Instrumental and Non-Instrumental Perineal Message and Childbirth

NCT05190913 | Completed

• 1 other identifier: TNKU-M.Metinoglu-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor

Keywords

Labor Pain; Episiotomy; birth satisfaction; birth

Outcome Measures

Primary Outcomes (7)

• Labor Evaluation Form Part I

  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

  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.

  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

  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.

  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.

  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.

  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.

  The VAS is evaluated postpartum10th day.

Secondary Outcomes (3)

• Visual analog scale

  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

  The VAS is evaluated within 48 hours of postpartum after delivery

• REEDA Scale

  The REEDA score is evaluated in the postpartum 10th day after delivery.

Study Arms (2)

Initiative group I

EXPERIMENTAL

In the active phase of labor, perineal massage will be performed with the device at an interval of one hour.

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.

Other: manual perineal massage

Interventions

Instrumental perineal massage OTHER

In the active phase of labor, perineal massage will be performed with an instrument twice with an interval of one hour.

Initiative group I

manual perineal massage OTHER

In the active phase of labor, manual perineal massage is performed twice an hour apart.

Initiative group II

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• th-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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Meryem Metinoğlu

Tekirdağ, Süleymanpaşa, 59030, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 32399905 BACKGROUND

• Dencker 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.

  PMID: 30115515 BACKGROUND

• Jahani 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.

  PMID: 31341917 BACKGROUND

• O'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.

  PMID: 34231203 BACKGROUND

• Manresa 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.

  PMID: 30770967 BACKGROUND

• Kavvadias 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.

  PMID: 26981126 BACKGROUND

• Martin CH, Fleming V. The birth satisfaction scale. Int J Health Care Qual Assur. 2011;24(2):124-35. doi: 10.1108/09526861111105086.

  PMID: 21456488 BACKGROUND

• Demsar 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.

  PMID: 28379837 BACKGROUND

Related Links

• pubmed 32399905
• pubmed 30115515
• pubmed 31341917
• pubmed 34231203
• pubmed 30770967
• pubmed 26981126
• pubmed 21456488
• pubmed 28379837
• random number generator
• Referenced article for Gpower

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Meryem Metinoğlu

  TNKU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the design of the study, single or double masking cannot be done.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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).

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: January 13, 2022
• Study Start: November 22, 2021
• Primary Completion: December 12, 2022
• Study Completion: July 13, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)