Active Oxygen and Negative Ion Sanitary Pads for Episiotomy Pain, Healing, and Postpartum Symptoms (NCT07487974) | Clinical Trial Compass
CompletedNot Applicable
Active Oxygen and Negative Ion Sanitary Pads for Episiotomy Pain, Healing, and Postpartum Symptoms
Turkey (Türkiye)66 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Episiotomy Pain Score
Timeframe: Measurements will be conducted at: • 24 hours postpartum • 3rd day postpartum • 7th day postpartum
2
Episiotomy Wound Healing Score
Timeframe: Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum
3
Postpartum Physical Symptom Severity
Timeframe: Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum