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Trial record 2 of 3 for:    guittier

The Application of Honey on Perineal Sutures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03670420
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Marie-Julia GUITTIER, 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.

Condition or disease Intervention/treatment Phase
Perineal Tear Pain Burns Other: Medical honey Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 1, 2019

Arm Intervention/treatment
Experimental: Medical honey in addition to standard care
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
The investigators use Medihoney®, a medical honey released by the DermaSciences.

No Intervention: Standard care
This group benefits from the standard care offered by the maternity: hygiene advice, analgesics, ice packs, buoys and positioning.



Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670420


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1206
Sponsors and Collaborators
University Hospital, Geneva
Additional Information:
Publications:
https://doi.org/10.1007/s11724-008-0083-6

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Responsible Party: Marie-Julia GUITTIER, Associate Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03670420    
Other Study ID Numbers: 2018-00995
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No