RecruitingNot ApplicableNCT07487974

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


Sponsor

KTO Karatay University

Enrollment

76 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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)

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Interventions

OTHERActive 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.

OTHERStandard 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.


Locations(1)

Eğitim ve Araştırma Hastanesi

Karaman, Turkey (Türkiye)

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NCT07487974


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