Clinical trial NCT05190913: Instrumental and Non-Instrumental Perineal Message and Childbirth
Official title: The Effect of Instrumented and Non-Instrumental Perineal Massage on Birth Results in the Active Phase of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Keywords: Labor Pain
Episiotomy
birth satisfaction
birth
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study
* No vision and hearing problems
* At least primary school graduate and no language problems
* Those between the ages of 18-35
* 38th-42nd of pregnancy. in the week
* Does not feel uncomfortable being touched by the genital area
* Those who are willing to have a normal delivery and have a vaginal delivery indication
* During the first stage of labor, analgesia and anesthesia are not used.
* Head presenter
* Single pregnancy
* Those who do not have a risky pregnancy (Dystosiler, Presanta previa, threat of premature birth, premature rupture of membranes, preeclampsia, eclampsia, hyperemesis gravidarum, ablatio placenta, placenta accreta, intrauterine growth retardation, cord anomaly, vaginal bleeding, etc.)

Exclusion Criteria:

* Non-Turkish citizens
* Planned cesarean section
* Having genital infection
* A different perineal massager
* Pregnant women with narcotic and analgesic addiction and who were administered narcotic analgesics during the data collection process.
* Known chronic disease (heart disease, hypertension, diabetes, kidney disease, etc.) systemic disease
* Having a neurological disease
* Non-pharmacological pain control methods at birth (respiratory exercise techniques, massage, intradermal water injection, relaxation and relaxation methods, mental/mental stimulation, Transcutaneous electrical nerve stimulation, etc.). using.

Primary outcomes:
measure: Labor Evaluation Form Part I
timeFrame: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 4 cm.
measure: Visual analog scale
timeFrame: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 4 cm.
measure: Labor Evaluation Form Part II
timeFrame: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 8 cm.
measure: Labor Evaluation Form Part III
timeFrame: This form is evaluated within 48 hours of postpartum
measure: REEDA Scale
timeFrame: The REEDA score is evaluated in the 48th hour after delivery.
measure: Birth satisfaction scale
timeFrame: This form is evaluated postpartum 10th day.
measure: Visual analog scale
timeFrame: The VAS is evaluated postpartum10th day.
Secondary outcomes:
measure: Visual analog scale
timeFrame: The progression time of vaginal dilatation at birth may vary from person to person. For this reason, the questionnaire will be applied at the beginning of the birth process, before the vaginal dilatation is 8 cm.
measure: Visual analog scale
timeFrame: The VAS is evaluated within 48 hours of postpartum after delivery
measure: REEDA Scale
timeFrame: The REEDA score is evaluated in the postpartum 10th day after delivery.
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Meryem Metinoğlu
state: Süleymanpaşa
Study officials:
affiliation: TNKU
name: Meryem Metinoğlu
role: PRINCIPAL_INVESTIGATOR
References:
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