Comparison of the effect of reflexology of the solar plexus and H7 point network on anxiety and amniocentesis pain
Design
Clinical trial with a control group, single-blind, randomized,
Settings and conduct
The study lacks blindness, and pregnant women who go to the ultrasound office in Birjand City are randomly selected. mood Anxiety is measured at the beginning of the study immediately after and ten days after amniocentesis and Adjective anxiety is measured before and ten days after amniocentesis. pain is measured before and after amniocentesis.
Participants/Inclusion and exclusion criteria
Enter:
Gestational age from 15 to 18 week
The score obtained from the Dess 21 questionnaire (anxiety, depression and stress) must moderate and less
Do not have multiple pregnancies
Do not have amniocentesis experience
No medical problem
No obstetric complications
Before the study, do not undergo foot reflexology or acupressure at the relevant point
Expire:
No Abnormal findings in the foots and hands
The desire not to cooperate
The research unit did not intervene Two consecutive times or for three consecutive days.
Use of psychiatric medications during the intervention
unusual sensitivity in the sole of the foot
Try the needle for amniocentesis more than once.
Intervention groups
Intervention group 1: Foot reflexology in the solar plexus once 30 minutes before amniocentesis by the researcher for 20 minutes per foot 10 minutes. These units perform foot reflexology every day for 10 days as they were trained.
Intervention group2: The acupressure on the H7 spot on the side of the ulnar bone and the Pisiform bone in the transverse fold line of the wrist is performed separately by the researcher for 5 minutes each hand for 30 minutes before performing amniocentesis. These units perform foot reflexology every day for 10 days as they were trained.
Main outcome variables
Mood anxiety, adjective anxiety, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200401046914N1
Registration date:2020-04-17, 1399/01/29
Registration timing:prospective
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Mahla Salarfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 5793
Email address
salarfard.ma@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of foot solar plexus and H7 points reflexology on anxiety and pain amniocentesis
Public title
Comparison the effect of foot reflexology and hand Acupressure on anxiety and pain amniocentesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least Literacy for reading and writing
Gestational age from 15 to 18 week
Maternal body mass index in the range 18.5-30
The score obtained from the Dess 21 questionnaire (anxiety, depression and stress) must moderate and less
Not older than 38 years
No smoking
No active vaginal bleeding
Do not have multiple pregnancies
Do not have amniocentesis experience
No medical problem
No obstetric complications
Before the study, do not undergo foot reflexology or acupressure at the relevant point.
No history of mental disorders
No history of psychiatric drugs
No Abnormal findings in the foots and hands
Exclusion criteria:
The desire not to cooperate
The research unit did not intervene Two consecutive times or for three consecutive days.
Use of psychiatric medications during the intervention
Lack of unusual sensitivity in the sole of the foot
Try the needle for amniocentesis more than once.
Age
To 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery for each group from one bag, day of the person or couple from another bag for sampling time
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Moalem Street
City
Birjand
Province
South Khorasan
Postal code
9716813456
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
http://ethics.research.ac.ir/IR.BUMS.REC.1398.394
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety Mood of Amniocentesis
Timepoint
At the beginning of the study, immediately after amniocentesis and ten days after amniocentesis
Method of measurement
Spielberger Mood Anxiety Questionnaire
2
Description
Amniocentesis anxiety(Adjective)
Timepoint
At the beginning of the study, ten days after amniocentesis
Method of measurement
Spielberger Anxiety Questionnaire of Mode and adjective
3
Description
Pain of Amniocentesis
Timepoint
Before and after amniocentesis
Method of measurement
Numerical scale of pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Foot reflexology in the solar plexus once 30 minutes before amniocentesis by the researcher for 20 minutes per foot 10 minutes. These units perform foot reflexology every day for 10 days as they were trained.
Category
Treatment - Other
2
Description
Intervention group: The acupressure on the H7 spot on the side of the ulnar bone and the Pisiform bone in the transverse fold line of the wrist is performed separately by the researcher for 5 minutes each hand for 30 minutes before performing amniocentesis. These units perform foot reflexology every day for 10 days as they were trained.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ultrasound clinic
Full name of responsible person
Mahla Salarfard
Street address
Birjand School of Nursing and Midwifery, Moalem Street, Birjand City
City
Birjand
Province
South Khorasan
Postal code
9716813456
Phone
+98 56 3243 5793
Email
Salarfard.ma@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Deputy of Research and Technology, Third Floor of Education and Research Building ,University of Medical Sciences, Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mahla Salarfard
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Birjand School of Nursing and Midwifery, MoalemStreet, Birjand City
City
Birjand City
Province
South Khorasan
Postal code
9716813456
Phone
+98 56 3243 5793
Email
Salarfard.ma@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahla Salarfard
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Birjand School of Nursing and Midwifery, Moallem Street
City
Birjand
Province
South Khorasan
Postal code
9716813456
Phone
+98 56 3243 5793
Email
Salarfard.ma@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mahla Salarfard
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Birjand School of Nursing and Midwifery, Moalem Street, Birjand City
City
Birjand City
Province
South Khorasan
Postal code
9716813456
Phone
+98 56 3243 5793
Email
Salarfard.ma@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available