Definition of effect of foot massage with orange essence on grade pain and anxiety women under cesarean section.
Design
The study population include women under cesarean section who are referred to bahar hospital of Shahrood. Sample size is 80. Sampling will be carried out using sequential sampling method and assignment of research units will be performed to intervention and control groups by blocking method. pain and anxiety will be measured using the questionnaires. In intervention group, foot massage with orange essence will intervene. Then the variables are measured immediately after intervention and 60 minuet after the intervention, in both groups.
Settings and conduct
bahar hospital of Shahrood, The person collecting information before and after the intervention and analyzer are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nulliparous mothers with cesarean section; No Medical condition in mother; mothers with no tissue damage on their feet; using Spinal analgesia for cesarean section; have Gcs 15.
Exclusion criteria: mothers who have serious health disorder. mothers who have tissue damage on their feet.
Intervention groups
In the intervention group, foot massage with orange essence and the second group is also a control group and foot massage without orange essence will be performed in this group. Before the intervention (4 hour after receive initial dose sedative prevalent bakhsh), the information are collected using demographic characteristics form and vas visual criterion and
spielberger anxiety questionnaires. in intervention group massage with 10 till 15 cc orange essence 1.5 percent will be performed. Immediately after the intervention and 60 minuet after the intervention, pain and anxiety will be measured.
Main outcome variables
pain, anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181226042137N1
Registration date:2019-04-27, 1398/02/07
Registration timing:registered_while_recruiting
Last update:2019-04-27, 1398/02/07
Update count:0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Nastaran Norozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3238 0469
Email address
norozi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The examining of the effect of foot massage with orange essence on grade pain and anxiety women under cesarean section.
Public title
The examining of the effect of foot massage with orange essence on grade pain and anxiety women under cesarean section.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Nulliparous mothers with cesarean section;
mothers with the age of 20-45 years old;
mothers should be literate;
No Medical condition in mother (cardiac, respiratory, hepatic or neurologic);
mothers with no tissue damage on their feet;
using Spinal analgesia for caesarean section;
have Gcs 15.
Exclusion criteria:
mothers who have serious health disorder.
mothers who have a tissue damage on their feet.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize by quadrilateral blocking. The randomization sequence will be carried out secretly. That is, there are 20 envelopes packed in each A and B code. After obtaining informed consent and ascertaining that the person is participating in the study, the researcher will take the desired envelope in accordance with the order and will proceed according to the group recorded in the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Medical Sciences
Street address
Tehran street, 7 tir Square.
City
shahrood
Province
Semnan
Postal code
36147 73947
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.SHMU.REC.1397.194
Health conditions studied
1
Description of health condition studied
Cesarean
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before intervention; Instantly After intervention and 60 minute After intervention.
Method of measurement
VAS visual criterion
2
Description
anxiety
Timepoint
Before intervention; Instantly After intervention and 60 minute After intervention.
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group foot massage will be performed with 10 till 15 cc orange essence 1.5 percent with basic techniques from region ankle till toes each 5 minuet and altogether 10 minuet per researcher educated .
Category
Behavior
2
Description
Control group: in this group foot massage will be performed without orange essence with basic techniques from region ankle till toes each 5 minuet and altogether 10 minuet per researcher educated .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Shahrood
Full name of responsible person
Nastaran Norouzi
Street address
Tehran Street
City
Shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
nastarannorouzi96@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad hasan Emamian
Street address
Tehran Street
City
Shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Grant name
Vice chancellor of Research and technology of Shahroud University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Nastaran Norouzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technologist
Street address
Tehran Street
City
Shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
nastarannorouzi96@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh Mobaraki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technologist
Street address
Tehran Street
City
Shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
fatemehmobaraki96@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Nastaran Norouzi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical Technologist
Street address
Tehran Street
City
Shahrood
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
nastarannorouzi96@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