determining the effect of acupressure and reflexology on constipation in pregnant women in health centers
Design
clinical trial with intervention and control group of phase zero randomization on 90 patient
Settings and conduct
this study is performed on 90 pregnant women aged 12 to 32 week who meet the inclusion criteria in health centers of birjand city by simple randomization
Participants/Inclusion and exclusion criteria
do you have constipation or moderate to high severity meaning someone has a score of 9on the pregnancy constipation scale in the last three days
Intervention groups
group acupressure-group reflexology-controlled
Main outcome variables
severe constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210626051706N1
Registration date:2021-12-20, 1400/09/29
Registration timing:registered_while_recruiting
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
fahime jamshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3220 0069
Email address
fahimejamshidi1366@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-28, 1400/09/07
Expected recruitment end date
2021-12-28, 1400/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative evaluating the effect of acupressure and reflexology on constipation in pregnant women in health center of birjand
Public title
comparative evaluating the effect of acupressure and reflexology on constipation in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
single pregnancy
you have moderate constipation
being in the 12- 32 week of pregnancy
no gastrointestinal disease
no history of colon surgery
no diabetes
do not take intestinal stimulant drugs
do not take medication that cause or aggravate constipation
no hyperthyroidism
no anxiety disorders
Exclusion criteria:
a score below 9,compared to a constipation test in the last three days
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
in this study ,among the health centers of birjand city from an area that were cully,socially and economically similar,were selected by available sampling method and then by simple random method one center as an acupressure group , one center as a reflexology group and another center of control group was selected
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 birjand university of medical siences
Street address
18,5 Pirozi,2GHaffari
City
birjand
Province
South Khorasan
Postal code
97711876411
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
Ir.bums.REC.1399.504
Health conditions studied
1
Description of health condition studied
constipation in pregnancy
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
severe constipation
Timepoint
before studying the first week ,the second week,the third week,the fourth week
Method of measurement
pregnancy constipation questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
the first group of acupressure intervention that massage in two points li11 and st36 by sixty people with a pressure of 3 to 4 kg for 16 minutes 12 times
Category
Other
2
Description
intervention group 2 reflexology group massage in the area of large and small intestine in the sole of the foot at the rate of 4 to 5 kg per foot for 8 minutes in 12 turns
Category
Other
3
Description
Control group: has not received any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Birjand health centers
Full name of responsible person
Fahime Gamshidi
Street address
18.Pirozi 5.GHafari 2
City
Birjand
Province
South Khorasan
Postal code
9771876411
Phone
+98 56 3220 0073
Email
Fahimejamshidi1366@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohamad Hasan Namaei
Street address
18.Pirozi 5,GHafari2
City
Birjand
Province
South Khorasan
Postal code
9771876411
Phone
+98 56 3220 0073
Email
fahimejamshidi1366@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Fahime Gamshidi
Position
Senior nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
18,GHafari2,Pirozi5
City
Birjand
Province
South Khorasan
Postal code
9771876411
Phone
+98 56 3220 0073
Email
fahimejamshidi1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahime Gamshidi
Position
Senior nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
18,GHafari 2,Pirozi5
City
Birjand
Province
South Khorasan
Postal code
9771876411
Phone
+98 56 3220 0073
Email
fahimejamshidi1366@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahime Gamshidi
Position
Senior nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
18,GHafari,Pirozi 5
City
Birjand
Province
South Khorasan
Postal code
9771876411
Phone
+98 56 3220 0073
Email
fahimejamshidi1366@gmail.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all data can be shared after being unidentified
When the data will become available and for how long
access period starts 3 months after printing
To whom data/document is available
university researchers
Under which criteria data/document could be used
there is no condition for access
From where data/document is obtainable
request a personal email
What processes are involved for a request to access data/document