Nonpharmacological Method for Relief of Episiotomy
Condition: Pain
Study type: Interventional

Summary: 
      The study is a randomized controlled study to evaluate the effectiveness of acupressure
      applied to primiparous pregnant women who underwent episiotomy in the early postpartum
      period.

      The research was carried out between August 2022 and November 2022 at Düzce University Health
      Practice and Research Center with mothers who gave vaginal birth. The research was 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: 30 and the control group: 30. It was
      collected the research data with the Introductory Information Form and Visual Analog Scale.
      The participants in the acupressure group were interviewed at the 3rd and 5th hours after
      birth. The application announcement was made and they were allowed to sign the voluntary
      consent form. The VAS was filled by the participant before the application. Acupressure was
      applied to SP6, ST36 and LI4 points for a total of 12 minutes. After the application, the VAS
      was filled again by the participant.

      No application was made to the control group. The data of the research was evaluated using
      the Statistical Package 22.0 program for Social Sciences. In the evaluation of the data;
      descriptive statistics was given as percentage, arithmetic mean±standard deviation, median
      and minimum-maximum values. Independent two-sample t-test was used for normally distributed
      variables and Mann-Whitney U test was used for non-normally distributed variables. Pearson
      Correlation test was 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 was accepted as p<0.05.
    

Detailed description: 
      Aim: This study was planned to examine the effect of acupuncture on perineal pain after
      episiotomy in the early postpartum period.

      Research hypothesis:

      H0: Acupressure application applied to pregnant women who underwent episiotomy in the
      postpartum period has no effect on reducing the level of perineal pain.

      H1: Acupressure application applied to pregnant women who underwent episiotomy in the
      postpartum period reduces the level of perineal pain.

      Type of Study: This study was designed as a randomized controlled experimental study.

      Research Universe The population of the study consisted of participants who had vaginal
      birth, had episiotomy, and were primiparous , postpartum between the 3rd and 5th hours of the
      early postpartum period in Düzce University Health Practice and Research Center. The G- Power
      program was used to determine the sample of the study and it was planned to recruit a total
      of 60 participants ( 30 participants in the Acupressure group and 30 participants in the
      control group).

      Random number generation program " Research " It will be determined from Randomizer's website
      and divided into two groups. Thus, the number of each mother and the group number were
      determined and recorded.

      Research data "Participant Information Form, VAS (Visual Analog Scale ) for Evaluating
      perineal Pain )".

      Exhibitor Information Form It was prepared by the researcher within the framework of the
      literature. The form consists of a total of 31 questions questioning women's socio
      -demographic, obstetric and perineal pain information. It is applied to postpartum women on
      the 1st day after delivery.

      VAS (Visual analog scale) Evaluation of Perineal Pain The patient marks his or her pain on a
      10 cm ruler with "no pain" at one end and the most severe pain at the other. The patient is
      told that there are two endpoints and to mark any place between these points appropriate to
      the severity of the pain. The distance between the onset of painlessness and this point
      marked by the patient is measured in centimeters and recorded. 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 Study After obtaining the necessary permissions from the ethics
      committee and the institution for the implementation of the study, participants who had a
      vaginal delivery and met the inclusion criteria of the study were interviewed by the
      institution. Participants were informed that they could participate in the study without
      affecting the care received at the hospital and that they could leave the study at any time,
      and their voluntary consent was obtained. After the participants were included in the study,
      they were assigned to the study groups according to the electronic randomization table. The
      data were collected by face-to-face interviews by the researcher working in the delivery room
      of the hospital. VAS (Visual Analog Scale ) was filled in by the participants to evaluate
      postpartum perineal pain . The VAS (Visual analog scale), in which perineal pain was
      evaluated, was filled in by the participants in the postpartum acupressure group at the 3rd
      and 5th hours before and after the application. No application was made to the control group
      other than routine applications.

