupressure intervention will be performed for 10 days. Constipation and that related quality of life will be measured before the intervention, after the intervention and 10 days after the intervention in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient age between 65_85 years , Patient with constipation according to ROME IV diagnostic criteria , The patient's cognitive status score according to the Abbreviated Mental Test criteria is equal to or greater than 6
Exclusion criteria: who had local lesions/infection of the ears, or absence of ear , Doing a treatment program other than taking laxatives to relieve constipation , has had an abdominal operation in the past 6 months , Suffering from Alzheimer's disease, dementia or delirium disorder according to the physician's diagnosis and inclusion in the medical record
Intervention groups
the intervention includes was applied to seven auricular acupoints for 10 days using vaccaria seeds for the intervention group. After 5 days, auricular plasters with vaccaria seeds were directly removed and we attach new auricular plasters with vaccaria seeds on the other ear.participants in control group received only auricular plasters without vaccaria seeds for 10 days in seven auricular acupoints and no intervention will be made on them.
Main outcome variables
Constipation and that related quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024919N10
Registration date:2020-09-30, 1399/07/09
Registration timing:registered_while_recruiting
Last update:2020-09-30, 1399/07/09
Update count:0
Registration date
2020-09-30, 1399/07/09
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Investigation of auricular acupressure effects on the constipation and that related quality of life among the elderlies in residential care home
Public title
effect of auricular acupressure on the constipation and that related quality of life among the elderlies in residential care home
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 65_85 years
Patient with constipation according to ROME IV diagnostic criteria
The patient's cognitive status score according to the Abbreviated Mental Test is equal to or greater than 6
Possibility to participate in the project for 20 days
Ability to speak and understand Persian
Exclusion criteria:
who had local lesions/infection of the ears, or absence of ear
Previous experience with auricular acupressure over the past year
Doing a treatment program other than taking laxatives to relieve constipation
Has had abdominal surgery for the past six months
Suffering from Alzheimer's disease, dementia or delirium disorder according to the physician's diagnosis and inclusion in the medical record
Suffering from a wide range of physical and mental diseases affecting the constipation variable according to the physician's diagnosis and inclusion in the medical record
Age
From 65 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign the participants to the intervention and control groups, the stratified randomization method is used, so we use the stratified randomization method based on the consumption of liquids, fruits and laxatives, and then a simple random assignment.first all participants are classified according to the collected information based on the consumption of liquids, fruits and laxatives and then we list and number the sample participants and using SPSS software, participants are randomly divided into two groups and Controls are divided.So that men and women are divided into groups separately; Then, in each group, men and women are used in a stratified random and simple random method, and half of the men are in the intervention group and the other half are in the control group (the same will be done for women).
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are randomly assigned to one of the intervention and control groups by a statistician who is blind to the study and the data analyst does not know which data is related to the intervention group and which data is related to the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-09-07, 1399/06/17
Ethics committee reference number
IR.KMU.REC.1399.374
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
Constipation will be measured before the intervention and after the intervention and 10 days after the end of the intervention
Method of measurement
Patient Assessment of Constipation–symptoms questionnaire (PAC-SYM)
2
Description
constipation related quality of life
Timepoint
constipation related quality of life will be measured before the intervention and after the intervention and 10 days after the end of the intervention
Method of measurement
Patient Assessment of Constipation–Quality of Life Questionnaire (PAC-QOL)
Secondary outcomes
empty
Intervention groups
1
Description
the intervention includes was applied to seven auricular acupoints for 10 days using vaccaria seeds for the intervention group. Thus, to apply constant pressure on the ear during the day and night, we use Vaccaria seeds at seven specific points on the ear, and the researcher gently presses the vaccaria seeds three to four times a day until the elderly feel a slight pain. First, we clean the marked points on the patient's ear with 70% alcohol, then to apply continuous pressure on the ear during the day and night, auricular plasters with vaccaria seeds (0.5 * 0.5 cm) are used on the marked points. After 5 days, auricular plasters with vaccaria seeds were directly removed and we attach new auricular plasters with vaccaria seeds on the other ear , so we will have two 5-day periods, each ear alternately under auricular acupressure. if auricular plasters with vaccaria seeds are removed from the ear earlier than five days, the elderly are asked to immediately inform until apply new auricular plasters with vaccaria seeds. HuanQiu brand auricular plasters with vaccaria seeds made in China are used for acupressure.
Category
Other
2
Description
Control group: For the control group, participants in control group received only auricular plasters without vaccaria seeds for 10 days in seven auricular acupoints and only their receive usual daily care and no intervention will be made on them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Kerman Welfare Organization
Full name of responsible person
Alireza Asadi
Street address
No. 27, Jomhuri Eslami Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
7618816359
Phone
+98 34 3213 2215
Email
tavanbakhshi@behzisty.kr.ir
Web page address
http://www.behzisti-kr.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
No 2, Research and Technology Dept., Ibnsina Ave., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 7213
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.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