The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes

The goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women. The main questions may reveal the pain intensity and the perineal outcome of the warm compress which might be helpful to the women during labor and related authority of the hospital.

The intervention with warm perineal compression will be done among primiparous mothes during second stage of labor

Study Overview

• Status: Completed
• Conditions: Pain; Labor; Perineal Tear; Heat Therapy
• Intervention / Treatment: Procedure: Perineal warm compression Technique

Detailed Description

Participants

• After full dilatation of the cervix, assign participants in a 1:1 ratio to the study and control groups randomly.
• Ask women to select one closed envelope containing a card with the group allocation (study or control groups)
• Provide usual care according to the unit protocol to all the women until the second stage of labor.
• Provide the participants of the study group with a warm perineal compress during the whole second stage of labor
• Provide usual care according to the unit protocol to the participants of control group during the whole second stage of labor.

The process of applying the warm perineal compress

• Fill a clean container with warm water (45-59°C)
• Soak a clean pad in the water, squeeze then place gently on the perineum during each uterine contraction.
• Maintain the temperature between 38-44°C during its application.
• Re-soak the pad in warm water between contractions, to maintain warmth and then reapply.
• Replace the water in the container every 15 minutes until delivery or if the temperature drop below 45°C

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Kathmandu, Bagmati, Nepal, 44600
      • Tribhuvan University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Low-risk pregnant mothers such as no hypertension, Headache, Bleeding Infection etc -

Exclusion Criteria: Pregnancy with any health problems such as Preeclampsia, Bleeding, Obstructed Labour, Cesarean section

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Procedural intervention and Control group with standard care; There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care	Procedure: Perineal warm compression Technique; There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care to asses the pain intensity and perineal tear; Other Names: Perineal heat therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineal outcomes	Perineal outcomes will be assessed as the degree of tears during childbirth as an effect of perineal warm compression	1 hour after application of warm compression
level of pain intensity	Pain intensity will be assessed using an NPRS after the application of warm compression on perineum during the second stage of labor and The scale ranges from 0 to 10, where 0 indicates no pain, and 10 represents the worst level of pain. In between these two extremes, words such as mild, moderate, severe, and very severe pain are assigned to each 2 cm distance on the line, respectively.	15 minutes after application of warm compression

Collaborators and Investigators

• Sponsor: Tribhuvan University, Nepal
• Investigators: Principal Investigator: Isabel Lawot, MN, Maharajgunj Nursing Campus, Tribhuvan University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: perineal warm compression, Tear, Pain
• Other Study ID Numbers: TribhuvaU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No