Episiotomy WoundNCT05358236
Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception
A study testing Episiotomy Wound Care and Genital Hygiene Training in people with Episiotomy Wound and Wound Healing, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The World Health Organization (WHO) and professional societies recommend restricted episiotomy instead of routine episiotomy. However, since the 1990s, there has been evidence of the risks of the procedure, and although routine use has no benefit, it is still widely used. 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 Wound, Wound Healing, Pain
- What is being tested?
- Episiotomy Wound Care and Genital Hygiene Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2022to 22 Apr 2022
- 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
- 18 years of age and older
- primiparous
- givingbirth vaginally on due date (37-42 gestational weeks)
- who have a healthy newborn,
- who have a mediolateral episiotomy,
- who do not have communication problems
- who can understand and speak Turkish were included in the research.
Who cannot join
- Givingbirth by cesarean section
- Having third and fourth-degree perineal tears,
- Having a history of diseases that prevent wound healing,
- Using certain drugs (eg, glucocorticoids, anticoagulants, chemotherapy, immunosuppressant, and radiotherapy),
- Having chronic systemic diseases (heart, kidney and lung diseases, coagulation disorder, immunodeficiency, connective tissue disorders, and diabetes),
- Having history of genital warts, symptomatic vaginitis,
- Having history of perineal reconstructive surgery, any postpartum complication (hemorrhage, puerperal infection, mastitis, thromboembolic disease or postpartum psychiatric disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Episiotomy Wound Care and Genital Hygiene Training on Episiotomy Wound Healing and Pain Perception: Randomized Controlled Trial
The World Health Organization (WHO) and professional societies recommend restricted episiotomy instead of routine episiotomy. However, since the 1990s, there has been evidence of the risks of the procedure, and although routine use has no benefit, it is still widely used. In this study, investigators aimed to determine the effect of episiotomy on the wound healing process and pain perception by providing episiotomy wound healing and genital hygiene training with training material created to raise awareness about wound care after episiotomy and to eliminate factors that delay the healing of episiotomy wound.
Read the detailed description
This study aimed to determine the effect of episiotomy wound care and genital hygiene training on episiotomy wound healing and pain perception.
Methods: In this study, investigators used a randomized controlled trial approach.
It was carried out in the postpartum service of the medical faculty hospital. 128 participants who underlap vaginal postpartum episiotomy were randomly assigned to the experimental and control group. The women who gave birth in the experimental group were given episiotomy wound care and genital hygiene training. The routine postpartum care was given to the participants who gave birth in the control group. The data were collected using the personal information form, the episiotomy area evaluation scale (REEDA score), and the Visual Analog Scale (VAS).
.
- Conditions
- Episiotomy Wound, Wound Healing, Pain, Training, Toilet
- Being tested
- Episiotomy Wound Care and Genital Hygiene Training
- Keywords
- wound healing, Episiotomy, genital hygiene, postpartum care, REEDA scale
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episiotomy Wound Care and Genital Hygiene TrainingOther
Episiotomy wound healing and genital hygiene training were given face-to-face by researchers to the mothers assigned to the training group. The trainings were given to each mother individually in their rooms. The total training lasted an average of one hour. At the end of the training, the mothers were given a written and illustrated training brochure.
Training content
- Primarily, external reproductive organs were shown to mothers through pictures.
- Urethra, Vagina, Anus, Perineum areas were mentioned.
- The definition of Episiotomy was made; and where and how it was applied was explained with visual materials. It was explained how to care for the episiotomy area to heal more rapid and healthier.
- Information was given on how to change their menstrual pads.
- Information was provided on what to look for when using underwear
- What to watch out while taking a bath:
- What to pay attention to in your stitch area
| Study group | Role | What they receive |
|---|---|---|
| training + written and illustrated training brochure | Other | Postpartum first day was given wound care and genital hygiene training (one hour).
At the end of the training, the mothers were given a written and illustrated training brochure. Receives: Other: Episiotomy Wound Care and Genital Hygiene Training |
| Standard of care (Control group) | No intervention | Standard of care (Control group) Left to the usual care of the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal information form before intervention
Assessed using personal information. This instrument contains questions on women's sociodemographic and postpartum.
