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. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-9mhs8r |
Date of registration:
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22/05/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Use of acupressure with breathing technique and relaxation for pain relief in labor
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Scientific title:
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Acupressure associated with breathing technique and relaxation for pain relief during labor: a randomized clinical trial |
Date of first enrolment:
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09/01/2013 |
Target sample size:
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Recruitment status: |
Recruitment completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-9mhs8r |
Study type:
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Intervention |
Study design:
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Clinical trial of treatment, factorial, randomized, controlled, single-blind, three-arm.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Reginaldo Roque
Mafetoni |
Address:
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Rua Alexander Fleming, nº 101 - Cidade Universitária Zeferino Vaz
13.083-88
Campinas
Brazil |
Telephone:
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+ 55 (19) 35219343 |
Email:
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mafetoni@unicamp.br |
Affiliation:
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Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM/UNICAMP |
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Name:
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Reginaldo Roque
Mafetoni |
Address:
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Rua Alexander Fleming, nº 101 - Cidade Universitária Zeferino Vaz
13.083-88
Campinas
Brazil |
Telephone:
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+ 55 (19) 35219343 |
Email:
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mafetoni@unicamp.br |
Affiliation:
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Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM/UNICAMP |
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Key inclusion & exclusion criteria
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Inclusion criteria: 156 women in labor; 37 weeks gestation or more; single and cephalic fetus; cervical dilation greater than or equal to 4 cm; two or more contractions in 10 minutes; skin integrates on acupressure point.
Exclusion criteria: Pregnant women with severe hypertensive disease; pregnancy bleeding; early indication of cesarean section; dilated cervix equal to or greater at 8 cm; analgesic drug use for less than 6 hours of admission in the study.
Age minimum:
Age maximum:
Gender:
F
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Health Condition(s) or Problem(s) studied
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Labor, Obstetric, Labor pain
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C10.597.617.515
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G08.686.785.760.769.326
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Intervention(s)
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D019050
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Experimental group: 52 women were instructed to perform during labor, slow and deep breathing during contractions, in between the contractions, release of all body muscles associated with slow thoracoabdominal breathing in a natural rhythm. This group applied pressure with the thumb of medium intensity (± 5kg to 15kg ) on the Sanyinjiao point (SP6) in both legs during the contractions, in a period of 20 minutes.
Placebo group: 52 women were instructed to perform during labor, slow and deep breathing during contractions, in between the contractions, release of all body muscles associated with slow thoracoabdominal breathing in a natural rhythm.This group was applied pressure with the thumb of low intensity (± 100g) with the thumb on the Sanyinjiao point (SP6) on both legs.
Control group: 52 women were instructed to perform during labor, slow and deep breathing during contractions, in between the contractions, release of all body muscles associated with slow thoracoabdominal breathing in a natural rhythm.
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D000529
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Other
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Primary Outcome(s)
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Pain control during labor according to the visual analog scale (VAS) graded from 0 to 10, 0 for complete absence of pain and 10 being the worst pain experienced, assessed before, 20 and 60 minutes of treatment.
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The average pain score was not different among the three groups at baseline (p=0.098). However, a difference was seen immediately after acupressure (SP6 5.92 ± 2.29 versus placebo 7.60 ± 2.47 versus control 8.50 ± 1.90, p<0.001) and at 60 minutes of treatment (SP6 6.47 ± 2.21 versus placebo 8.09 ± 2.25 versus control 8.75 ± 1.82, p<0.001). These differences were significantly different between groups.
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Secondary Outcome(s)
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The duration of labor was significantly different between the SP6 acupressure group [221.5 min (± 162.4 min)] versus placebo [397.9 min (± 265.6 min)] and versus control [381.9 min (± 358.3) min)] (p=0.005); the groups were similar regarding the cesarean section raterates (p=0.255); there was no difference between the Apgar scores in the first minute (p=0.954) and fifth minute (SP6 9.62 versus placebo 9.54 versus control 9.29, p=0.722); use of intravenous or intramuscular analgesic, epidural anesthesia or combined blockade showed no statistical difference (p=0.584) during study.
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Time of labor; cesarean delivery rate; Apgar in the first and fifth minute of the newborn; use of analgesics and analgesia.
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Source(s) of Monetary Support
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Faculdade de Enfermagem da Universidade Estadual de Campinas
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Hospital da Mulher "Profº Drº José Aristodemo Pinotti" - CAISM - Universidade Estadual de Campinas
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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