Protocol summary

Study aim
The effect of foot reflexology on fatigue and anxiety postpartum in primiparous
Design
Available sampling method in similar health centers also be randomly selected will be done. A sample size of 35 cases was calculated for each group.
Settings and conduct
This study is a quasi-experimental trial that will be conducted in two groups of intervention and contro.Sampling in each center simultaneously until completion of samples it will continue every day except for Fridays.To avoid interference between research samples, health centers in intervention and control groups will be selected separately.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Be primiparous.Natural vaginal delivery without tool must be done.The infant to be term and healthy,singleton.Exclusive Breastfeeding.No chronic and acute disease.The absence of unexpected incidents in the last 3 months for a first-degree relative according to the referring.Earn 40 or higher scores from the Fatigue Questionnaire and having mild and moderate levels of anxiety.Visit between day 10 and maximum 15 days after childbirth.Whith out varicose veins leg,Infection,pain or injury in the lower legs, ankles or feet.Exclusion criteria: Unwillingness women to continuation of presence at research.Take special medication such as Anti-anxiety drugs and sedatives and sleeping.Unfollow the massage by mothers in the program for one session.Occurrence of any side effects during the intervention including tenderness of sensitive oil and touch sensitive mothers
Intervention groups
Foot reflexology for the intervention group will take time since the beginning of massage for both feet 30 minutes( every foot 15 minutes) per day for each person it will take 3 consecutive days. Control group will receive postpartum routine care , educational pamphlets will be given.
Main outcome variables
State anxiety ؛Trait anxiety؛ Fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110425006284N13
Registration date: 2018-12-31, 1397/10/10
Registration timing: retrospective

Last update: 2018-12-31, 1397/10/10
Update count: 0
Registration date
2018-12-31, 1397/10/10
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on fatigue and anxiety during post partum in primiparous.
Public title
The effect of foot reflexology on fatigue and anxiety.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be primiparous Natural vaginal delivery without tool must be done The infant to be term and healthy, singleton Exclusive breastfeeding No chronic and acute disease (diabetes,blood pressure,depression) The absence of unexpected incidents in the last 3 months for a first-degree relative according to the said referrer Earn 40 or higher scores from the Fatigue Questionnaire and having mild and moderate levels of anxiety Visit between day 10 and maximum 15 days after childbirth With out varicose veins leg,Infection,pain or injury in the lower legs, ankles or feet
Exclusion criteria:
Unwillingness women to continuation of presence at research Take special medication such as anti-anxiety drugs and sedatives and Sleeping Unfollow the massage by mothers in the program for one session Occurrence of any side effects during the intervention including tenderness of sensitive oil and touch sensitive mothers
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, lottery
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences Faculty of Nursing and Midwifery and Rehab
Street address
Nursing And Midwifery School , Nosrat St., District 6., Tehran., Tehran Province
City
Tehran
Province
Tehran
Postal code
کد پستی : 1419733171
Approval date
2017-12-25, 1396/10/04
Ethics committee reference number
کد اخلاق IR.TUMS.FNM.REC.1396.4070

Health conditions studied

1

Description of health condition studied
State anxiety
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis

2

Description of health condition studied
Trait anxiety
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis

3

Description of health condition studied
Fatigue
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis

Primary outcomes

1

Description
State anxiety
Timepoint
At the beginning of the study (before intervention)،After 3 consecutive sessions (ten minutes after the intervention) and one week after the end of the intervention
Method of measurement
Spielberger State-Trait Anxiety questionnaire

2

Description
Trait anxiety
Timepoint
At the beginning of the study (before intervention)،After 3 consecutive sessions (ten minutes after the intervention) and one week after the end of the intervention
Method of measurement
Spielberger State-Trait Anxiety questionnaire

3

Description
Fatigue
Timepoint
At the beginning of the study (before intervention)،After 3 consecutive sessions (ten minutes after the intervention) and one week after the end of the intervention
Method of measurement
Visual Fatigue Assessment Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After placing the patient in a proper position,firstly do heating techniques from the dominant person's feet.Then will be done massage from the dominant foot and at three points of the pituitary gland, the solar plexus and the spine. The Tonify technique use to stimulate the pituitary point and to stimulate the solar plexus point and the spine will be used with the Basic grip technique.Duration of the intervention since the beginning of massage for both feet 30 minutes( every foot 15 minutes) per day for each person it will take 3 consecutive days. Before intervention, after 3 consecutive sessions(ten minutes after the end of the intervention) and one week after the end of the intervention again the Spielberger test questionnaire and visual assessment of fatigue will be completed by the participants and educational pamphlets will be given.
Category
Behavior

2

Description
Control group: control group will receive postpartum routine care. fatigue and anxiety with Spielberger test questionnaire and visual assessment of fatigue will be measured. in the end, educational pamphlets will be given.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
South Tehran Health Center
Full name of responsible person
Shekoufeh.Maleki
Street address
No.2,Abbas Shafei Aleey,Taleghani Ave,Vesale Shirazi Ave,Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1417863181
Phone
+98 21 0069 6695
Email
malekishekoufeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Esmat Karimi
Street address
No23,Valiasr Avenue,Dameshgh Street,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1417863181
Phone
+98 21 3685 8163
Fax
Email
malekishekoufeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sekoufeh.Maleki
Position
MS Student in reprouductive health
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing And Midwifery School , Nosrat St., District 6., Tehran., Tehran Province
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 217171669221
Email
malekishekoufeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Modares Maryam
Position
Phd Medical education
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Nursing And Midwifery School , Nosrat St., District 6., Tehran., Tehran Province
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4312
Email
modarres@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shekoufeh.Maleki
Position
MS Student in reproductive health
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing And Midwifery School , Nosrat St., District 6., Tehran., Tehran Province
City
Tehran
Province
Tehran
Postal code
1345764418
Phone
+98 21 7171 6692
Email
malekishekoufeh@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
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
No - There is not a plan to make this available
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