Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05251818 |
| Other study ID # |
Resmiye-03 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2021 |
| Est. completion date |
March 9, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
Aydin Adnan Menderes University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Enema application to pregnant women and prohibition of oral feeding before cesarean section,
general anesthesia applied during cesarean section, pain in the post-cesarean period,
limitation of movement, insufficient fluid intake, low-fiber diet, hospital environment and
drugs such as narcotics cause constipation. In addition, one of the most common complications
after abdominal surgeries is postoperative ileus. Many noninvasive applications help to
overcome this problem. This study was planned as a randomized controlled trial to examine the
effect of acupressure on bowel functions after cesarean section. The research will be carried
out between July 2021 and July 2022 at the Samsun Training and Research Hospital Gynecology
and Pediatrics Hospital affiliated to the Samsun Provincial Health Directorate. The research
will be carried out with two groups as acupressure and control group. The sample number was
calculated using the G*Power 3.1.9.2 program and the acupressure group: 26 and the control
group: 26. In order to increase the analysis power, the number of people for each group was
taken as 30 (n=60). It is planned to collect the data with the Postpartum Information Form.
After the women in the acupressure group come to the service, 2 applications will be made in
the first postpartum hour and 3 hours after the first application, and no application will be
made to the control group. Intestinal sounds will be monitored every hour until the first
bowel sounds are heard, and the "Postpartum Registration Form" given to the woman will be
received and recorded at the post-op 24th hour. The data of the research will be evaluated
using the Statistical Package for the Social Sciences 22.0 program. In the evaluation of the
data; descriptive statistics percentage, arithmetic mean±standard deviation, median and
minimum-maximum values will be given. Student t test, ANOVA test will be used for those with
normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not. Type 1
error level will be taken as 0.05. Pearson Correlation test will be applied to determine the
relationship between the intestinal functions of the experimental group and the tests.
Statistical significance level will be accepted as p<0.05
Description:
H01: There is no difference between the acupressure and control groups in terms of hearing
time of bowel sounds.
H02: There is no difference in gas removal time between acupressure and control groups.
H03: There is no difference between the acupressure and control groups in terms of time to
defecation.
This study was designed as a randomized controlled experimental study. The study will be
carried out between July 2021 and July 2022 in the "Samsun Training and Research Hospital
Gynecology and Pediatrics Hospital gynecology service".The universe of the research will be
women who gave cesarean section under general anesthesia in Samsun Training and Research
Hospital, Gynecology and Pediatrics Hospital.
The G-Power program was used to determine the sample of the study and it was planned to
recruit 60 women in total (acupressure group: 30 women, control group: 30 women). The data of
the research will be collected with the Postpartum Information Form created by the
researcher. Which group the participants will be in will be determined by the full
randomization technique on the website www.randomizer.org. After obtaining the permission of
the ethics committee and the institution to carry out the study, the women who had a cesarean
section will be met by going to the institution. Mothers who meet the research criteria will
be informed about the purpose, content and methods of the research, and verbal and written
consent will be obtained from those who want to participate. The researcher will fill in the
"Postpartum Information Form" by interviewing the pregnant women face-to-face before the
cesarean section, examining their socio-demographic and obstetric characteristics, and the
operation information from the patient's file after the cesarean section.
Postpartum Information Form: This form was developed by researchers based on the literature.
It consists of questions that include socio-domographic and obstetric characteristics and
surgical information. Within the scope of the research, 7 questions including
socio-demographic characteristics of pregnant women (age, education level, occupation, amount
of fluid intake, economic status, bowel habits before and during pregnancy), 8 questions
including obstetrical characteristics (gestational week, number of pregnancies, number of
abortions, miscarriage) number of children, number of living children, number of live births,
previous type of delivery, reason for cesarean section), 7 questions including surgery
information (time of start and end of surgery, fasting time before surgery, total amount of
fluid given during surgery, amount of blood lost during surgery, admission to the ward). date
and time, bowel function status of women after surgery) consists of a total of 22 questions.
Pre-Application In order to assess whether the questions have been understood, a preliminary
study will be conducted with five mothers before starting the study. As a result of the
evaluation, it will be evaluated whether there is a need for editing in the data forms and
adjustments will be made. Those included in the preliminary study will not be included in the
sample group.
Data Collection After acupressure, the woman will be ready to serve. The control process will
be any application.
A suitable environment will be prepared for mothers in terms of warmth and light, where
privacy can be protected. The application points will be determined with the acu-point device
by choosing the most comfortable position for the mother, leaving the application points
open. The most preferred points on intestinal functions were LI4 and TH6 points. LI4 (Hegu)
and TH6 pressure points will be applied consecutively. Depending on the preparation and
compression time on the 2 selected points (4 points with each point on the other extremity),
the session duration of an individual will be approximately 12 minutes. While practicing, the
researcher will check the time using a digital wristwatch with a stopwatch.
LI4: It is the point where the cambered muscle group is when the thumb and forefinger are
brought closer together. In other words, it corresponds to the midpoint of the metacarpal
bone of the index finger. This area is often preferred for problems such as face, head,
toothache, stomachache, abdominal pain, constipation, diarrhea, dysentery, dysmenorrhea,
amenorrhea, difficult or abnormal birth.
TH 6: Located on the outer side of the arm, 4 fingers above the wrist crease, on the midline
of the arm (between radius and ulna bones).
This point is used in the treatment of constipation, irritable colon disease, hoarseness.
First, after 2 minutes of pressure is applied to the LI4 compression point on both hands, the
TH 6 compression point on both arms will be applied consecutively without interruption.
Although there is a difference in the order of use of the determined acupressure points, in
this study, first LI4 and then TH 6 points will be performed. While practicing, the
researcher will control the time using a digital wrist watch with a stopwatch. The
practitioner has acupressure training on this subject.
Analysis of Data The data of the study will be evaluated using the Statistical Package for
the Social Sciences (SPSS) 22.0 program. All data will first be evaluated with
Kolmogorov-Smirnov for conformity to normal distribution and then analyzed according to
fitness for normal distribution. For descriptive statistics, percentages will be used in
general, arithmetic mean±standard deviation for those suitable for normal distribution,
median and minimum-maximum values for those that do not fit. In the analysis of the data,
student t test and ANOVA test will be used for those with normal distribution, and
Mann-Whitney U and Kruskal Wallis tests for those who do not. Type 1 error level will be
taken as 0.05.
