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CompletedNCT05358236Updated Jul 20, 2023

Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception

An interventional study of Episiotomy Wound Care and Genital Hygiene Training in Episiotomy Wound, Wound Healing and Pain, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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).

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Conditions studied

  • Episiotomy Wound
  • Wound Healing
  • Pain
  • Training, Toilet

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Keywords

  • wound healing
  • Episiotomy
  • genital hygiene
  • postpartum care
  • REEDA scale
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 128 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Other
    training + written and illustrated training brochure

    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.

    Other: Episiotomy Wound Care and Genital Hygiene Training

  • No intervention
    Standard of care (Control group)

    Standard of care (Control group) Left to the usual care of the hospital

Interventions

  • OtherEpisiotomy Wound Care and Genital Hygiene Training

    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

06

What researchers measure

Primary outcomes

  1. Personal information form before intervention

    Assessed using personal information. This instrument contains questions on women's sociodemographic and postpartum.

    Time frame: postpartum 1sth day (after birth first 24 hours)

  2. 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.

    Time frame: postpartum 1sth day (after birth first 24 hours)

  3. 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.

    Time frame: postpartum 1sth day (after birth first 24 hours)

Secondary outcomes

  1. 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.

    Time frame: postpartum 5th day

  2. 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.

    Time frame: postpartum 5th day

  3. 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.

    Time frame: Postpartum 15th day

  4. 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.

    Time frame: Postpartum 15th day

07

Study locations

1 site
  • Gonca Buran
    Bursa, 16059, Turkey
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References and documents

Individual participant data

Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Supporting information: Csr

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05358236
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Gonca Buran (Principal Investigator, Aydin Adnan Menderes University) — Principal investigator
First posted
May 3, 2022
Start date
Mar 3, 2022
Primary completion
Apr 20, 2022
Completion
Apr 22, 2022
Last update
Jul 20, 2023

Study contacts

Gonca Buran, PhD
principal investigator · Uludag Üniversity
Seyhan Çankaya, Ass. Prof
study chair · Selcuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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