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The Application of Honey on Perineal Sutures

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03670420
Enrollment
68
Registered
2018-09-13
Start date
2018-09-10
Completion date
2019-03-01
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Pain, Perineal Tear

Brief summary

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

Interventions

OTHERMedical honey

The investigators use Medihoney®, a medical honey released by the DermaSciences.

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partumDay 1A 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-partumDay 1Participants 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 4 post-partumDay 4A 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 4 post-partumDay 4Participants 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

MeasureTime frameDescription
Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1Day 1Women 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-partumDay 4A 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-partumDay 1A 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026