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

Sponsor
Tribhuvan University, Nepal (Other)
Overall Status
Recruiting
CT.gov ID
NCT05955352
Collaborator
(none)
46
Enrollment
1
Location
1
Arm
6.3
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Perineal warm compression Technique
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
there are two groups randomly selected. intervention and control group, One group will be used perineal heat application and the control group will be received standardized care.there are two groups randomly selected. intervention and control group, One group will be used perineal heat application and the control group will be received standardized care.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes
Actual Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. level of pain intensity [15 minutes after application of warm compression]

      Pain intensity will be assessed using a Numerical Pain Rating Score after the application of warm compression on perineum during the second stage of labor.

    2. Perineal outcomes [1 hour after application of warm compression]

      Perineal outcomes will be assessed as the degree of tears during childbirth as an effect of perineal warm compression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tribhuvan University Teaching Hospital Kathmandu Bagmati Nepal 44600

    Sponsors and Collaborators

    • Tribhuvan University, Nepal

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Isabel Lawot, Lecturer, Tribhuvan University, Nepal
    ClinicalTrials.gov Identifier:
    NCT05955352
    Other Study ID Numbers:
    • TribhuvaU
    First Posted:
    Jul 21, 2023
    Last Update Posted:
    Jul 21, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Isabel Lawot, Lecturer, Tribhuvan University, Nepal
    perineal warm compression, Tear, Pain

    Study Results

    No Results Posted as of Jul 21, 2023