Effect of Perineal Cryotherapy on Episiotomy

NCT06921200 | Not Yet Recruiting DMC

• 1 other identifier: IRB. 0562
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Normal Vaginal Delivery; Perineal Episiotomy

Keywords

Episiotomy; Pain; Perineal cryotherapy

Outcome Measures

Primary Outcomes (1)

• Level of episiotomy-associated pain

  from enrollmet until four hours after delivery

Study Arms (2)

Post-partum women who apply perineal cryotherapy after normal vaginal delivery with episiotomy

EXPERIMENTAL

Apply perineal cryotherapy after normal vaginal delivery with episiotomy (interventional group)

Procedure: Cryotherapy

control group

NO INTERVENTION

Postpartum women who receive routine episiotomy care after normal delivery

Interventions

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.

Post-partum women who apply perineal cryotherapy after normal vaginal delivery with episiotomy

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Pain

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Eman A. Fadel, Assist. prof

CONTACT

+2 01002934749; e_a@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Woman's Health and Midwifery Nursing

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: April 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-02