This study examines and compares the effect of P6 acupressure with Sea-band, and placebo with each other and control group on the severity and frequency of nausea and vomiting of pregnancy.
Design
Randomized, controlled clinical trial in which 75 pregnant women in 3 groups participated.
Settings and conduct
This study was carried out on pregnant women who received prenatal care in five public healthcare centers in Ardebil (Iran). The participants were allocated to three groups including acupressure group (n=25), placebo group (n=25), and control group (n=25).
Participants/Inclusion and exclusion criteria
Inclusion criteria: having mild to moderate nausea and/or vomiting; planned and normal pregnancy; gestational age under 20 weeks; being literate. Non inclusion criteria: symptoms of Hyperemesis Gravidarum; molar or twin pregnancy; threatened abortion; being affected by any known medical condition that might manifest with nausea or vomiting; any history of recent psychological disorders which require referring to psychologist or psychiatrist or disastrous events; taking medicine (emetic or antiemetic); smoking.
Intervention groups
In acupressure group, constant pressure was applied on P6 points by means of a wristband on both wrists for three days except while showering. Participants in the placebo group used a wristband with the same method as for acupressure group but without the pressure button. No additional intervention was done for control group. Recommendations about dietary modifications were given to all participants verbally and in written.
Main outcome variables
Nausea (frequency; duration; severity);
vomiting frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190205042624N1
Registration date:2019-03-03, 1397/12/12
Registration timing:retrospective
Last update:2019-03-03, 1397/12/12
Update count:0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
Sedigheh Sedigh Mobarakabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
sedighehsedigh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2006-04-17, 1385/01/28
Expected recruitment end date
2006-11-20, 1385/08/29
Actual recruitment start date
2006-04-17, 1385/01/28
Actual recruitment end date
2006-11-20, 1385/08/29
Trial completion date
2006-11-20, 1385/08/29
Scientific title
Effect of P6 acupressure on nausea and vomiting in pregnant women: A randomized controlled clinical trial
Public title
The effect of P6 Acupressure on nausea and vomiting of pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate nausea and/or vomiting
planned and normal pregnancy
gestational age under 20 weeks
Being literate
Exclusion criteria:
symptoms of Hyperemesis Gravidarum (weight loss, hydration therapy, intravenous drugs, and or hospitalization for treatment of NVP)
molar or twin pregnancy
threatened abortion
being affected by any known medical condition that might manifest with nausea or vomiting
history of recent psychological disorders which require referring to psychologist or psychiatrist or disastrous events
taking medicine (emetic or antiemetic)
smoking
Age
From 19 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants were randomly allocated to three groups, using Random Allocation Soft-ware
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Taleghani hospital; SHahid Arabi Ave, Yaman street; SHahid CHamran highway
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2018-03-18, 1396/12/27
Ethics committee reference number
IR.SBMU.PHNM.1396.959
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting of Pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea of Pregnancy
Timepoint
Twice a day (midday and at night before bed) during the three days of intervention period.
Method of measurement
Daily diaries form included frequency, duration (minute), and severity of nausea [scored from 0 (no nausea) to 4 (very severe nausea)] and frequency of vomiting
2
Description
Vomiting of Pregnancy
Timepoint
Twice a day (midday and at night before bed) during the three days of intervention period.
Method of measurement
Daily diaries form included frequency of vomiting
Secondary outcomes
1
Description
Overall rate of response to treatment for nausea and vomiting
Timepoint
after intervention
Method of measurement
Questionnaire (overall rate of response to treatment for nausea and vomiting separately [scored from 0 (significantly worse) to 4 (significantly better)])