Comparison the Effect of Solar plexus Reflexology and P6 Point Acupressure on the Severity of Nausea and Vomiting of Pregnancy
Design
A total of 135 pregnant women with nausea and vomiting will be selected and will be randomly assigned into 3 groups (acupressure P6, solar plexus reflexology, control). Randomization will be done using a block randomization method.
Rhodes questionnaire will be used to measure the intensity of nausea and vomiting during the 4 days of intervention.
Settings and conduct
135 pregnant women with nausea and vomiting were selected and assigned into tree interventions groups using a block randomization method. In addition to diet, acupressure and reflexology will be used in 4th-7th day.Rhodes index questionnaire is used to measure the intensity of nausea and vomiting during the 4 days of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18-35 years old؛ single pregnancy؛ first trimester of pregnancy ؛presence of moderate to severe nausea and vomiting؛ Normal electrolyte؛ willing to participate in the study.
Exclusion criteria:unwanted pregnancy; gastrointestinal diseases; cigarette smoking; presence of ketonuria.
Intervention groups
Intervention group 1: Reflexology is administered by a researcher, for 4 days. We will have one session every day that lasts nearly 20 minutes.
Intervention group 2: Pressure on P6 (acupressure) that is 3 Cun above the wrist fold between the long palmar and radius flexor muscle tendons on the palm of the hand.
Main outcome variables
nausea ؛ vomiting ؛ Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180412039276N1
Registration date:2018-06-24, 1397/04/03
Registration timing:registered_while_recruiting
Last update:2018-06-24, 1397/04/03
Update count:0
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
Fateme Asadollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3822 6371
Email address
fasadollahi8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-09, 1397/02/19
Expected recruitment end date
2018-08-10, 1397/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of Reflexology on solar plexus and pressure on the P6 (Neiguan) point on the severity of nausea and vomiting pregnancy
Public title
A comparison of the effect of Reflexology on solar plexus and pressure on the P6 (Neiguan) point on the severity of nausea and vomiting pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian and resident of Mashhad
Having at least reading and writing skills
Single intrauterine pregnancy
Gestational age less than 16 weeks based on LMP or first trimester ultrasonography
Nausea with or without vomiting at least for the past three days
The severity of nausea and vomiting should be mild or moderate based on the nausea and vomiting (PUQE ) questionnaire.
Exclusion criteria:
Use of herbal or chemical soothing nausea and vomiting drugs
The presence of a medical or obstetric condition in the current pregnancy
Pregnancy after infertility
Intent to terminate pregnancy
Extreme psychological problems
Having previous knowledge about complementary medicine
Inflammation, ulcers, swelling, fractures or skin lesions in the wrists and soles
History of hospitalization due to severe nausea and vomiting in pregnancy
use of herbal or chemical remedies
medical or obstetric disease in the current pregnancy
pregnancy after infertility
Intent to terminate pregnancy
severe mental problems
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 135 pregnant women with nausea and vomiting will be selected and assigned into three intervention groups using a block randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The Patient is not aware of being in the control or intervention group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Quraishi Building , Daneshgah Ave, Mashhad, Razavi Khorasan Province , Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Approval date
2018-04-06, 1397/01/17
Ethics committee reference number
IR.MUMS.REC.1397.7
Health conditions studied
1
Description of health condition studied
Nausea and vomiting during pregnancy
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
nausea and vomiting
Timepoint
3 days before intervention and 4 days after interventions.
Method of measurement
Rhodes index (questionnaire)
Secondary outcomes
1
Description
retch
Timepoint
3 days before intervention and 4 days after interventions.
Method of measurement
Rhodes index (questionnaire)
2
Description
Anxiety
Timepoint
3 days before intervention and 4 days after interventions.
Method of measurement
DASS 21 Index
Intervention groups
1
Description
Intervention group1 (The reflexology group): the patients were considered to put only on a diet in first three days. Then they received diet and foot reflexology on solar plexus on 4th-7th days. In this group, Daily reflexology was applied by researcher for 20 minutes.
Category
Treatment - Other
2
Description
Intervention group 2 (Acupressure Point P6) : the patients were considered to put only on a diet in first three days. Then they received diet and acupressure on 4th-7th days. In this group, sea band button was applied on the Neiguan point on both wrists for 4 days.
Category
Treatment - Devices
3
Description
Control group: The control group was considered to be only on the diet during 7 days.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad No. 1 Health Center
Full name of responsible person
Dr. Nasser Amini
Street address
Health Center No. 1 of Mashhad , next to Shahrbani Township, Vakil Abad Blvd , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3501 8011
Fax
Email
AminiN1@mums.ac.ir
Web page address
http://ch-mashhad1.mums.ac.ir/index.php
2
Recruitment center
Name of recruitment center
Mashhad No. 2 Health Center
Full name of responsible person
Dr. Ali Asghar Mahmoudi
Street address
Mashhad Health Center No. 2, Panjrah Paeen Kheyaban Ave , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9153913153
Phone
+98 51 3368 3000
Email
MahmoudiAA1@mums.ac.ir
Web page address
http://ch-mashhad2.mums.ac.ir
3
Recruitment center
Name of recruitment center
Mashhad No. 3 Health Center
Full name of responsible person
Dr. Brat Ali Arabnejad
Street address
Mashhad No. 3 Health Center, Payam Street ,Ershad 8 blvd,Khayyam blvd, Mashhsad ,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3763 4007
Email
arabnejadba1@mums.ac.ir
Web page address
http://behdasht3.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Qureishi building ,Daneshgah Ave ,Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
19091
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Asadollahi
Position
master of science student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 4, Sarafrazan 11 Blvd., Pirozi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 51 3822 6371
Email
Asadollahif9@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Rahele Babazade
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery , Ebne Sina ave,Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
BabazadehR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Asadollahi
Position
master of science student in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 4, Sarafrazan 11 Blvd., Pirozi Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177116763
Phone
+98 51 3822 6371
Email
Asadollahif9@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available