Pain Clinical Trial
Official title:
The Application of Honey on Perineal Sutures: a Randomized Controlled Clinical Trial
Verified date | February 2020 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate the effect of honey on perineal tears or episiotomies pain associated or not with anterior vulvar tears after vaginal delivery.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva University Hospitals | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
https://doi.org/10.1007/s11724-008-0083-6
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 |
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