- PDF - View
- PDF - Download
- XML - View
- XML - Download
Protocol summary
- Study aim
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 vomitingplanned and normal pregnancygestational age under 20 weeksBeing literate
Exclusion criteria:
symptoms of Hyperemesis Gravidarum (weight loss, hydration therapy, intravenous drugs, and or hospitalization for treatment of NVP)molar or twin pregnancythreatened abortionbeing affected by any known medical condition that might manifest with nausea or vomitinghistory of recent psychological disorders which require referring to psychologist or psychiatrist or disastrous eventstaking 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)])
2
- Description
- applying dietary modification
- Timepoint
- after intervention
- Method of measurement
- Questionnaire (applying dietary modifications (yes, almost, no))
3
- Description
- satisfaction from treatment
- Timepoint
- after intervention
- Method of measurement
- Questionnaire (satisfaction from treatment (yes, almost, no))
Intervention groups
1
- Description
- Intervention group: Acupressure group received pressure on P6 with Sea-band button for 3 days
- Category
- Treatment - Devices
2
- Description
- Control group: applied Sea-band without pressure on P6
- Category
- Placebo
Recruitment centers
1
- Recruitment center
Name of recruitment center
Bakeri public healthcare center in Ardebil
Full name of responsible person
Giti Ozgoli
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
gitiozgoli2017@gmail.com
2
- Recruitment center
Name of recruitment center
Javid Mohseni public healthcare center in Ardebil
Full name of responsible person
Giti Ozgoli
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
gitiozgoli2017@gmail.com
3
- Recruitment center
Name of recruitment center
Jedi public healthcare center in Ardebil
Full name of responsible person
Giti Ozgoli
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
gitiozgoli2017@gmail.com
4
- Recruitment center
5
- Recruitment center
Name of recruitment center
Mirza Hoseini public healthcare center in Ardebil
Full name of responsible person
Giti Ozgoli
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street, Tehran, Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
gitiozgoli2017@gmail.com
6
- Recruitment center
Name of recruitment center
Akhari public healthcare center in Ardebil
Full name of responsible person
Giti Ozgoli
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
gitiozgoli2017@gmail.com
Sponsors / Funding sources
1
- Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Sedigh Mobarakabadi
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
sedighehsedigh@gmail.com
- Grant name
- Grant code / Reference number
- Is the source of funding the same sponsor organization/entity?
- Yes
- Title of funding source
- Shahid Beheshti University of Medical Sciences
- Proportion provided by this source
- 100
- Public or private sector
- Public
- Domestic or foreign origin
- Domestic
- Category of foreign source of funding
- empty
- Country of origin
- Type of organization providing the funding
- Academic
Person responsible for general inquiries
- Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Sedigh Mobarakabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery and Reproductive Health, School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sedighehsedigh@gmail.com
Person responsible for scientific inquiries
- Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Sedigh Mobarakabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Sedighehsedigh@gmail.com
Person responsible for updating data
- Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sedigheh sedigh mobarakabadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Niayesh Highway, Vali-asr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sedighehsedigh@gmail.com
Sharing plan
- Deidentified Individual Participant Data Set (IPD)
- No - There is not a plan to make this available
- Justification/reason for indecision/not sharing IPD
Some part our spss data dystroied
- Study Protocol
- No - There is not a plan to make this available
- Statistical Analysis Plan
- No - There is not a plan to make this available
- Informed Consent Form
- No - There is not a plan to make this available
- Clinical Study Report
- No - There is not a plan to make this available
- Analytic Code
- No - There is not a plan to make this available
- Data Dictionary
- Not applicable
