The effect of foot reflexology on happiness, spiritual well-being and academic stress in female university students resident in dormitory: A randomized clinical trial
The aim of this study would be investigated the effects of reflexology on academic stress, happiness and spiritual well-being
Design
Cases study are the available participants who are suitable considering to our inclusion criteria, will be divided into 3 groups: Intervention (reflexology), placebo (general message), control randomly. .The sample size will be 99 for the three groups.The blinding method is to prevent students from knowing in which group they are, before entering the room. Also no one of the intervention and placebo groups would know whether they have received reflexology or general message.
Settings and conduct
Reflexology for intervention group and general message for placebo group would be done. Message for each group would be done three time a week at the first week of study, twice a week at the second week of study, once a week at the third and fourth week of study. In total, message would be done seven times for each study case. Questionnaires would be filled up before intervention and after last intervention by the students (in the control group would be done after four weeks). The place of study would be in Kosar dormitory.
Participants/Inclusion and exclusion criteria
students who are studying in nursing (minimum : second semester, maximum: eight semester)
having healthy foot
not using of drugs which affect mental health considering to student' statements
The absence of specific stressful event in the past 6 months ( fill up the general stress questionnaire and get grade 27 and over
Intervention groups
Reflexology: 10 minutes of general massage and reflexology for each foot would be done.
general massage: duration of message on heel of foot would be 10 minutes for each foot in placebo group.
control: It would not be done any intervention in this group.
Main outcome variables
The effect of foot reflexology on happiness, spiritual well-being and academic stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110629006918N27
Registration date:2018-10-10, 1397/07/18
Registration timing:registered_while_recruiting
Last update:2018-10-10, 1397/07/18
Update count:0
Registration date
2018-10-10, 1397/07/18
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-02-08, 1397/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on happiness, spiritual well-being and academic stress in female university students resident in dormitory: A randomized clinical trial
Public title
Reflexology impact on happiness, spiritual well-being and academic stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
students who are studying in nursing (minimum : second semester, maximum: eight semester)
having healthy foot (without any wounds)
not using of drugs which affect mental health considering to student' statements
The absence of specific stressful event in the past 6 months ( fill up the general stress questionnaire and get grade 27 and over
Exclusion criteria:
to participate in similar studies and reflexology courses
pregnancy
to happen any problem about health of the foot during studying process
to happen any special stressful event during studying process such as disease, marriage, death of closed families and divorce
not willing to participate in studying
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
99
Actual sample size reached:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Cases study are the available participants who are suitable considering to our inclusion criteria, will be divided into 3 groups: Intervention (reflexology), placebo (general message), control randomly. Participants will be blocked randomly into 3 and 6 block. Then they will be assigned to groups of intervention, placebo and control. Blocking will be done by a person who is not involved in sampling then type of intervention will be written on the paper and will be put in opaque pockets which have been numbered. Participants will be assigned to 3 groups using random numbers of software randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding method is to prevent students from knowing in which group they are, before entering the room. Also no one of the intervention and placebo groups would know whether they have received reflexology or general message.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.tbzmed.rec.1397.278
Health conditions studied
1
Description of health condition studied
spiritual well-being
ICD-10 code
Z71.81
ICD-10 code description
Spiritual or religious counseling
2
Description of health condition studied
academic stress
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified
Primary outcomes
1
Description
academic stress
Timepoint
Measurements will be done at the first session and one month after the start of the study.
Method of measurement
questionnaire
2
Description
happiness
Timepoint
Measurements will be done at the first session and one month after the start of the study.
Method of measurement
questionnaire
3
Description
spiritual well-being
Timepoint
Measurements will be done at the first session and one month after the start of the study.
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the reflexology group, duration of message is 20 minutes for each person totally. Message of each foot would take 10 minutes. First 5 minutes would be general message of sole of the foot and second 5 minutes would be reflexology of areas which are related to stress.
Category
Behavior
2
Description
Intervention group: In placebo group, duration of message is 20 minutes for each person totally. General message of each foot would take 10 minutes. It would be done on the heal of foot.
Category
Prevention
3
Description
Control group: It would not be done any intervention in this group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar dormitory
Full name of responsible person
Fatemeh Parsa Mobaraki
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 51 3894 7979
Email
fatemeh.parsamobaraki@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Shariety South St ; Faculty of Nursing & Midwifery of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
"There is no further
Phone
+98 41 3477 0648
Email
fatemeh.parsamobaraki@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fatemeh Parsa Mobaraki
Position
MSN
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tabriz, SHariety South St
City
tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3286 8881
Email
fatemeh.parsamobaraki@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alehe Seyyedrasooly
Position
Msn Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariety South St. Faculty of Nursing & Midwifery, Tabriz, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41147773779
Email
seyyedrasooly@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
fatemeh parsa mobaraki
Position
Msn student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariety South St. Faculty of Nursing & Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3286 8881
Email
fatemeh.parsamobaraki@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available