The Application of Honey on Perineal Sutures

Not Applicable

Completed

• Conditions: Pain; Perineal Tear; Burns
• Interventions: Other: Medical honey

• Registration Number: NCT03670420
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-04
• Study Start: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical honey in addition to standard care	Medical honey	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.

Primary Outcome Measures

Name	Time	Method
Saint Antoine questionnaire to measure perceived pain at day 4 post-partum	Day 4	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.
Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum	Day 1	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.
Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum	Day 4	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.
Saint Antoine questionnaire to measure perceived pain at day 1 post-partum	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1	Day 4	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.
Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum	Day 4	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.
Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum	Day 1	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.

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland