Instrumental and Non-Instrumental Perineal Message and Childbirth
Condition: Labor
Study type: Interventional

Summary: 
      Today, the increase in the costs of applications in the health care system makes it difficult
      for easy and inexpensive methods to be used based on evidence. In this study, the episiotomy
      rate, episiotomy length, perineal pain at birth and postpartum period, perineal trauma,
      newborn 1st min. and 5 min. It was planned as a Randomized Controlled Experimental study to
      examine the effect of APGAR score on birth outcomes such as the duration of the first and
      second stages of labor and birth satisfaction.

      The universe of the research was carried out between December 2021-2022 in University
      Hospital and City Hospital Pregnant women at 38-42 weeks of gestation who are admitted to the
      maternity ward to give birth. Power analysis was performed using the GPower program in order
      to sample size. In determining the sample size, the article titled "The Effect of Perineal
      Massage During Labor in Nulliparous Women on Birth Comfort, Perineal Pain and Trauma" (Yaşar,
      2019) was used. Considering the total mean scores of the GCS scale in intervention and
      control groups, Type 1 error amount was 0.01, test power was 0.99, and effect size was
      1.1276841; The minimum required sample size was determined as 80 (40 interventions + 40
      control groups) for the intervention and control groups. In line with these data, it was
      decided that the sample size would be 120 pregnant women who agreed to be in the study and
      met the inclusion criteria, 40 in the intervention-1 group to be given instrumental perineal
      massage, 40 in the intervention-2 group that would receive non-instrumental perineal massage,
      and 40 in the control group.

      Frequency and mean values will be used in the evaluation of descriptive data, and independent
      sample t-test, chi-square test, fisher chi-square test and ANOVA will be used in the analysis
      of data showing normal distribution. The Mann Whitney U test is planned to be used in the
      analysis of data that do not show normal distribution. Normal distribution in the analysis of
      the relationship between prenatal instrument perineal massage and GCS scores, quality of
      pain, length of episiotomy, condition of the perineal region, duration of the first and
      second stages of labor, total delivery time, APGAR 1st and 5th minute scores, and parameters
      related to postpartum satisfaction Pearson correlation test will be used. All the results
      will be evaluated at the 95% confidence interval, at the 0.05 significance level.
    

Detailed description: 
      Randomization: In order to prevent the women in the intervention and control groups from
      being influenced by each other, a random selection was made between the two hospitals where
      the study would be conducted by drawing lots. According to this election, Tekirdag Dr. The
      women who will be included in the study from İsmail Fehmi Cumalıoğlu City Hospital will be
      included in the control group, and the women from the Tekirdağ Namık Kemal University
      Hospital will be included in the Intervention 1 and Interference 2 groups. Pregnant women to
      be sampled within intervention 1, intervention 2 and control groups will be determined by
      systematic random sampling method, one of the probabilistic sampling methods. The
      distribution within the group was made with a simple random selection method using the
      computer program module
      (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php).
      According to these results, the pregnant women to be included in the group are listed below
      in order of admission to the hospital.

      Intervention Group 1 (Instrumental perineal massage group); Between October 2020 and March
      2021, 86 women had normal vaginal deliveries in the obstetrics clinic of Tekirdağ Namık Kemal
      University Hospital. In this study, which was planned with reference to this number, the
      number of pregnant women to be included in the intervention1 group was made using a simple
      random selection method using the computer program module
      (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php). The
      order of application to the intervention 1 group 1. 4. 5. 8. 11. 14. 16. 20. 21. 23. 24. 25.
      28. 29. 33. 34. 35. 39. 40. 43. 44. 46. 47 Pregnant women who are 52. 53. 56. 58. 59. 63. 64.
      65. 70. 71. 72. 75. 76. 79. 82. 83. 86. will be taken.

      Intervention Group 2 (The group that will receive manual perineal massage); Between October
      2020 and March 2021, 86 women delivered vaginally to Tekirdağ Namık Kemal University
      Hospital's obstetrics clinic. In this study, which was planned with reference to this number,
      the number of pregnant women to be included in the intervention 2 group was made using a
      simple random selection method by using the computer program module
      (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php). The
      order of application to the initiative 2 group 2. 3. 6. 7. 9. 10. 12. 13. 15.17. 18. 19. 22.
      27. 30. 31. 32. 36. 38. 41. 42. 45. 48. 49. 51. 54. 55. 60. 61. 66. 67. 68. 69. 73. 74.
      Pregnant women who are 77. 78. 80. 81. 85. will be accepted. The pregnant woman who was
      excluded from the study due to any of the reasons stated in the randomization will be
      replaced by the pregnant who was admitted for the next delivery and her sequence number will
      be given to the next pregnant woman.

