The Application of Honey on Perineal Sutures

Study Overview
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Brief Summary
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Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.

Official Title
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The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial

Conditions
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Perineal Tear, Pain, Burns

Intervention / Treatment
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* Other: Medical honey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major women Giving birth vaginally in the maternity of Geneva university hospital First and second degree perineal tears or episiotomy French speaking women The day of the delivery Exclusion Criteria: Allergic to honey and bees Drug use postpartum hemorrhage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical honey in addition to standard care<br>In addition to the usual care provided by the maternity unit, women allocated to this group apply honey on first and second degree perineal tears, episiotomies and anterior vulvar tears twice a day for four days from randomization. | Other: Medical honey<br>* The investigators use Medihoney®, a medical honey released by the DermaSciences.<br>|
| No Intervention: Standard care<br>This group benefits from the standard care offered by the maternity: hygiene advice, analgesics, ice packs, buoys and positioning. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum | A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the no pain anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times. | Day 1 | 
| Saint Antoine questionnaire to measure perceived pain at day 1 post-partum | Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times. | Day 1 | 
| Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum | A Visual Analogue Scale (VAS) is used by women to evaluate perceived pain. The score is determined by measuring the distance (mm) on the 100 mm line between the no pain anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater pain intensity. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times. | Day 4 | 
| Saint Antoine questionnaire to measure perceived pain at day 4 post-partum | Participants complete the Saint Antoine questionnaire (1), a french version of the short form Mcgill pain questionnaire. Mcgill pain questionnaire can be used to evaluate a person experiencing significant pain. Women use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High. Pain is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times. | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum | A Visual Analogue Scale (VAS) is used to measure burning sentation. The score is determined by measuring the distance (mm) on the 100 mm line between the no burn anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater burn intensity. Burning sensation is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times. | Day 1 | 
| Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1 | Women included in the intervention group complete a five points Likert scale ( Not at all, Very few, Few, Satisfied, Very satisfied) to evaluate their satisfaction with the application of honey on their perineal sutures. Woman satisfaction about honey application is evaluate at two different times (day 1 and 4) in order to objectify changes between the two measurement times. | Day 1 | 
| Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum | A Visual Analogue Scale (VAS) is used to measure burning sentation. The score is determined by measuring the distance (mm) on the 100 mm line between the no burn anchor and the patient's mark, providing a range of scores from 0 to 100 mm. A higher score indicates greater burn intensity. Burning sensation is evaluate at two different times (day 1 and 4) in order to objectify changes between the two groups and at the two measurement times. | Day 4 | 
| Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1 | Women included in the intervention group complete a five points Likert scale ( Not at all, Very few, Few, Satisfied, Very satisfied) to evaluate their satisfaction with the application of honey on their perineal sutures. Woman satisfaction about honey application is evaluate at two different times (day 1 and 4) in order to objectify changes between the two measurement times. | Day 4 |