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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

Tracking Information
First Submitted Date  ICMJE September 4, 2018
First Posted Date  ICMJE September 13, 2018
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE September 10, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Pain assessment [ Time Frame: Day 1 and 4 ]
    We will use a Visual Analogue Scale (VAS), a measurement instrument, to measure pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10 cm 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. We want to evaluate pain at two different times in order to objectify differences between the two groups as well as at the two measurement times
  • Pain assessment [ Time Frame: Day 1 and 4 ]
    We will also use 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. The woman will use a Likert 5 points scale to assess words that describe their pain : Absent, Low, Moderate, High Extremely, High. We want to evaluate pain at two different times in order to objectify differences between the two groups as well as at the two measurement times.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • burn [ Time Frame: Day 1 and 4 ]
    We will use a Visual Analogue Scale (VAS) to measure burn. Using a ruler, the score is determined by measuring the distance (mm) on the 10 cm 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.
  • Woman satisfaction [ Time Frame: Day 1 and 4 ]
    We will use a Likert 5 points scale, a psychometric questionnaire used to respond to a statement about satisfaction : Not at all, Very few, Few, Satisfied, Very satisfied.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Application of Honey on Perineal Sutures
Official Title  ICMJE The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Perineal Tear
  • Pain
  • Burns
Intervention  ICMJE Other: Medical honey
The investigators use Medihoney®, a medical honey released by the DermaSciences.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Medical honey
  • No Intervention: Standard care
    This group benefits from the standard care offered by the maternity: hygiene advice, analgesics, ice packs, buoys and positioning.
Publications * https://doi.org/10.1007/s11724-008-0083-6

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2020)
68
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2018)
62
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03670420
Other Study ID Numbers  ICMJE 2018-00995
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marie-Julia GUITTIER, University Hospital, Geneva
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Geneva
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP