An interventional study of Active Oxygen and Negative Ion Sanitary Pad and Standard Postpartum Sanitary Pad in Episiotomy, Episiotomy Wound and Postpartum Complication, sponsored by KTO Karatay University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by KTO Karatay University · Not applicable, Interventional, and Supportive care
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.
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.
2,216 studies on the registry are indexed under Pain; 915 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 1,901 interventional studies indexed under Pain.
Browse Pain studies →KTO Karatay University is the lead sponsor of 126 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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 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.
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.
Episiotomy Pain Score
Episiotomy-related pain will be assessed using a 10-point Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Time frame: 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).
Time frame: 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.
Time frame: Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum
Plan to share: No — 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
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
KTO Karatay University