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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00014691 |
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Date of registration:
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02/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Auricular Acupuncture as Effective Pain Relief After Episiotomy: A Prospective Interventional Randomized Parallel Single-center Study
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Scientific title:
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Auricular Acupuncture as Effective Pain Relief After Episiotomy: A Prospective Interventional Randomized Parallel Single-center Study |
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Date of first enrolment:
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01/11/2016 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00014691 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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3
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Andro
Košec |
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Address:
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Vinogradska cesta 29
10000
Zagreb
Croatia |
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Telephone:
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+385989817156 |
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Email:
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andro.kosec@yahoo.com |
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Affiliation:
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Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice, Zagreb, Croatia |
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Name:
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Andro
Košec |
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Address:
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Vinogradska cesta 29
10000
Zagreb
Croatia |
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Telephone:
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+385989817156 |
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Email:
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andro.kosec@yahoo.com |
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Affiliation:
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Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice, Zagreb, Croatia |
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Key inclusion & exclusion criteria
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Inclusion criteria: The study included:
1. healthy pregnant women
2. over 18 years of age,
3. a minimum of 36 weeks gestation
4. that underwent mediolateral episiotomy during vaginal delivery.
Sixty patients were included in the study.
Exclusion criteria: 1. any previously recorded illness during pregnancy,
2. underage patients,
3. refusal to submit to acupuncture.
Age minimum:
18 Years
Age maximum:
None
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pelvic and perineal pain
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R10.2
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R10.2
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Intervention(s)
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Group 1: Patients undergoing mediolateral episiotomy during vaginal delivery treated with auricular acupuncture for episiotomy pain relief.
Group 2: Patients undergoing mediolateral episiotomy during vaginal delivery treated with peroral analgesic therapy only.
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Primary Outcome(s)
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Primary outcome measures were pain intensity (VAS score) immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity.
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Secondary Outcome(s)
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Secondary outcome measures were the need for analgesics, the amount of given analgesics, and the number of analgesic repetitions during the day.
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Source(s) of Monetary Support
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Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Center Sestre milosrdnice, Zagreb, Croatia
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Ethics review
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Status: Approved
Approval date: 15/10/2016
Contact:
Hospital Board of Ethics, University Hospital Center Sestre milosrdnice
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