LaborNCT05190913
Instrumental and Non-Instrumental Perineal Message and Childbirth
A study testing Instrumental perineal massage and manual perineal massage in people with Labor, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor
- What is being tested?
- Instrumental perineal massage and manual perineal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2021to 13 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Meryem Metinoğlu
Tekirdağ, Süleymanpaşa, 59030
About this study
Official title: The Effect of Instrumented and Non-Instrumental Perineal Massage on Birth Results in the Active Phase of Labor
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.
Read the 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.
- 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.
- Conditions
- Labor
- Being tested
- Instrumental perineal massage, manual perineal massage
- Keywords
- Labor Pain, Episiotomy, birth satisfaction, birth
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumental perineal massageOther
In the active phase of labor, perineal massage will be performed with an instrument twice with an interval of one hour.
manual perineal massageOther
In the active phase of labor, manual perineal massage is performed twice an hour apart.
| Study group | Role | What they receive |
|---|---|---|
| Initiative group I | Experimental | In the active phase of labor, perineal massage will be performed with the device at an interval of one hour. Receives: Other: Instrumental perineal massage |
| Initiative group II | Experimental | During the active phase of labor, manual perineal massage will be performed with an interval of one hour. Receives: Other: manual perineal massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor Evaluation Form Part I
- It will be applied in the latent phase of labor (cervical dilatation: 0-4 cm).
II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm).
III.Until two days after birth
Measured: 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.
Visual analog scale
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Measured: 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.
Labor Evaluation Form Part II
It will be applied during the active period of labor (cervical dilatation: 5-8 cm).
II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm).
III.Until two days after birth
Measured: 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.
Labor Evaluation Form Part III
It will be applied within the first 48 hours after the birth is completed.
Measured: This form is evaluated within 48 hours of postpartum
REEDA Scale
This scale includes five factors that indicate perineal wound healing. These; These are redness (redness), edema (edema), ecchymosis (ecchymosis), discharge (discharge), approximation (approaching wound ends). Each factor takes values between 0-3. A total REEDA score (0-15) is obtained by evaluating these five improvement factors. The lowest score is 0 points, the highest score is 15 points. Higher scores indicate more tissue trauma.
Measured: The REEDA score is evaluated in the 48th hour after delivery.
Birth satisfaction scale
The original of the scale used to evaluate women's perceptions of birth satisfaction is 30 items and is a five-point Likert type. It consists of 3 main themes: quality of care, personal characteristics of women and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.
Measured: This form is evaluated postpartum 10th day.
Visual analog scale
It is a scale used to evaluate the severity of pain. participants are asked to mark or say the point on the line numbered from zero to 10 that corresponds to the pain.Zero points; While expressing no pain, 10 points indicates the most severe pain experienced.
Measured: The VAS is evaluated postpartum10th day.
Secondary outcomes (3)
Visual analog scale
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Measured: 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.
Visual analog scale
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Measured: The VAS is evaluated within 48 hours of postpartum after delivery
REEDA Scale
This scale includes five factors that indicate perineal wound healing. These; These are redness (redness), edema (edema), ecchymosis (ecchymosis), discharge (discharge), approximation (approaching wound ends). Each factor takes values between 0-3. A total REEDA score (0-15) is obtained by evaluating these five improvement factors. The lowest score is 0 points, the highest score is 15 points. Higher scores indicate more tissue trauma.
Measured: The REEDA score is evaluated in the postpartum 10th day after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start22 Nov 2021
- Primary completion12 Dec 2022
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Metinoglu, Namik Kemal University
- Investigators
- Meryem Metinoğlu, Principal investigator, TNKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190913
- Sponsor's protocol ID
- TNKU-M.Metinoglu-001
- Status last verified
- Oct 2023
- First submitted
- 4 Dec 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelhakim AM, Eldesouky E, Elmagd IA, Mohammed A, Farag EA, Mohammed AE, Hamam KM, Hussein AS, Ali AS, Keshta NHA, Hamza M, Samy A, Abdel-Latif AA. Antenatal perineal massage benefits in reducing perineal trauma and postpartum morbidities: a systematic review and meta-analysis of randomized controlled trials. Int Urogynecol J. 2020 Sep;31(9):1735-1745. doi: 10.1007/s00192-020-04302-8. Epub 2020 May 12.
