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

K

KTO Karatay University

Status

Enrolling

Conditions

Episiotomy Wound
Episiotomy
Postpartum Complication
Postpartum Recovery
Primiparous Women

Treatments

Other: Standard Postpartum Sanitary Pad
Other: Active Oxygen and Negative Ion Sanitary Pad

Study type

Interventional

Funder types

Other

Identifiers

NCT07487974
KTO-EPIZYO-RCT-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 2 patient groups

Pad Group
Experimental group
Description:
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.
Treatment:
Other: Active Oxygen and Negative Ion Sanitary Pad
Control Group
Active Comparator group
Description:
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.
Treatment:
Other: Standard Postpartum Sanitary Pad

Trial contacts and locations

1

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Central trial contact

Fatma Bay, PhD, RN; Çiğdem İrey, MSc Student

Data sourced from clinicaltrials.gov

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