The Application of Honey on Perineal Sutures

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670420
• Other study ID #: 2018-00995
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Pain
• Perineal Tear

Intervention

Other:
• Medical honey
The investigators use Medihoney®, a medical honey released by the DermaSciences.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Mean change between groups in peceived burn scores on the visual analog scale at day 1 post-partum	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.	Day 1
Secondary	Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at 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.	Day 1
Secondary	Mean change between groups in peceived burn scores on the visual analog scale at day 4 post-partum	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.	Day 4
Secondary	Proportions between groups in a Likert scale to measure women satisfaction about honey application on perineal sutures at 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.	Day 4

External Links

•   The psychometric caractéristiques of the Saint Antoine Questionnaire