Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05424861 |
| Other study ID # |
sdilek1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 16, 2022 |
| Est. completion date |
November 24, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Kocaeli University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Postpartum uterine pain is an important part of the postpartum period and is a concern for
women, which can negatively affect maternal-neonatal attachment and breastfeeding.
Acupressure allows midwives to make evidence-based independent practice in controlling
postpartum uterine pain. The aim of this study is to determine the effectiveness of
acupressure, which is a non-pharmacological intervention, for postpartum uterine pain after
vaginal delivery. The research will be carried out between February 2022 and December 2022
with mothers who gave vaginal birth at Health Sciences University Kocaeli Derince Training
and Research Hospital. The research will be carried out with two groups as acupressure and
control groups. The sample number was calculated using the G*Power 3.1.9.2 program and the
acupressure group: 61 and the control group: 61. It was planned to collect the research data
with the Introductory Information Form and Visual Analog Scale in which Postpartum Uterine
Pain was evaluated. Postpartum 6-24 days in the acupressure group. Acupressure will be
applied once between hours, just before breastfeeding. The visual analog scale, in which the
introductory information form is filled by the researcher and the pain score is evaluated,
will be marked by the participant once before breastfeeding, once at the 10th minute of
breastfeeding, and once at the 20th minute, in total 3 times. No application will be made to
the control group. The data of the research will be evaluated using the Statistical Package
22.0 program for Social Sciences. In the evaluation of the data; descriptive statistics will
be given as percentage, arithmetic mean±standard deviation, median and minimum-maximum
values. Independent two-sample t-test will be used for normally distributed variables and
Mann-Whitney U test will be used for non-normally distributed variables. Pearson Correlation
test will be applied to determine the relationship between the pain intensity of the
acupressure group and the tests and to determine the relationship between the tests.
Statistical significance level will be accepted as p<0.05.
Description:
Aim: The aim of our study is to determine the effectiveness of acupressure, which is a
non-pharmacological intervention, for postpartum uterine pain after vaginal delivery.
Hypothesis(s):
H0: Acupressure application during breastfeeding after vaginal delivery has no effect on
reducing uterine pain.
H1: Acupressure application during breastfeeding after vaginal delivery has an effect on
reducing uterine pain.
Type of Research: This study was designed as a randomized controlled experimental study.
Research Universe: The universe of the research will be multiparous mothers who have given
vaginal birth in the Alikahya Campus of Health Sciences University Kocaeli Derince Training
and Research Hospital. In order to determine the sample size in the study, De Sousa et al.
was calculated based on the study conducted by T.R. to examine the effect of transcutaneous
electrical nerve stimulation on postpartum uterine contraction pain during breastfeeding. The
sample size of the study was calculated using the G*Power 3.1.9.2 program and the mean and
standard deviation values of the uterine contraction pain variable in the related article (De
Sousa et al., 2014) were taken into account in calculating the effect size. The mean and
standard deviation values of the uterine contraction pain variable in the experimental group
were 3.56±1.78. In the control group, the mean and standard deviation values of the uterine
contraction pain variable were 4.81±2.37. Using the mean and standard deviation values of the
related article, the effect size was calculated as 0.5964125. The minimum number of
individuals to be included in the sample of this study was calculated by taking G*Power
3.1.9.2 and effect size: 0.5964125, α= 0.05, power: 0.90, and the sample size was determined
as at least 61 mothers in each group. (acupressure group: 61 and control group: 61). A total
of 122 women were planned to be included in the study (Acupressure group: 61 women, control
group: 61 women).
In which group the mothers included in the study will be, will be determined from the website
of the random number generation program "Research Randomizer", and they will be divided into
two groups. Thus, each mother's number and group number will be determined and recorded.
Data Collection Tools It is planned to collect the research data with the Introductory
Information Form and the VAS, in which Postpartum Uterine Pain is evaluated.
Introductory Information Form: This form was created by researchers based on the literature.
The form consists of a total of 24 questions questioning women's knowledge about
socio-domographic, obstetric and breastfeeding-related variables.
VAS for Evaluation of Postpartum Uterine Pain: The patient marks his or her own pain on a 10
cm ruler, which is marked as "no pain" at one end and the most severe pain at the other end.
The patient is told that there are two endpoints and to mark any place between these points
that matches the severity of the pain. The distance between the onset of no pain and this
point marked by the patient is measured and recorded in centimeters. It is stated that VAS is
more sensitive and reliable than other unidimensional scales in pain severity measurement.
The VAS is more sensitive than the simple descriptive scale.
Application Procedure of the Research After obtaining the approval of the ethics committee
and the permission of the institution, the mothers who had a vaginal birth in the last 24
hours and met the inclusion criteria of the study will be selected from the study, and those
who do not comply will be excluded from the study. In the literature, uterine pain associated
with breastfeeding is felt more intensely, especially after the first 6 hours after delivery,
until the 48th hour. In addition, multiparas experience more pain than primiparas. In the
hospital where we will study, women who have given birth normally stay for 24 hours and are
discharged afterwards. Therefore, multiparous women between 6-24 hours after their vaginal
delivery will be included in the study. Mothers who have given vaginal birth will be met
between the first 6-24 hours after the birth. Participants will be informed that they can
participate in the study without affecting the care received at the hospital and they can
leave the study at any time, and their consent will be obtained. After participants are
included in the study, they will be assigned to one of the study groups according to the
electronic randomization table. The data will be filled in by the researcher in the
Gynecology-3 service of the hospital by face-to-face interview, and the VAS for Evaluation of
Postpartum Uterine Pain will be filled in by the women themselves.
VAS Evaluation of Postpartum Uterine Pain by mothers;
- Postpartum 6-24. 1 time just before breastfeeding between hours,
- 1 time in the 10th minute of breastfeeding,
- It will be filled 3 times in total, once at the 20th minute of breastfeeding. To
mothers;
- Postpartum 6-24. Acupressure will not be applied to the acupressure group once between
hours, and no application will be made to the control group.
Location: 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.
Application Technique: Press the point with the thumb/middle finger for 2 minutes in a
circular or up and down direction along the meridian line. Work on 2 points on both legs
separately or simultaneously.
Indications of the Point: Although this area is generally used for face, head and toothache,
it is also a frequently preferred area to increase alertness and reduce fatigue.
Spleen Meridian 6th Point (Sanyinjiao/SP6):
Location: It is located on the inner side of the tibia, four fingers above the ankle.
Application Technique: Press the point with the thumb/middle finger for 2 minutes in a
circular or up and down direction along the meridian line. Work on 2 points on both legs
separately or simultaneously.
Indications of the Point: This point, which is generally used for urological and pelvic
problems, menstrual pain and insomnia, is also preferred to reduce fatigue in various
studies.
Acupressure Application Technique 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 exposed. Among the points reported to have an effect
on uterine pain for this study, acupressure application points are among the most preferred
points in the literature, spleen meridian point 6 (SP6) and large intestine meridian 4 point
(LI4), a total of 2 (from each point on both sides). : 4 points) detailed information about
the point is given below. In addition, expert opinion was taken to determine the points.
Light pressure will be applied with the thumb of the practitioner's hand. Immediately after
applying pressure for 2 minutes for each point, it will be moved to the other point in the
symmetrical region and the application will be made without interruption. Although there is a
difference in the order of use of the determined acupressure points, this study will be
carried out symmetrically to the LI4 and SP6 points, respectively. While practicing, the
researcher will control the time using a digital wrist watch with a stopwatch.
Large Intestine Meridian 4th Point (He Gu/LI4):
Location: 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.
Application Technique: Press the point with the thumb/middle finger for 2 minutes in a
circular or up and down direction along the meridian line. Work on 2 points on both legs
separately or simultaneously.
Indications of the Point: Although this area is generally used for face, head and toothache,
it is also a frequently preferred area to increase alertness and reduce fatigue.
Spleen Meridian 6th Point (Sanyinjiao/SP6):
Location: It is located on the inner side of the tibia, four fingers above the ankle.
Application Technique: Press the point with the thumb/middle finger for 2 minutes in a
circular or up and down direction along the meridian line. Work on 2 points on both legs
separately or simultaneously.
Indications of the Point: This point, which is generally used for urological and pelvic
problems, menstrual pain and insomnia, is also preferred to reduce fatigue in various
studies.
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 the Kolmogorov-Smirnov test for
conformity to normal distribution, and then analyzed according to conformity to 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. Comparisons between groups for numerical
variables of socio-demographic and clinical characteristics will be made with an independent
two-sample t-test for normally distributed variables, and Mann-Whitney U test for
non-normally distributed variables. Pearson Correlation test will be applied to determine the
relationship between the fatigue severity of the experimental group and the tests and to
determine the relationship between the tests. Statistical significance level will be accepted
as p<0.05.
