Episiotomy Wound Care, Episiotomy Wound Healing and Pain Perception

Sponsor

Aydin Adnan Menderes University (Other)

Overall Status

Completed

CT.gov ID

NCT05358236

Collaborator

(none)

128

Enrollment

Location

Arms

1.6

Actual Duration (Months)

77.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Episiotomy Wound Wound Healing Pain Training, Toilet	Other: Episiotomy Wound Care and Genital Hygiene Training	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

Double (Investigator, Outcomes 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.

Primary Purpose:

Supportive Care

Official Title:

The Effect of Episiotomy Wound Care and Genital Hygiene Training on Episiotomy Wound Healing and Pain Perception: Randomized Controlled Trial

Actual Study Start Date :

Mar 3, 2022

Actual Primary Completion Date :

Apr 20, 2022

Actual Study Completion Date :

Apr 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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
No Intervention: Standard of care No intervention. Left to the usual care of the hospital

Arm

Intervention/Treatment

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

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

No Intervention: Standard of care

No intervention. Left to the usual care of the hospital

Outcome Measures

Primary Outcome Measures

Personal information form before intervention [postpartum 1sth day (after birth first 24 hours)]
Assessed using personal information. This instrument contains questions on women's sociodemographic and postpartum.
Episiotomy Area Evaluation before intervention [postpartum 1sth day (after birth first 24 hours)]
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 [postpartum 1sth day (after birth first 24 hours)]
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 [postpartum 5th day]
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 [postpartum 5th day]
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 [Postpartum 15th day]
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 [Postpartum 15th day]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gonca Buran	Bursa		Turkey	16059

Sponsors and Collaborators

Aydin Adnan Menderes University

Investigators

Principal Investigator: Gonca Buran, PhD, Uludag Üniversity
Study Chair: Seyhan Çankaya, Ass. Prof, Selcuk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gonca Buran, Principal Investigator, Aydin Adnan Menderes University

ClinicalTrials.gov Identifier:

NCT05358236

Other Study ID Numbers:

2022/4

First Posted:

May 3, 2022

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gonca Buran, Principal Investigator, Aydin Adnan Menderes University

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of May 6, 2022