Perineal Massage and Warm Application in Labor

NCT06005077 | Completed DMC

• 1 other identifier: 2018/13
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Injury; Pain; Labor

Keywords

Labor; Perineal massage; Perineal warm compress; Perineal Trauma

Outcome Measures

Primary Outcomes (8)

• Socio-Demographic and Obstetric Data Collection Form

  The Socio-Demographic and Obstetric Data Form was used to determine the socio-demographic and obstetric characteristics of the participants. This form, created by the investigators, includes 15 questions on age, height, weight, education level, and gestational week of the pregnant women, the way pregnancy occured, and the health problems experienced during pregnancy.

  Baseline

• First and Second Stage of Labor Stage Data Collection Form

  The First and Second Stage of Labor Data Form and the Newborn Data Form were used to note down the applications performed on the pregnant woman during the first and second stages of labor and on the newborn after delivery. The form created by the investigators following the review of the literature consists of three parts. In the first part, there are questions regarding the applications such as dilatation, wiping, drugs used in the first stage, amniotomy, and bladder catheterization performed when the pregnant woman is admitted into the delivery room. In the second part, there are questions on the application of local anesthesia in the second stage of labor, protection of the perineum, and the type of pushing. The third part consists of questions regarding the height, weight and APGAR measurement of the newborn. This form includes 33 questions in total.

  During procedure

• Childbirth Comfort Scale

  The Childbirth Comfort Scale (CCS) is used to determine the comfort level at birth. This scale is a 5-point Likert type scale and consists of 14 items. Each item is rated between 1-5 (1: Strongly disagree, 2: Mostly disagree, 3: Partially agree, 4: Mostly agree, 5: Completely agree). The scale has a four-factor structure: physical, psychospiritual, social and environmental.

  During the procedure

• Birth Satisfaction Scale

  The Birth Satisfaction Scale (BSS) is used to evaluate birth satisfaction. This scale is a 5-point Likert-type scale and consists of 30 items. The three main themes of the scale are quality of care, personal characteristics of the women, and stress experienced during childbirth. A minimum of 30 and a maximum of 150 points can be obtained from the scale. Higher scores indicate higher levels of satisfaction.

  In the first 1 hour after birth

• Perineal Trauma and Bleeding Monitorisation/Measurement Form

  The Perineal Trauma, Postpartum Bleeding and Episiotomy Length Evaluation Form was used to record data on perineal trauma and amount of bleeding. The form, created by theinvestigators, consists of 13 questions evaluating conditions such as episiotomy, type of perineal trauma, location and degree of trauma, and postpartum bleeding.

  In the first 1 hour after birth

• Visual Analogue Scale

  The Visual Analog Scale (VAS) is a one-dimensional measurement tool used to show perceived pain and its severity. One end of the scale indicates "painlessness (0)" and the other end indicates "the most severe pain possible (10)" .

  During procedure

• Birth Satisfaction Scale

  The Newborn Characteristics Data Collection Form consists of 7 questions including the newborn's height, weight and APGAR assessment.

  In the first 1 hour after birth

• Perineal Massage and Perineal Warm Compress Application Satisfaction Evaluation Form

  This form was used to record the phases, periods and durations of perineal massage and perineal heat application, as well as to evaluate the satisfaction with the application. A visual scale graded from 0 to 10 was used in the satisfaction evaluation. It was rated as "0" not at all satisfied, "10" very satisfied.In addition, the participants were asked whether the application was beneficial, whether participants would prefer it when they gave birth again, and whether they would recommend it to others. It was created by the researcher and expert approval was obtained.

  In the first 1 hour after birth

Study Arms (4)

Control group

NO INTERVENTION

After the hospitalization procedures were completed, the pregnant women in the control group were informed and their written consents were obtained. No intervention was performed on these pregnant women other than routine hospital practices. Data collection forms were applied.

Perineal Massage

EXPERIMENTAL

While the pregnant woman was in the lithotomy position, massage was applied with two fingers and rhythmic U-shaped movements starting from the side walls 3-4 cm inside the vagina and towards the rectum. This implementation was done for 10 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm.

Other: Perineal Massage Group

Perineal Warm Compress Application

EXPERIMENTAL

Sterile compresses kept in hot water of 40 C were placed on the perineum. Compresses that cooled down and became dirty were changed every 5-8 minutes. This implementation was done for 30 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm.

Other: Perineal Warm Compress Application Group

Perineal Massage and Perineal Warm Compress Application

EXPERIMENTAL

When the cervical dilatation was 3-4 cm, 30 minutes of warm compress and 10 minutes of perineal massage were performed. These two methods were applied when the cervical dilatation was 5-7 cm and 8-10 cm as well.

Other: Perineal Massage Group; Other: Perineal Massage and Perineal Warm Compress Application Group

Interventions

Perineal Massage Group OTHER

While the pregnant woman was in the lithotomy position, massage was applied with two fingers and rhythmic U-shaped movements starting from the side walls 3-4 cm inside the vagina and towards the rectum. This implementation was done for 10 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm.

Perineal Massage; Perineal Massage and Perineal Warm Compress Application

Perineal Warm Compress Application Group OTHER

Sterile compresses kept in hot water of 40 C were placed on the perineum. Compresses that cooled down and became dirty were changed every 5-8 minutes. This implementation was done for 30 minutes in three stages according to cervical dilatation. It was applied when the cervical dilatation was 3-4 cm, 5-7 cm, and 8-10 cm.

Perineal Warm Compress Application

Perineal Massage and Perineal Warm Compress Application Group OTHER

When the cervical dilatation was 3-4 cm, 30 minutes of warm compress and 10 minutes of perineal massage were performed. These two methods were applied when the cervical dilatation was 5-7 cm and 8-10 cm as well .

Perineal Massage and Perineal Warm Compress Application

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only women who were going to give birth were included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Gamze Acavut

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30553051 BACKGROUND

• 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.

  PMID: 30625154 BACKGROUND

• 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.

  PMID: 29494852 BACKGROUND

• 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.

  PMID: 18566649 BACKGROUND

• Acavut G, Guvenc G, Karasahin KE. The Effectiveness of Massage and Warm Compresses on Perineal Trauma, Hemorrhage, Length of Episiotomy and Pain: A Randomized Controlled Trial. Z Geburtshilfe Neonatol. 2025 Nov 19. doi: 10.1055/a-2730-1313. Online ahead of print.

  PMID: 41260484 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Gamze Acavut

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patients and principle investigator knew which group they were assigned to. Only the outcome assessor didn't know which patient was assigned to which group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: August 22, 2023
• Study Start: May 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)