PubMed 32399905Dencker A, Nilsson C, Begley C, Jangsten E, Mollberg M, Patel H, Wigert H, Hessman E, Sjoblom H, Sparud-Lundin C. Causes and outcomes in studies of fear of childbirth: A systematic review. Women Birth. 2019 Apr;32(2):99-111. doi: 10.1016/j.wombi.2018.07.004. Epub 2018 Aug 14.
PubMed 30115515Jahani Shoorab N, Mirteimouri M, Taghipour A, Latifnejad Roudsari R. Women's Experiences of Emotional Recovery from Childbirth-Related Perineal Trauma: A Qualitative Content Analysis. Int J Community Based Nurs Midwifery. 2019 Jul;7(3):181-191. doi: 10.30476/IJCBNM.2019.44993.
PubMed 31341917O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
PubMed 34231203Manresa M, Pereda A, Bataller E, Terre-Rull C, Ismail KM, Webb SS. Incidence of perineal pain and dyspareunia following spontaneous vaginal birth: a systematic review and meta-analysis. Int Urogynecol J. 2019 Jun;30(6):853-868. doi: 10.1007/s00192-019-03894-0. Epub 2019 Feb 15.
PubMed 30770967Kavvadias T, Hoesli I. The EpiNo(R) Device: Efficacy, Tolerability, and Impact on Pelvic Floor-Implications for Future Research. Obstet Gynecol Int. 2016;2016:3818240. doi: 10.1155/2016/3818240. Epub 2016 Feb 14.
PubMed 26981126Martin CH, Fleming V. The birth satisfaction scale. Int J Health Care Qual Assur. 2011;24(2):124-35. doi: 10.1108/09526861111105086.
PubMed 21456488Demsar K, Svetina M, Verdenik I, Tul N, Blickstein I, Globevnik Velikonja V. Tokophobia (fear of childbirth): prevalence and risk factors. J Perinat Med. 2018 Feb 23;46(2):151-154. doi: 10.1515/jpm-2016-0282.
PubMed 28379837Metinoglu M, Beji NK. The Effect of Perineum Massage Applied With and Without an Instrument in the Active Phase of Labor Birth Outcomes: A Randomized Clinical Trial. Int Urogynecol J. 2024 Oct;35(10):1993-2002. doi: 10.1007/s00192-024-05901-5. Epub 2024 Sep 6.
PubMed 39240370
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instrumented and Non-Instrumental Perineal Massage on Birth Results in the Active Phase of Labor
- ClinicalTrials.gov ID
- NCT05190913
- Acronym / sponsor ID
- TNKU-M.Metinoglu-001
- Conditions
- Labor
- Keywords
- Labor Pain, Episiotomy, birth satisfaction, birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Initiative group I | Experimental | Other: Instrumental perineal massageIn the active phase of labor, perineal massage will be performed with the device at an interval of one hour. |
| Initiative group II | Experimental | Other: manual perineal massageDuring the active phase of labor, manual perineal massage will be performed with an interval of one hour. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrumental perineal massageIn the active phase of labor, perineal massage will be performed with an instrument twice with an interval of one hour. | Other | Initiative group I |
| manual perineal massageIn the active phase of labor, manual perineal massage is performed twice an hour apart. | Other | Initiative group II |
Primary outcome
Labor Evaluation Form Part I
Time frame: 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.
I. It will be applied in the latent phase of labor (cervical dilatation: 0-4 cm). II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm). III.Until two days after birth
Visual analog scale
Time frame: 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.
Birth pain. VAS is a horizontal or vertical line of 10 cm/100 mm that starts with "No pain" and ends with "Unbearable pain." No pain is written on one end and very severe or unbearable pain is written on the other end on the scale during the measurement and the patient marks their current state on this line. The length of the distance from no pain to the point marked by the patient indicates the patient's pain.
Labor Evaluation Form Part II
Time frame: 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.
It will be applied during the active period of labor (cervical dilatation: 5-8 cm). II.It will be applied in the active phase of labor (cervical dilatation: 4-8 cm). III.Until two days after birth
Labor Evaluation Form Part III
Time frame: This form is evaluated within 48 hours of postpartum
It will be applied within the first 48 hours after the birth is completed.
REEDA Scale
Time frame: The REEDA score is evaluated in the 48th hour after delivery.
This scale includes five factors that indicate perineal wound healing. These; These are redness (redness), edema (edema), ecchymosis (ecchymosis), discharge (discharge), approximation (approaching wound ends). Each factor takes values between 0-3. A total REEDA score (0-15) is obtained by evaluating these five improvement factors. The lowest score is 0 points, the highest score is 15 points. Higher scores indicate more tissue trauma.
