Active Oxygen and Negative Ion Sanitary Pads for Episiotomy Pain, Healing, and Postpartum Symptoms

Effects of Active Oxygen and Negative Ion Sanitary Pads on Episiotomy Pain, Healing, and Postpartum Physical Symptom Severity in Primiparous Women: A Randomized Controlled Trial

This study is to assess the impact of sanitary pads infused with active oxygen and negative ions on episiotomy pain, wound healing, and postpartum physical symptoms in primiparous women. Participants will be randomly allocated to either the intervention group, utilizing active oxygen and negative ion pads, or the control group, employing normal postpartum pads. The research will assess pain intensity, recovery advancement, and physical manifestations during the initial postpartum phase. The objective is to ascertain if the intervention offers supplementary advantages relative to usual care.

Study Overview

• Status: Completed
• Conditions: Episiotomy; Episiotomy Wound; Postpartum Complication; Postpartum Recovery; Primiparous Women
• Intervention / Treatment: Other: Active Oxygen and Negative Ion Sanitary Pad; Other: Standard Postpartum Sanitary Pad

Detailed Description

Episiotomy is a surgical incision made during vaginal birth to enlarge the vaginal opening and support delivery. Although it can help prevent complications during childbirth, many women experience pain, discomfort, difficulty sitting, and delayed wound healing after the procedure. In the postpartum period, appropriate hygiene and wound care are essential to reduce discomfort, prevent infection, and support the healing of the perineal area. The tissues around the vulva and vagina become more sensitive due to increased moisture and hormonal changes, making the choice of hygiene products particularly important.

Sanitary pads containing active oxygen and negative ions have recently been introduced as a new type of hygiene product. These components are believed to improve comfort, support wound healing, and reduce irritation. Although their clinical effects in the postpartum period have not yet been extensively studied, their potential benefits make them a promising option for women recovering from episiotomy.

This study aims to examine whether sanitary pads with active oxygen and negative ions can reduce episiotomy pain, support wound healing, and decrease postpartum physical symptoms in primiparous women. Participants will be randomly assigned to either the intervention group using these special pads or the control group using standard postpartum pads. The findings may contribute to determining whether these products offer additional advantages in the early postpartum recovery process.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Karaman, Turkey (Türkiye)
    • Eğitim ve Araştırma Hastanesi

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Women aged 18 years or older
• At least primary school education
• Gestational age between 37 and 42 weeks
• Single, live, vaginal birth
• Mediolateral episiotomy performed
• Hemoglobin level > 11 mg/dL
• Voluntary participation and ability to provide informed consent

Exclusion Criteria:

• History of high-risk pregnancy
• History of high-risk or complicated labor
• Use of operative vaginal delivery methods (forceps, vacuum, etc.)
• Presence of additional perineal lacerations, including 3rd-degree tears or anal sphincter injury
• Cephalopelvic disproportion
• Postpartum hemorrhage
• Newborn requiring NICU care
• Diagnosis of vaginal fungal infection or sexually transmitted infections (e.g., herpes simplex, HPV)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants in this group will use standard postpartum sanitary pads during the early postpartum period following episiotomy. All participants will also receive routine postpartum care.	Other: Standard Postpartum Sanitary Pad; Participants in the control group will use standard postpartum sanitary pads following episiotomy. Routine postpartum care will be provided to all participants. The control product does not contain active oxygen or negative ions.
Experimental: Pad Group; Participants in this group will use sanitary pads containing active oxygen and negative ions during the early postpartum period following episiotomy. All participants will also receive routine postpartum care.	Other: Active Oxygen and Negative Ion Sanitary Pad; Participants in the intervention group will use sanitary pads containing active oxygen and negative ions during the early postpartum period following episiotomy. The product is applied as a hygiene pad and is not classified as a drug or medical device. Routine postpartum care will be provided to all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episiotomy Pain Score	Episiotomy-related pain will be assessed using a 10-point Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.	Measurements will be conducted at: • 24 hours postpartum • 3rd day postpartum • 7th day postpartum
Episiotomy Wound Healing Score	Wound healing will be evaluated using the REEDA Scale (Redness, Edema, Ecchymosis, Discharge, Approximation). Each item is scored from 0 to 3, with a total score ranging from 0 to 15. Higher scores indicate poorer wound healing (greater tissue trauma).	Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum
Postpartum Physical Symptom Severity	Postpartum physical symptom severity will be measured using the Postpartum Physical Symptom Severity Scale. The scale consists of 18 items, each rated on a 4-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), with total scores ranging from 0 to 54. Higher scores indicate greater severity of postpartum physical symptoms.	Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum

Collaborators and Investigators

• Sponsor: KTO Karatay University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): May 9, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Postpartum; Episiotomy; primigravida; Active oxygen; Negative ions
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Inorganic Chemicals; Oxygen Compounds; Free Radicals; Reactive Oxygen Species
• Other Study ID Numbers: KTO-EPIZYO-RCT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to ethical restrictions, privacy protection regulations, and institutional policies. Only aggregated study results will be reported

Drug and device information, study documents

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