The effect of Kegel exercise on the flatulence and constipation during pregnancy and after vaginal delivery and cesarean
Design
Controlled randomized clinical trial in two groups (intervention and control groups)
Settings and conduct
This study is a single-blind, randomized clinical trial conducted in Shahidan Mobini Hospital and Sabzevar Health Care Centers. Sampling is convenience.
Participants Inclusion criteria were divided randomly into two case and control groups.Control group members are under prenatal care. In the case group, Kegel exercise is taught in addition to receiving routine care. The researcher tracks home exercise in the case group.
Bloating and constipation severity in both groups is presented to the researcher by information A and B at the start of the study, 8 weeks after the start and 10 and 42 days after delivery.
Participants/Inclusion and exclusion criteria
Pregnant mothers healthy
Minimum age 18 years olds
Ability to read and write
The desire to participate in the study
Single pregnancy
;
The presence of chronic medical conditions
History of pelvic and reconstructive surgery in the genital and urinary system Taking antibiotics 2 weeks before study
Intervention groups
Kegel exercises: In the intervention group , Kegel exercise is taught, in addition to receiving routine care .This group is trained to perform Kegel exercise on a daily basis three times a day every 20-15 minutes for 8 consecutive weeks.
Control group members are under prenatal care.the control group will also receive the conventional standard methods for improving constipation, such as increased fluid and fiber intake (celluloid material such as wheat and whole wheat, wheat bran, vegetables and fruits).
Main outcome variables
Constipation score; Bloating score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190427043386N1
Registration date:2019-05-14, 1398/02/24
Registration timing:prospective
Last update:2019-05-14, 1398/02/24
Update count:0
Registration date
2019-05-14, 1398/02/24
Registrant information
Name
Saideh Mehrabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4229 5284
Email address
saidehmehrabadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Kegel Exercises for Prevention and Treatment of Constipation and Flatulence in Antenatal and Postnatal.
Public title
The Effect of Kegel Exercises for Constipation and Flatulence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers healthy
Minimum age 18 years olds
Ability to read and write
The desire to participate in the study
Single pregnancy
Exclusion criteria:
The presence of chronic medical conditions
History of pelvic and reconstructive surgery in the genital and urinary system
Taking antibiotics 2 weeks before study
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
305
Randomization (investigator's opinion)
Randomized
Randomization description
Each mothers will be given a code. They are divided into two groups A and B based on random numbers.The type of group will be written and placed inside the matte and numbered envelopes for Allocation Concealment. The envelopes will be opened in order of entry and will be specified the type of group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will not be aware of the intervention and control groups and the participants in each group, and the data will be entered with the number of each participating and the type of group to which the participant has been assigned, is not specified.
care is different from the principal investigator. Information is available to the researcher in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar, Asad Abadi Ave, Central Office of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2019-03-15, 1397/12/24
Ethics committee reference number
IR.MEDSAB.REC.1398.002
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Severity of constipation based on pregnancy constipation measurement scale
Timepoint
The severity of constipation is measured before and 8 weeks of the study, as well as 10 and 42 days after delivery.
Method of measurement
pregnancy constipation measurement scale
2
Description
Intensity of bloating
Timepoint
The severity of bloating is measured before and 8 weeks of the study, as well as 10 and 42 days after delivery.
Method of measurement
Visual analog scall and Clinical examinations
Secondary outcomes
1
Description
Severity of Anxiety based on Spielberger State-Trait Anxiety
Timepoint
The severity of Anxiety is measured before and 8 weeks of the study, as well as 10 and 42 days after delivery.
Method of measurement
Spielberger State-Trait Anxiety scale
Intervention groups
1
Description
Intervention group: This group is trained to perform Kegel exercise on a daily basis three times a day every 20-15 minutes for 8 consecutive weeks. Kegel exercise training is under the supervision of a Masters of Midwifery.Also, during the referral for prenatal care, they are again evaluated about how to do the exercise.
Category
Prevention
2
Description
Control group: Routine care alone
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahidan Mobini Hospital
Full name of responsible person
Azam Zarghi
Street address
Kashefi Ave, Shahidan Mobini Hospital, Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4423 8100
Email
M.S@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte ghorat
Street address
Tohid Town, Sabzever Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
info@medsab.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Saideh Mehrabadi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 23, Rahnamai 17, Sabzevar Town.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617878131
Phone
+98 51 4229 5284
Fax
Email
saidehmehrabadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azam Zarghi
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 23, Rahnamai 17, Sabzevar Town.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617878131
Phone
+98 51 4229 5284
Fax
Email
a.zarghi59@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Saideh Mehrabadi
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 23, Rahnamai 17, Sabzevar Town.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617878131
Phone
+98 51 4229 5284
Fax
Email
saidehmehrabadi@yahoo.com
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