Birth satisfaction scale
Time frame: This form is evaluated postpartum 10th day.
The original of the scale used to evaluate women's perceptions of birth satisfaction is 30 items and is a five-point Likert type. It consists of 3 main themes: quality of care, personal characteristics of women and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.
Visual analog scale
Time frame: The VAS is evaluated postpartum10th day.
It is a scale used to evaluate the severity of pain. participants are asked to mark or say the point on the line numbered from zero to 10 that corresponds to the pain.Zero points; While expressing no pain, 10 points indicates the most severe pain experienced.
3 secondary outcomes
Visual analog scale
Time frame: 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.
Visual analog scale
Time frame: The VAS is evaluated within 48 hours of postpartum after delivery
REEDA Scale
Time frame: The REEDA score is evaluated in the postpartum 10th day after delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 32399905Abdelhakim AM, Eldesouky E, Elmagd IA, Mohammed A, Farag EA, Mohammed AE, Hamam KM, Hussein AS, Ali AS, Keshta NHA, Hamza M, Samy A, Abdel-Latif AA. Antenatal perineal massage benefits in reducing perineal trauma and postpartum morbidities: a systematic review and meta-analysis of randomized controlled trials. Int Urogynecol J. 2020 Sep;31(9):1735-1745. doi: 10.1007/s00192-020-04302-8. Epub 2020 May 12.
- Background: PubMed 30115515Dencker A, Nilsson C, Begley C, Jangsten E, Mollberg M, Patel H, Wigert H, Hessman E, Sjoblom H, Sparud-Lundin C. Causes and outcomes in studies of fear of childbirth: A systematic review. Women Birth. 2019 Apr;32(2):99-111. doi: 10.1016/j.wombi.2018.07.004. Epub 2018 Aug 14.
- Background: PubMed 31341917Jahani Shoorab N, Mirteimouri M, Taghipour A, Latifnejad Roudsari R. Women's Experiences of Emotional Recovery from Childbirth-Related Perineal Trauma: A Qualitative Content Analysis. Int J Community Based Nurs Midwifery. 2019 Jul;7(3):181-191. doi: 10.30476/IJCBNM.2019.44993.
- Background: PubMed 34231203O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
- Background: PubMed 30770967Manresa M, Pereda A, Bataller E, Terre-Rull C, Ismail KM, Webb SS. Incidence of perineal pain and dyspareunia following spontaneous vaginal birth: a systematic review and meta-analysis. Int Urogynecol J. 2019 Jun;30(6):853-868. doi: 10.1007/s00192-019-03894-0. Epub 2019 Feb 15.
- Background: PubMed 26981126Kavvadias T, Hoesli I. The EpiNo(R) Device: Efficacy, Tolerability, and Impact on Pelvic Floor-Implications for Future Research. Obstet Gynecol Int. 2016;2016:3818240. doi: 10.1155/2016/3818240. Epub 2016 Feb 14.
- Background: PubMed 21456488Martin CH, Fleming V. The birth satisfaction scale. Int J Health Care Qual Assur. 2011;24(2):124-35. doi: 10.1108/09526861111105086.
- Background: PubMed 28379837Demsar K, Svetina M, Verdenik I, Tul N, Blickstein I, Globevnik Velikonja V. Tokophobia (fear of childbirth): prevalence and risk factors. J Perinat Med. 2018 Feb 23;46(2):151-154. doi: 10.1515/jpm-2016-0282.
- Derived from this study: PubMed 39240370Metinoglu M, Beji NK. The Effect of Perineum Massage Applied With and Without an Instrument in the Active Phase of Labor Birth Outcomes: A Randomized Clinical Trial. Int Urogynecol J. 2024 Oct;35(10):1993-2002. doi: 10.1007/s00192-024-05901-5. Epub 2024 Sep 6.
- pubmed 32399905Link provided by the sponsor.
- pubmed 30115515Link provided by the sponsor.
- pubmed 31341917Link provided by the sponsor.
- pubmed 34231203Link provided by the sponsor.
- pubmed 30770967Link provided by the sponsor.
- pubmed 26981126Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryem Metinoğlu principal investigator
TNKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumental perineal massage and manual perineal massage in people with Labor, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor Evaluation Form Part I (time frame: 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05190913, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.