Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception

NCT ID: NCT05358236

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2022-04-22

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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Conditions

Episiotomy Wound; Wound Healing; Pain; Training, Toilet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Episiotomy Wound Care and Genital Hygiene Training

Intervention Type: 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

Standard of care (Control group)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Episiotomy 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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

Gonca Buran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gonca Buran, PhD

Role: PRINCIPAL_INVESTIGATOR

Uludag Üniversity

Seyhan Çankaya, Ass. Prof

Role: STUDY_CHAIR

Selcuk University

Locations

Gonca Buran

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2022/4

Identifier Type: -

Identifier Source: org_study_id