Episiotomy, Episiotomy Wound, Postpartum Complication, Postpartum Recovery, Primiparous Women
Conditions
Keywords
Episiotomy, Active oxygen, Negative ions, Pain, Postpartum, primigravida
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.
Detailed 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.
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.
Sponsors
KTO Karatay University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episiotomy Pain Score | Measurements will be conducted at: • 24 hours postpartum • 3rd day postpartum • 7th day postpartum | 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. |
| Episiotomy Wound Healing Score | Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum | 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). |
| Postpartum Physical Symptom Severity | Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed