The effect of foot reflexology massage on sleep quality of school-age children with chronic lung diseases admitted to selected hospitals affiliated to Tehran University of Medical Sciences in 1400
1. Determining the quality of sleep in school-age children with chronic lung diseases in selected hospitals affiliated to Tehran University of Medical Sciences in 1400
Design
The clinical trial has a control and intervention group and is a blind end. It is performed on 36 children with name and fibrocystic.
Settings and conduct
Foot reflexology massage for school-age children diagnosed with chronic lung disease will be admitted at hospitals affiliated to Tehran universities. children will be randomly divided into two groups of odd and even considering the last number of their case number. How to enter is voluntary and with the written consent of parents. sleep quality is evaluated first by the related questionnaire and then again after the massage is given. Performing non-invasive complementary medicine procedure in 3 sessions of 30 minutes.
Participants/Inclusion and exclusion criteria
Entry requirements:
The children studied did not have foot ulcers, foot fractures or foot surgery.
They are between 6-12 years old.
The children under study must be hospitalized in the desired hospitals.
No entry conditions:
Having diseases such as nephrotic syndrome, diabetic foot ulcers and leg edema, etc.
Hospitalized in wards other than the lung wards .
Intervention groups
This study examines the quality of sleep in school-age children with name and fibrocystic by performing reflective foot massage. The reflexology massage of the sole of the foot in this study is performed by performing a non-invasive complementary medicine procedure in 3 sessions of 30 minutes. foot Massage will be held in hospitals affiliated to Tehran universities, and then the quality of sleep will be assessed with a questionnaire. Massage is done every evening. Each foot is massaged 5 times. Massage with baby oil will be done .
Main outcome variables
quality of sleep with CSHQ
General information
Reason for update
Acronym
ماساژ بازتابی کف پا
IRCT registration information
IRCT registration number:IRCT20210722051954N1
Registration date:2021-11-09, 1400/08/18
Registration timing:retrospective
Last update:2021-11-09, 1400/08/18
Update count:0
Registration date
2021-11-09, 1400/08/18
Registrant information
Name
Elnaz Moghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3865 1750
Email address
el.moghani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on sleep quality of school-age children with chronic lung diseases admitted to selected hospitals affiliated to Tehran University of Medical Sciences in 1400
Public title
The effect of foot reflexology massage on sleep quality of school-age children with chronic lung diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The children did not have foot ulcers
The children were between the ages of 6-12.
The studied child had no history of foot surgery
Days and nights were intended for the child's parents
Exclusion criteria:
Occurrence of any situation for the patient and his active family member that necessitates interventional measures or has a clear effect on quality of life, such as physical, psychological, family and economic crisis
The presence of the patient and his active family member in another educational program related to the quality of the child's sleep (except for the routine program of the center)
Any underlying disease (other than the diseases considered in this study) that restricts the patient's breathing, such as injury, burn and chest dressing, chest fracture, and...
Any conditions that exclude the possibility of intervention (foot massage), including foot fractures, wounds and foot dressings and...
Children did not have other chronic diseases that prevent reflexology massage
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Random sampling is one of the statistical sampling methods in which people in the community have an equal chance of being selected. In this method, the required people or objects are randomly selected from the list of statistical population that has been numbered and prepared for this purpose. According to the law of probability, selected individuals must have the same characteristics as the community from which they were selected.
Children were assigned to the intervention and control groups using a random division method (for example, the last number of even files of the intervention group and the last number of individual files of the control group). For example, the file number is mentioned as 04-34-86, considering that the number 6 is even, then in the present study, it will be included in the intervention group, and vice versa.
Blinding (investigator's opinion)
Single blinded
Blinding description
The children in the control group and their families are unaware of the assignment of the study groups. Principles will be done for the intervention group according to the principles that the researcher has passed the relevant course.
How to do the work varies according to the pressure on the sole of the foot and is not recognizable to the children family.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Medical Sciences, Tehran
Street address
No11.ladan6 ave .vakil abad blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9179653968
Approval date
2021-07-29, 1400/05/07
Ethics committee reference number
IR .IAU.TMU.REC.1400.067
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
Asthma
2
Description of health condition studied
cystic fibrosis
ICD-10 code
E84
ICD-10 code description
Cystic fibrosis
Primary outcomes
1
Description
Sleep quality score in the sleep quality questionnaire
Timepoint
Before the intervention and Immediately after the intervention
Method of measurement
Sleep quality questionnaire called CHSQ
Secondary outcomes
empty
Intervention groups
1
Description
In this study, foot reflexology massage was performed by performing a non-invasive complementary medicine procedure in 3 sessions of 30 minutes. Every day, the evening of massage for school-age children diagnosed with chronic lung diseases is hospitalized in hospitals affiliated to Tehran universities. Each leg is massaged 5 times in each session.
Category
Rehabilitation
2
Description
Control group: foot massage without pressure on specific points
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar
Full name of responsible person
Elnaz Moghani
Street address
No 11.Ladan 6 Ave. Vakil Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9179653968
Phone
+98 51 3865 1750
Email
El.moghani@gmail.com
2
Recruitment center
Name of recruitment center
Mofid
Full name of responsible person
Elnaz Moghani
Street address
No 11.Ladan 6 Ave. Vakil Abad Blvd.
City
MASHHAD
Province
Razavi Khorasan
Postal code
9179653968
Phone
+98 51 3865 1750
Email
El.moghani@gmail.com
3
Recruitment center
Name of recruitment center
Bahrami
Full name of responsible person
Elnaz Moghani
Street address
No 11.Ladan 6 Ave. Vakil Abad Blvd.
City
MASHHAD
Province
Razavi Khorasan
Postal code
9179653968
Phone
+98 51 3865 1750
Email
El.moghani@gmail.com
4
Recruitment center
Name of recruitment center
Pediatric Medical Center
Full name of responsible person
Elnaz Moghani
Street address
No 11.Ladan 6 Ave. Vakil Abad Blvd.
City
MASHHAD
Province
Razavi Khorasan
Postal code
9179653968
Phone
+98 51 3865 1750
Email
El.moghani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Shirin Hejazi
Street address
Sattari Blvd. Islamic Azad University.
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
Fnm.eexam@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
20
Public or private sector
Private
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
Elnaz Moghani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No11.Ladadan 6 Ave. Vakil Abad Blvd
City
MASHHAD
Province
Razavi Khorasan
Postal code
9179653968
Phone
+98 51 3865 1750
Email
El.moghani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Moghani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No11.Ladan 6 Ave. Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9179653968
Phone
+98 51 3865 1750
Email
El.moghani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elnaz Moghani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No11.Ladan 6 Ave. Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9179653968
Phone
+98 51 3865 1750
Email
el.moghani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data includes the age of the participants and the type of disease and how it is performed and the reportable result.
When the data will become available and for how long
2021/11/19
To whom data/document is available
Nursing students and other related fields
Under which criteria data/document could be used
Related research
From where data/document is obtainable
send email to researcher or professor
What processes are involved for a request to access data/document
Submit the desired title of the researcher and state the field of study