The Application of Honey on Perineal Sutures

NCT03670420 | Completed

• 1 other identifier: 2018-00995
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perineal Tear; Pain; Burns

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum

  Day 1

• Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1

  Day 1

• Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum

  Day 4

• Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at day 1

  Day 4

Study Arms (2)

Medical honey in addition to standard care

EXPERIMENTAL

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

Standard care

NO INTERVENTION

This group benefits from the standard care offered by the maternity: hygiene advice, analgesics, ice packs, buoys and positioning.

Interventions

Medical honey OTHER

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

Medical honey in addition to standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergic to honey and bees
• Drug use
• postpartum hemorrhage

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1206, Switzerland

Location

Related Publications (1)

• https://doi.org/10.1007/s11724-008-0083-6

  BACKGROUND

Related Links

• The psychometric caractéristiques of the Saint Antoine Questionnaire

MeSH Terms

Conditions

Pain; Burns

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 13, 2018
• Study Start: September 10, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 1, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

CH (1)