Clinical trial NCT05358236: Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception
Official title: The Effect of Episiotomy Wound Care and Genital Hygiene Training on Episiotomy Wound Healing and Pain Perception: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episiotomy Wound
Wound Healing
Pain
Training, Toilet
Keywords: wound healing
Episiotomy
genital hygiene
postpartum care
REEDA scale
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is an experimental study with parallel groups including randomized controlled, experimental, and control with educational intervention
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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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Eligibility criteria: 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:

* 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)

Primary outcomes:
measure: Personal information form before intervention
timeFrame: postpartum 1sth day (after birth first 24 hours)
measure: Episiotomy Area Evaluation before intervention
timeFrame: postpartum 1sth day (after birth first 24 hours)
measure: Episiotomy pain Evaluation before intervention
timeFrame: postpartum 1sth day (after birth first 24 hours)
Secondary outcomes:
measure: Episiotomy Area Evaluation after intervention
timeFrame: postpartum 5th day
measure: Episiotomy pain Evaluation after intervention
timeFrame: postpartum 5th day
measure: Episiotomy Area Evaluation after intervention
timeFrame: Postpartum 15th day
measure: Episiotomy pain Evaluation after intervention
timeFrame: Postpartum 15th day
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Gonca Buran
Study officials:
affiliation: Uludag Üniversity
name: Gonca Buran, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Selcuk University
name: Seyhan Çankaya, Ass. Prof
role: STUDY_CHAIR
References: