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

NCT07487974 | Completed

• 1 other identifier: KTO-EPIZYO-RCT-2025
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Episiotomy; Episiotomy Wound; Postpartum Complication; Postpartum Recovery; Primiparous Women

Keywords

Episiotomy; Active oxygen; Negative ions; Pain; Postpartum; primigravida

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Pad Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Active Oxygen and Negative Ion Sanitary Pad OTHER

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.

Pad Group

Standard Postpartum Sanitary Pad OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Eğitim ve Araştırma Hastanesi

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Reactive Oxygen Species

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Free Radicals; Inorganic Chemicals; Oxygen Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician conducting data analysis will be blinded to group assignments. Participants, care providers, and investigators will not be blinded due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel groups: an intervention group using sanitary pads with active oxygen and negative ions, and a control group using standard postpartum sanitary pads. Both groups will receive routine postpartum care, and outcomes will be compared between groups.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: March 23, 2026
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 9, 2026
• Last Updated: May 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)