Measured: postpartum 1sth day (after birth first 24 hours)
Episiotomy Area Evaluation before intervention
Assessed using the Episiotomy Area Evaluation Scale (REEDA SCORE) before intervention. This scale covers five factors indicating perineal wound healing: (1) Redness, (2) Edema, (3) Ecchymosis, (4) Discharge, and (5) Approximation. A total REEDA score is obtained by evaluating each category of these five recovery factors. The scale is evaluated by giving 0, 1, 2, and 3 points to each evaluation. The lowest score is 0 and the highest score is 15.
Measured: postpartum 1sth day (after birth first 24 hours)
Episiotomy pain Evaluation before intervention
The Visual Analogue Scale (VAS) scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.
Measured: postpartum 1sth day (after birth first 24 hours)
Secondary outcomes (4)
Episiotomy Area Evaluation after intervention
Assessed using the Episiotomy Area Evaluation Scale (REEDA SCORE) before intervention. This scale covers five factors indicating perineal wound healing: (1) Redness, (2) Edema, (3) Ecchymosis, (4) Discharge, and (5) Approximation. A total REEDA score is obtained by evaluating each category of these five recovery factors. The scale is evaluated by giving 0, 1, 2, and 3 points to each evaluation. The lowest score is 0 and the highest score is 15.
Measured: postpartum 5th day
Episiotomy pain Evaluation after intervention
The Visual Analogue Scale (VAS) scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.
Measured: postpartum 5th day
Episiotomy Area Evaluation after intervention
Assessed using the Episiotomy Area Evaluation Scale (REEDA SCORE) before intervention. This scale covers five factors indicating perineal wound healing: (1) Redness, (2) Edema, (3) Ecchymosis, (4) Discharge, and (5) Approximation. A total REEDA score is obtained by evaluating each category of these five recovery factors. The scale is evaluated by giving 0, 1, 2, and 3 points to each evaluation. The lowest score is 0 and the highest score is 15.
Measured: Postpartum 15th day
Episiotomy pain Evaluation after intervention
The Visual Analogue Scale (VAS) scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.
Measured: Postpartum 15th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start3 Mar 2022
- Primary completion20 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- The research is an experimental study with parallel groups including randomized controlled, experimental, and control with educational intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Buran, Aydin Adnan Menderes University
- Investigators
- Gonca Buran, PhD, Principal investigator, Uludag ÜniversitySeyhan Çankaya, Ass. Prof, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358236
- Sponsor's protocol ID
- 2022/4
- Status last verified
- May 2022
- First submitted
- 26 Apr 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Episiotomy Wound Care and Genital Hygiene Training on Episiotomy Wound Healing and Pain Perception: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05358236
- Acronym / sponsor ID
- 2022/4
- Conditions
- Episiotomy Wound, Wound Healing, Pain, Training, Toilet
- Keywords
- wound healing, Episiotomy, genital hygiene, postpartum care, REEDA scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 3 May 2022 (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.
The World Health Organization (WHO) and professional societies recommend restricted episiotomy instead of routine episiotomy. However, since the 1990s, there has been evidence of the risks of the procedure, and although routine use has no benefit, it is still widely used. In this study, investigators aimed to determine the effect of episiotomy on the wound healing process and pain perception by providing episiotomy wound healing and genital hygiene training with training material created to raise awareness about wound care after episiotomy and to eliminate factors that delay the healing of episiotomy wound.
Detailed description
This study aimed to determine the effect of episiotomy wound care and genital hygiene training on episiotomy wound healing and pain perception.
Methods: In this study, investigators used a randomized controlled trial approach.
It was carried out in the postpartum service of the medical faculty hospital. 128 participants who underlap vaginal postpartum episiotomy were randomly assigned to the experimental and control group. The women who gave birth in the experimental group were given episiotomy wound care and genital hygiene training. The routine postpartum care was given to the participants who gave birth in the control group. The data were collected using the personal information form, the episiotomy area evaluation scale (REEDA score), and the Visual Analog Scale (VAS).
.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The research is an experimental study with parallel groups including randomized controlled, experimental, and control with educational intervention
| Arm | Type | Receives |
|---|---|---|
| training + written and illustrated training brochure | Other | Other: Episiotomy Wound Care and Genital Hygiene TrainingPostpartum first day was given wound care and genital hygiene training (one hour). At the end of the training, the mothers were given a written and illustrated training brochure. |
| Standard of care (Control group) | No intervention | –Standard of care (Control group) Left to the usual care of the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age and older
- primiparous
- givingbirth vaginally on due date (37-42 gestational weeks)
- who have a healthy newborn,
- who have a mediolateral episiotomy,
Key exclusion criteria (7 listed)
- Givingbirth by cesarean section
- Having third and fourth-degree perineal tears,
- Having a history of diseases that prevent wound healing,
- Using certain drugs (eg, glucocorticoids, anticoagulants, chemotherapy, immunosuppressant, and radiotherapy),
- Having chronic systemic diseases (heart, kidney and lung diseases, coagulation disorder, immunodeficiency, connective tissue disorders, and diabetes),
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 |
|---|---|---|
| Episiotomy Wound Care and Genital Hygiene TrainingEpisiotomy wound healing and genital hygiene training were given face-to-face by researchers to the mothers assigned to the training group. The trainings were given to each mother individually in their rooms. The total training lasted an average of one hour. At the end of the training, the mothers were given a written and illustrated training brochure. Training content * Primarily, external reproductive organs were shown to mothers through pictures. * Urethra, Vagina, Anus, Perineum areas were mentioned. * The definition of Episiotomy was made; and where and how it was applied was explained with visual materials. It was explained how to care for the episiotomy area to heal more rapid and healthier. * Information was given on how to change their menstrual pads. * Information was provided on what to look for when using underwear * What to watch out while taking a bath: * What to pay attention to in your stitch area | Other | training + written and illustrated training brochure |
Primary outcome
Personal information form before intervention
Time frame: postpartum 1sth day (after birth first 24 hours)
Assessed using personal information. This instrument contains questions on women's sociodemographic and postpartum.
Episiotomy Area Evaluation before intervention
Time frame: postpartum 1sth day (after birth first 24 hours)
Assessed using the Episiotomy Area Evaluation Scale (REEDA SCORE) before intervention. This scale covers five factors indicating perineal wound healing: (1) Redness, (2) Edema, (3) Ecchymosis, (4) Discharge, and (5) Approximation. A total REEDA score is obtained by evaluating each category of these five recovery factors. The scale is evaluated by giving 0, 1, 2, and 3 points to each evaluation. The lowest score is 0 and the highest score is 15.
Episiotomy pain Evaluation before intervention
Time frame: postpartum 1sth day (after birth first 24 hours)
The Visual Analogue Scale (VAS) scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.
4 secondary outcomes
Episiotomy Area Evaluation after intervention
Time frame: postpartum 5th day
Episiotomy pain Evaluation after intervention
Time frame: postpartum 5th day
Episiotomy Area Evaluation after intervention
Time frame: Postpartum 15th day
Episiotomy pain Evaluation after intervention
Time frame: Postpartum 15th day
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 20 Jul 2023.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Related trials for Episiotomy Wound
Active, not recruitingObservational study
Novosyn® Quick in Patients Undergoing Episiotomy Closure
Episiotomy Wound
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Not yet recruiting
Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
Episiotomy, Platelet Rich Plasma (PRP)
Active, not recruiting
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
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.
Gonca Buran, PhD principal investigator
Uludag Üniversity
Seyhan Çankaya, Ass. Prof study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Episiotomy Wound Care and Genital Hygiene Training in people with Episiotomy Wound and Wound Healing, run by Aydin Adnan Menderes 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 7 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 20 Jul 2023. 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?
Personal information form before intervention (time frame: postpartum 1sth day (after birth first 24 hours)). 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 20 Jul 2023.