Effect of Perineal Cryotherapy on Episiotomy

September 20, 2025 updated by: Eman Ahmed Fadel, Mansoura University

Effect of Perineal Cryotherapy on Episiotomy- Associated Pain Among Postpartum Women

The present study aims to evaluate the effect of perineal cryotherapy on episiotomy- associated pain among postpartum women.

The study hypothesis: Post-partum women who apply perineal cryotherapy have lower level of episiotomy- associated pain than those who don't apply.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The present study included postpartum mothers who are in a good health immediately after giving delivery, having an episiotomy and a normal vaginal birth of a single, full term, healthy baby with normal weight and vertex presentation.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eman A. Fadel, Assist. prof
  • Phone Number: +2 01002934749
  • Email: e_a@mans.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postpartum mothers who are in a good health immediately after giving delivery.
  • Having an episiotomy and a normal vaginal birth.
  • Having a vaginal birth at full term.
  • The delivery of a healthy single fetus having normal weight and vertex presentation.

Exclusion Criteria:

  • Women who are experiencing labor or complications after giving birth, such as hemorrhage, a tear, or a cut in the perineum.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post-partum women who apply perineal cryotherapy after normal vaginal delivery with episiotomy
Apply perineal cryotherapy after normal vaginal delivery with episiotomy (interventional group)
Procedure: Cryotherapy
Cryotherapy is one of the non-pharmacological pain-relieving techniques, which involves chilling specific body areas with ice packs, ice cubes, ice water, or ethyl chloride sprays. The present study intervention will be conducted on 50 post-partum women to assist in relieve episiotomy pain. The researchers will assess the baseline level of episiotomy pain for each woman then the researchers will instruct women to perform perineal care. After cleaning the perineum, the researchers will ask the women to maintain her knee more flexed and apply ice gel pad against the episiotomy line for about 20 minutes then remove it and keep it in the freezer for reusing and assess the level of episiotomy pain using the Numeric Rating Scale for Pain after two hours from delivery. Ice gel pad will be applied for the second time after the episiotomy.
No Intervention: control group
Postpartum women who receive routine episiotomy care after normal delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of episiotomy-associated pain
Time Frame: from enrollmet until four hours after delivery
from enrollmet until four hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB. 0562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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