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Completed

NCT Number: NCT03670420

The Application of Honey on Perineal Sutures

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

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Key information

Conditions

Perineal Tear Burns Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, 1206, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical honey

Other

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

Primary outcomes

  1. Mean change between groups in perceived pain scores on the visual analog scale at day 1 post-partum

    Time frame: 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.

  2. Saint Antoine questionnaire to measure perceived pain at day 1 post-partum

    Time frame: 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.

  3. Mean change between groups in perceived pain scores on the visual analog scale at day 4 post-partum

    Time frame: 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.

  4. Saint Antoine questionnaire to measure perceived pain at day 4 post-partum

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2018
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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