Clinical trial NCT06005077: Perineal Massage and Warm Application in Labor
Official title: Evaluation of the Effect of Perineal Massage and Warm Application on Perineal Trauma, Pain and Birth Comfort in Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Injury
Pain
Labor
Keywords: Labor
Perineal massage
Perineal warm compress
Perineal Trauma
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the effect of perineal massage and warm compress application at first and second stage of labor on perineal trauma, pain and delivery comfort.

Detailed description: Perineal trauma is the damage caused by rupture, laceration or episiotomy during birth. Birth-related perineal trauma can lead to many short and long-term physical and psychological morbidities that affect the woman's life. Problems such as pain, bleeding and delay in the attachment of mother and newborn appear in the early postpartum period. In the following period problems such as prolapse, incontinence, sexual dysfunction and anxiety may be experienced.

This randomised controlled study was executed at a research hospital between May 2018 - September 2019. The sample of study is made consisted of three intervention groups and a control group of total 120 pregnant women by randomisation method. Perineal massage, perineal warm compress application, perineal massage and warm compress was done to the intervention groups respectively. Nothing was done to the control group. Perineal massage was given for 10 minutes, warm compress application was done 30 minutes three times when cervical dilatation 3-4 cm, 5-7 cm and 8-10 cm respectively. The data was collected by using Socio-Demographic and Obstetric Data Collection Form, First and Second Stage of Labor Stage Data Collection Form, Childbirth Comfort Scale, Newborn Data Collection Form, Perineal Trauma and Bleeding Monitorisation/ Measurement Form, Visual Analogue Scale, Birth Satisfaction Scale and Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form. When evaluating the data; number, percentage, mean, standard deviation, median, ANOVA Test, Tukey Test, Kruskal Wallis Test, Paired Sample T Test, Friedman Test, Ki-Square Test and Fisher's Exact was used.

Eligibility criteria: Inclusion Criteria:

* Primiparous
* 38"week of pregnancy
* Singleton pregnancy
* Cervical dilatation 3"cm
* Cephalic presentation

Exclusion Criteria:

* Chronic disease
* Presence of fetal macrosomia
* Presence of uterin surgery
* Presence of fetal anomaly

Primary outcomes:
measure: Socio-Demographic and Obstetric Data Collection Form
timeFrame: Baseline
measure: First and Second Stage of Labor Stage Data Collection Form
timeFrame: During procedure
measure: Childbirth Comfort Scale
timeFrame: During the procedure
measure: Birth Satisfaction Scale
timeFrame: In the first 1 hour after birth
measure: Perineal Trauma and Bleeding Monitorisation/Measurement Form
timeFrame: In the first 1 hour after birth
measure: Visual Analogue Scale
timeFrame: During procedure
measure: Birth Satisfaction Scale
timeFrame: In the first 1 hour after birth
measure: Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form
timeFrame: In the first 1 hour after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gamze Acavut
Study officials:
affiliation: Ankara Medipol University
name: Gamze Acavut
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ducarme G, Pizzoferrato AC, de Tayrac R, Schantz C, Thubert T, Le Ray C, Riethmuller D, Verspyck E, Gachon B, Pierre F, Artzner F, Jacquetin B, Fritel X. Perineal prevention and protection in obstetrics: CNGOF clinical practice guidelines. J Gynecol Obstet Hum Reprod. 2019 Sep;48(7):455-460. doi: 10.1016/j.jogoh.2018.12.002. Epub 2018 Dec 12.
citation: Fukami T, Koga H, Goto M, Ando M, Matsuoka S, Tohyama A, Yamamoto H, Nakamura S, Koyanagi T, To Y, Kondo H, Eguchi F, Tsujioka H. Incidence and risk factors for postpartum hemorrhage among transvaginal deliveries at a tertiary perinatal medical facility in Japan. PLoS One. 2019 Jan 9;14(1):e0208873. doi: 10.1371/journal.pone.0208873. eCollection 2019.
citation: Barasinski C, Debost-Legrand A, Lemery D, Vendittelli F. Practices during the active second stage of labor: A survey of French midwives. Midwifery. 2018 May;60:48-55. doi: 10.1016/j.midw.2018.02.001. Epub 2018 Feb 8.
citation: Difranco JT, Romano AM, Keen R. Care practice #5: spontaneous pushing in upright or gravity-neutral positions. J Perinat Educ. 2007 Summer;16(3):35-8. doi: 10.1624/105812407X217138.