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NCT Number: NCT06921200

Effect of Perineal Cryotherapy on Episiotomy

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cryotherapy

Procedure

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.

Primary outcomes

  1. Level of episiotomy-associated pain

    Time frame: from enrollmet until four hours after delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Eman A. Fadel, Assist. prof

CONTACT

[email protected]

+2 01002934749

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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