      Acupressure Application Technique An environment where privacy can be protected and there are
      no external stimuli was prepared for the participants. The application started by leaving the
      application points open and choosing the most comfortable position for the participants. For
      this study, 3 points (6 points in total on both sides from each point) were determined and
      these points are SP6, the 6th point of the spleen meridian, LI4, the 4th point of the large
      intestine meridian , and ST36, the 36th point of the stomach meridian. In addition, expert
      opinion was taken to determine the points. The practitioner will respectively apply circular
      motions to the points and then apply pressure within two minutes. Although there is a
      difference in the order of use of the determined acupuncture points, this study was performed
      symmetrically to the LI4, SP6 and ST36 points, respectively. The practitioner will have a
      stopwatch to control the time.

      Large Intestine Meridian Point 4 (He Gu /LI4):

      Position: It is the point where the cambered muscle group is located when the thumb and index
      finger 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 thumb/middle finger in a circular or up and down
      direction along the meridian line for 2 minutes. Work on 2 points on both hands separately or
      simultaneously. Signs of the Spot: Although this area is often used for face, headache and
      toothache , it is also a frequently preferred area to increase alertness and reduce fatigue.

      Indications: 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 inside of the shinbone, four fingers above the ankle.

      Application Technique: Press the point with thumb/middle finger in a circular or up and down
      direction along the meridian line for 2 minutes. Work on 2 points on both legs separately or
      simultaneously.

      Symptoms of the Point: This point, which is generally used for urological and pelvic
      problems, menstrual pain and insomnia, is also preferred in various studies to reduce
      fatigue.

      Stomach Meridian 36th Point (ST36):

      Location: It is located in the anterior part of the tibia, four fingers below the patella .

      Application Technique: Press the point with thumb/middle finger in a circular or up and down
      direction along the meridian line for 2 minutes. Work on 2 points on both legs separately or
      simultaneously.

      Spot Symptoms: Provides good digestive power and is effective in relieving constipation,
      diarrhea and bloating. It is a vital energy point in the prevention of diabetes, which can be
      caused by increased heartburn.

        -  Application to Acupressure Group

             -  The participants in this group were interviewed at the 3rd and 5th hours after
                birth. The application was announced and the voluntary consent form was signed.

             -  Participant Information Form was filled by the researcher through face-to-face
                interview.

             -  The VAS to be applied to evaluate perineal pain at the 3rd and 5th hours after
                delivery was filled out by the participant.

             -  The total duration of the application, in which SP6, ST36 and LI4 scores were
                applied for 2 minutes, was 12 minutes .

             -  After the application, the VAS Perineal Pain Evaluation form was filled by the
                participant.

             -  The participant was informed that the study was completed.

        -  Application to the Control Group

             -  The participants in this group were interviewed at the 3rd and 5th hours after
                birth. The application was announced and the voluntary consent form was signed.

             -  Participant Information Form was filled by the researcher through face-to-face
                interview.

             -  3. VAS (Visual analog scale) Evaluation of Perineal Pain was requested at 5th and
                5th hours.

             -  No application other than routine applications.

      Statistical and Analytical Methods:

      Statistical analysis will be performed using the IBM SPSS Statistic 22.0 (IBM Corp. , Armonk
      , NY, USA) program. Descriptive statistical methods (number, percentage, mean, standard
      deviation) will be used in the evaluation of sociodemographic data. Parametric tests
      (chi-square, T test, etc.) and non-paramedic tests (Mann-Whitney U Test, Kruskal Wallis,
      etc.) will be used in the comparison of categorical variables when it is seen that the data
      are suitable for normal distribution) will be used when it is not suitable for a normal
      distribution. P significance level will be accepted as 0.05 .
    

Intervention name(s): Acupressure group
Intervention type(s): Behavioral
Intervention description(s): 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 of the mother, leaving the application points open. The most preferred points LI4, SP6 and ST36 were selected among the points that were reported to be effective in relieving luterus pain by scanning the literature on the points to be compressed. Acupressure will be applied to the points (bidirectional, right and left) for 2 minutes, for a total of 8 minutes. Light pressure will be applied with the thumb of the practitioner's hand. Immediately after applying pressure for 2 minutes for each point, it is passed to the other point in the symmetrical region and the application is made without interruption. While practicing, the researcher will check the time using a digital wristwatch with a stopwatch.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Episiotomy, acupressure, pain