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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: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-9mhs8r
Date of registration: 22/05/2015
Prospective Registration: No
Primary sponsor: Faculdade de Enfermagem da Universidade Estadual de Campinas
Public title: Use of acupressure with breathing technique and relaxation for pain relief in labor
Scientific title: Acupressure associated with breathing technique and relaxation for pain relief during labor: a randomized clinical trial
Date of first enrolment: 09/01/2013
Target sample size:
Recruitment status: Recruitment completed
URL:  http://ensaiosclinicos.gov.br/rg/RBR-9mhs8r
Study type:  Intervention
Study design:  Clinical trial of treatment, factorial, randomized, controlled, single-blind, three-arm.  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name: Reginaldo Roque   Mafetoni
Address:  Rua Alexander Fleming, nº 101 - Cidade Universitária Zeferino Vaz 13.083-88 Campinas Brazil
Telephone: + 55 (19) 35219343
Email: mafetoni@unicamp.br
Affiliation:  Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM/UNICAMP
Name: Reginaldo Roque   Mafetoni
Address:  Rua Alexander Fleming, nº 101 - Cidade Universitária Zeferino Vaz 13.083-88 Campinas Brazil
Telephone: + 55 (19) 35219343
Email: mafetoni@unicamp.br
Affiliation:  Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM/UNICAMP
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Labor, Obstetric, Labor pain
C10.597.617.515
G08.686.785.760.769.326
Intervention(s)
D019050
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.
D000529
Other
Primary Outcome(s)
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.
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.
Secondary Outcome(s)
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.
Time of labor; cesarean delivery rate; Apgar in the first and fifth minute of the newborn; use of analgesics and analgesia.
Secondary ID(s)
Source(s) of Monetary Support
Faculdade de Enfermagem da Universidade Estadual de Campinas
Hospital da Mulher "Profº Drº José Aristodemo Pinotti" - CAISM - Universidade Estadual de Campinas
Secondary Sponsor(s)
Hospital da Mulher "Profº Drº José Aristodemo Pinotti" - CAISM - Universidade Estadual de Campinas
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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