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Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception

Primary Purpose

Episiotomy Wound, Wound Healing, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Episiotomy Wound Care and Genital Hygiene Training
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Episiotomy Wound focused on measuring wound healing, Episiotomy, genital hygiene, postpartum care, REEDA scale

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Gonca Buran

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

training + written and illustrated training brochure

Standard of care (Control group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 26, 2022
Last Updated
July 19, 2023
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT05358236
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
April 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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). .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episiotomy Wound, Wound Healing, Pain, Training, Toilet
Keywords
wound healing, Episiotomy, genital hygiene, postpartum care, REEDA scale

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research is an experimental study with parallel groups including randomized controlled, experimental, and control with educational intervention
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
training + written and illustrated training brochure
Arm Type
Other
Arm Description
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.
Arm Title
Standard of care (Control group)
Arm Type
No Intervention
Arm Description
Standard of care (Control group) Left to the usual care of the hospital
Intervention Type
Other
Intervention Name(s)
Episiotomy Wound Care and Genital Hygiene Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Personal information form before intervention
Description
Assessed using personal information. This instrument contains questions on women's sociodemographic and postpartum.
Time Frame
postpartum 1sth day (after birth first 24 hours)
Title
Episiotomy Area Evaluation before intervention
Description
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)
Title
Episiotomy pain Evaluation before intervention
Description
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 Outcome Measure Information:
Title
Episiotomy Area Evaluation after intervention
Description
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
Title
Episiotomy pain Evaluation after intervention
Description
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
Title
Episiotomy Area Evaluation after intervention
Description
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
Title
Episiotomy pain Evaluation after intervention
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonca Buran, PhD
Organizational Affiliation
Uludag Üniversity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seyhan Çankaya, Ass. Prof
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
Facility Information:
Facility Name
Gonca Buran
City
Bursa
ZIP/Postal Code
16059
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

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Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception

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