      Control Group; Tekirdag Dr. Between October 2020 and March 2021, 252 women delivered
      vaginally to İsmail Fehmi Cumalıoğlu City Hospital's maternity clinic. In this study, which
      was planned with reference to this number, the number of pregnant women to be included in the
      control group was made using a simple random selection method using the computer program
      module (https://www.calculatorsoup.com/calculators/statistics/random-number-generator.php).
      Tekirdag Dr. to the control group. The order of application to İsmail Fehmi Cumalıoğlu City
      Hospital as of October 2021 is 9 15 18 20 34 43 44 46 49 53 60 64 65 67 77 78 81 84 102 103
      108 118 120 128 131 136 152 158 163 171 178 179 184 186 187 198 205 206 228 230 pregnant
      women will be taken.

      If the hospital in the intervention and control groups receives the news that there is a
      pregnant hospitalization meeting the inclusion criteria at the same time, the pregnant women
      in this center will be given priority, since the number of births in the hospital planned to
      be included in the intervention group is lower.

      Data Collection Method: The application steps of the study are given below. Stage 1: A
      preliminary application will be made in the research, and the intelligibility, applicability
      and total application times of the forms/scales to be used in data collection will be
      evaluated. The pre-application is planned to be done on five pregnant women and it is planned
      to determine the problems in understanding the questions in the forms in line with the
      feedback. Among the women in both the intervention and control groups, the pregnant women who
      met the sampling criteria but did not accept the study or were taken to the cesarean section
      after accepting the study will be excluded from the study. The pregnant who had to be
      canceled due to any of the reasons stated in the randomization will be replaced by the
      pregnant hospitalized for the next delivery, and the targeted number of pregnant women will
      be reached by giving the next pregnant woman's sequence number. Determination of groups by
      randomization and obtaining their consent will be carried out at this stage. Personal
      Information Form, Labor Evaluation Form Part I, Visual Comparison Scale (GCS) will be applied
      to all pregnant women divided into groups in the latent phase of the first stage of labor.

      Stage 2: Instrumental perineal massage will be applied to the Interference-1 group, whose
      cervical opening is 4-8 cm and is in the active phase of labor. Materials to be used:
      Perineum massage device (EPİ-NO) is a water-based lubricant. The process will be applied in
      10 minutes, with two applications from the active phase to the transition phase and an
      average of one hour break after each application . Perineal massage will be performed at the
      same time intervals and for the same durations for the Initiative-2 Group, which receives
      manual perineal massage. Perineum massage will not be given to the control group pregnant
      women, and routine delivery room practices will be continued by the service workers. At this
      stage, the pregnant women are given the Labor Evaluation Form II. Section and GLO will be
      applied.

      3. Stage: It is the stage where the transitional phase of the pregnant women divided into
      groups is completed and the births take place. For all three groups, there was no other
      treatment except clinical routine applications.

      Stage 4: Within the first 48 hours of postpartum postpartum, Labor Evaluation Form III. It
      will be watched with the Chapter . If analgesia and local anesthesia are applied, it will be
      expected that the effect will wear off, and six hours after the second stage of labor, the
      puerperant women will be asked to mark the perineal pain level on the VCO visual. REEDA Scale
      will be used for the evaluation of the perineal area (Episiotomy, pole, tear).

      5th Stage: After confirming that no analgesic was used at least six hours before the
      postpartum was called by phone on the 10th day of postpartum, GCS for perineal pain level,
      REEDA Scale to evaluate the condition of the perineal area, and DME to assess satisfaction at
      birth. Data will be collected by querying with.

      Materials to be used in the research: Perineal massage device (EPİ-NO), water-based
      lubricant.
    

Intervention name(s): Instrumental perineal massage; manual perineal massage
Intervention type(s): Other; Other
Intervention description(s): In the active phase of labor, perineal massage will be performed with an instrument twice with an interval of one hour.; In the active phase of labor, manual perineal massage is performed twice an hour apart.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intervention I group (n:40) from two different experimental groups will be given instrumental perineal massage, and intervention II group (n:40) from the other experimental group will be given non-instrumental perineal massage. No intervention is planned for the control group (n:40).
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Labor Pain; Episiotomy; birth satisfaction; birth