Determination the effect of foot reflexology on anxiety and pain of amniocentesis in both intervention and control groups
Design
Randomized and 2 groups .no blind
Settings and conduct
The place to do reflexology is the ommolbanin of the hospital in Mashhad, 2 group,no blind
Participants/Inclusion and exclusion criteria
Research units with gestational age 18-15 weeks. No more than 38 years old. Cuts, burns, yeast infections, varicose veins, warts, compensating corns are not a kind of numbness in the foot;The research unit does not tend to cooperate during the study. The intervention did not complete two consecutive times or three interrupted sessions per week. Research unit has been used as a specific drug affecting mental medicine. The study is withdrawn.
Intervention groups
A total of twenty minutes per Dopa is done by the researcher. Mother in the lying situation back on the bed in a quiet room with enough light and a pillow under the foot to be comfortable, first a public massage for 2 minutes is done to prepare the legs, the purpose of the public massage, the surface touch massage, which has the same foreground movements to warm up the feet. By hand or carry out clear and conducting movements and under the foot with two hands, the foot turns outside and slips in the heel of massager. Then, a dedicated massage at the point of the solar plexus is a general reflexology for 7 minutes, at the end of a minute, a gentle move from top to bottom over the entire area of the back and sides of the foot with the help of the fingers of both hands and sixty.
Main outcome variables
Anxiety, Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190731044399N1
Registration date:2019-08-21, 1398/05/30
Registration timing:prospective
Last update:2019-08-21, 1398/05/30
Update count:0
Registration date
2019-08-21, 1398/05/30
Registrant information
Name
Marzie Samieean
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3290 0570
Email address
marziesamieean@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on anxiety and pain of amniocentesis
Public title
foot reflexology on anxiety and pain of amniocentesis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Research units with gestational age of 18-15 weeks
The mother suffers from horrible incidents over the past 6 months
No more than 38 years old
Do not have a midwife problem in the current pregnancy
Not a history of mental disorder
No genetic problem at family class1
Cuts, burns, yeast infections, varicose veins, warts, compensating corns are not a kind of numbness in the feet
Do not have a history of recurrent abortion (more than 3 consecutive miscarriages
Exclusion criteria:
Age
To 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects with inclusion criteria were entered into the study in an easy way. , The selection of weekdays for people is done accidentally, as if the lottery was taken to remove any number of bags, if the number was paired in the intervention group and if the person was in the control group.
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
•Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9777165535
Approval date
2019-08-05, 1398/05/14
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.042
Health conditions studied
1
Description of health condition studied
anxiety and pain
ICD-10 code
ICD-10 code description
CHAPTER V( Mental and behavioural disorders)F40-F48 Neurotic, stress-related and somatoform disordersF41 Other anxiety disordersF41.1 Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
STAI questionnair
Secondary outcomes
1
Description
Pain
Timepoint
After intervention
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention group:The foot reflexology on the solar plexus is one time thirty minutes before the amniocentesis done by the researcher for 20 minutes every 10-minute foot. Foot reflexology is done by pressure and massage of solar پلکسوس area (sunnet). To reduce the friction of a non-volatile oil drop, the baby's oil is used before starting the work. In this research, reflexology starts from the left foot, conducting the massage in every foot ten minutes, totaling twenty minutes per dopa by the researcher. Mother in the lying situation back on the bed in a quiet room with enough light and a pillow under the foot to be comfortable, first a public massage for 2 minutes is done to prepare the legs, the purpose of the public massage, the surface touch massage, which has the same foreground movements to warm up the feet. By hand or carry out clear and conducting movements and under the foot with two hands, the foot turns outside and slips in the heel of وهمجنین massager. Then, the private massage in the solar grid point is a general reflexology for 7 minutes, at the end of a minute, a gentle move from top to bottom over the entire area of the back and sides of the foot with the help of both hands and sixty
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ommolbanin Hospital
Full name of responsible person
Marzie Samieean
Street address
Faculty of Nursing Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9777165535
Phone
+98 56 3290 0570
Email
marziesamieean@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samieean Marzie
Street address
Faculty of Nursing Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9777165535
Phone
+98 56 3290 0570
Email
AbedianZ@mums.ac.ir
Grant name
Grant code / Reference number
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
Abedian Zahra
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9378191331
Phone
+98 51 3859 1511
Email
AbedianZ@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abedian Zahra
Position
Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9378191331
Phone
+98 51 3852 8511
Email
marziesamieean@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samieean Marzie
Position
Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9378191331
Phone
+98 51 3852 8511
Email
marziesamieean@yahoo.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