Protocol summary

Summary
The purpose of this study is to determine the Effect of reflexologies path way on anxiety of midwifery & nursing’s girl students. Inclusion criteria): a desire to participate in the study; students in the clinical course of Midwifery and Nursing; having healthy legs; not taking psychiatric drugs in a month ago; the lack of physical or mental diseases. Exclusion criteria: unwillingness to continue the study for any reason; pregnancy. In this randomized clinical trial, without blinding, will be done on 114 nursing and midwifery students of Tehran University of Medical Sciences,. The participants will be allocated into three groups (Intervention, placebo & control) using randomized sampling method. Intervention and placebo groups will walk for 20 minutes, (intervention group on reflexologies path way) and (placebo on flat ground), in both groups will perform on three consecutive days. The control group will not be performed. For assessment of anxiety Spielberger State-Trait Anxiety questionnaire will completed at baseline and 24 hours after the intervention, by the participants. The outcomes will State-Trait Anxiety.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060612440N5
Registration date: 2017-06-19, 1396/03/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Ziba Taghizade
Name of organization / entity
Tehran University of Medical Sciences school of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 4694
Email address
taghizad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Adak Tejarat Asia company
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of reflexologies path way on anxiety of midwifery & nursing’s girl students
Public title
The Effect of reflexologies path way on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a desire to participate in the study; students in the clinical course of Midwifery and Nursing; having healthy legs; not taking psychiatric drugs in a month ago; the lack of physical or mental diseases. Exclusion criteria: unwillingness to continue the study for any reason; pregnancy.
Age
From 18 years old to 28 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshvarz Blvd.
City
Tehran
Postal code
1419733141
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1661

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
f41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
state anxiety
Timepoint
baseline and , 24 hours after the intervention
Method of measurement
Spielberger State-Trait Anxiety questionnaire

2

Description
Trait anxiety
Timepoint
at baseline and , 24 hours after the intervention
Method of measurement
Spielberger State-Trait Anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The participants will be allocated into three groups (Intervention, placebo & control) using randomized sampling method. Intervention and placebo groups will walk for 20 minutes, (intervention group on reflexologies path way) and (placebo on flat ground), in both groups will perform on three consecutive days. The control group will not be performed. For assessment of anxiety Spielberger State-Trait Anxiety questionnaire will completed at baseline and 24 hours after the intervention, by the participants
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Nursing and Midwifery
Full name of responsible person
Leila Zakeri Rad
Street address
Nosrat St., Tohid Sq., 1419733171
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Adak Tejarat Asia company
Full name of responsible person
Javad Mazloumian
Street address
East Lale Street, banafshe alley,Number 52.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Adak Tejarat Asia company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Medical Sciences/ University of Tehran ( TUMS)
Full name of responsible person
Leila Zakeri Rad
Position
master student
Other areas of specialty/work
Street address
Ghods Avenue, Keshavarz Blvd.
City
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Fax
Email
tumspr@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Medical Sciences/ University of Tehran (TUMS)
Full name of responsible person
Ziba Taghizade
Position
PhD in Reproductive Health
Other areas of specialty/work
Street address
Ghods Avenue, Keshavarz Blvd.
City
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Fax
Email
tumspr@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical Sciences/ University of Tehran(TUMS)
Full name of responsible person
Leila Zakeri Rad
Position
master student
Other areas of specialty/work
Street address
Ghods Avenue, Keshavarz Blvd.
City
Tehran
Postal code
1419733141
Phone
+98 21 8893 3768
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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