EpisiotomyNCT07487974
Active Oxygen and Negative Ion Sanitary Pads for Episiotomy Pain, Healing, and Postpartum Symptoms
A study testing Active Oxygen and Negative Ion Sanitary Pad and Standard Postpartum Sanitary Pad in people with Episiotomy and Episiotomy Wound, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy, Episiotomy Wound, Postpartum Complication
- What is being tested?
- Active Oxygen and Negative Ion Sanitary Pad and Standard Postpartum Sanitary Pad
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 28 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Episiotomy, Episiotomy Wound, Postpartum Complication, Postpartum Recovery, Primiparous Women
- Being tested
- Active Oxygen and Negative Ion Sanitary Pad, Standard Postpartum Sanitary Pad
- Keywords
- Episiotomy, Active oxygen, Negative ions, Pain, Postpartum, primigravida
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Oxygen and Negative Ion Sanitary PadOther
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.
Standard Postpartum Sanitary PadOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pad Group | Experimental | 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. Receives: Other: Active Oxygen and Negative Ion Sanitary Pad |
| Control Group | Active comparator | 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. Receives: Other: Standard Postpartum Sanitary Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Measurement Times: 24 hours after birth 3rd day postpartum 7rd day postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Nov 2025
- Primary completion28 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487974
- Sponsor's protocol ID
- KTO-EPIZYO-RCT-2025
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07487974
- Acronym / sponsor ID
- KTO-EPIZYO-RCT-2025
- Conditions
- Episiotomy, Episiotomy Wound, Postpartum Complication, Postpartum Recovery, Primiparous Women
- Keywords
- Episiotomy, Active oxygen, Negative ions, Pain, Postpartum, primigravida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pad Group | Experimental | Other: Active Oxygen and Negative Ion Sanitary PadParticipants 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. |
| Control Group | Active comparator | Other: Standard Postpartum Sanitary PadParticipants in this group will use standard postpartum sanitary pads during the early postpartum period following episiotomy. All participants will also receive routine postpartum care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Oxygen and Negative Ion Sanitary PadParticipants 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. | Other | Pad Group |
| Standard Postpartum Sanitary PadParticipants 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. | Other | Control Group |
Primary outcome
Episiotomy Pain Score
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Oxygen and Negative Ion Sanitary Pad and Standard Postpartum Sanitary Pad in people with Episiotomy and Episiotomy Wound, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episiotomy Pain Score (time frame: Measurements will be conducted at: • 24 hours postpartum • 3rd day postpartum • 7th day postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.