Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception

NCT05358236 | Completed

• 1 other identifier: 2022/4
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Episiotomy Wound; Wound Healing; Pain; Training, Toilet

Keywords

wound healing; Episiotomy; genital hygiene; postpartum care; REEDA scale

Outcome Measures

Primary Outcomes (3)

• Personal information form before intervention

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

  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.

  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.

  postpartum 1sth day (after birth first 24 hours)

Secondary Outcomes (4)

• Episiotomy Area Evaluation after intervention

  postpartum 5th day

• Episiotomy pain Evaluation after intervention

  postpartum 5th day

• Episiotomy Area Evaluation after intervention

  Postpartum 15th day

• Episiotomy pain Evaluation after intervention

  Postpartum 15th day

Study Arms (2)

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.

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

Interventions

Episiotomy Wound Care and Genital Hygiene Training OTHER

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

training + written and illustrated training brochure

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 years of age and older primiparous women, who have given vaginally on the due date (37-42 gestational weeks) and have a mediolateral episiotomy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Gonca Buran

Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gonca Buran, PhD

  Uludag Üniversity

  PRINCIPAL INVESTIGATOR

• Seyhan Çankaya, Ass. Prof

  Selcuk University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No intervention will be made by the responsible researcher. Thus, she will be blinded to the experimental and control groups. The training intervention and data collection process will be carried out by the co-researcher. It will also enter the data into the SPSS program as A and B groups. The analysis will be carried out by the researcher blinded to the groups. After the reporting process is completed, it will be announced to which groups A and B groups belong. Participants will also be blind to each other.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The research is an experimental study with parallel groups including randomized controlled, experimental, and control with educational intervention

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 3, 2022
• Study Start: March 3, 2022
• Primary Completion: April 20, 2022
• Study Completion: April 22, 2022
• Last Updated: July 20, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)