Determining the effect of foot reflexology massage on sleep quality in nurses
Design
Clinical trial with control group with parallel, randomized, on 86 nurses, four-way permutation blocking method was used for randomization.
Settings and conduct
The location of the project is the Intensive Care Unit (ICU), Cardiac Care Unit (CCU) and the Emergency Department of Vasei, Heshmatie and Emdad Hospitals. After obtaining written consent, nurses who are eligible to enter the study using random assignment to two groups of control (not receiving foot reflex massage) and intervention (after a training session, receiving foot reflex massage for 12 sessions) are divided. First, the demographic information form is completed by the nurses and also before the intervention and five days after the intervention, the Pittsburgh Sleep Quality Questionnaire will be completed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Having a minimum age of 22 and a maximum of 60 years
Willingness to collaborate in research
Get a Pittsburgh questionnaire score greater than 5
Having healthy limbs
Do not take sleeping pills
No history of receiving reflective massage
Exclusion Criteria:
Suffering from psychological diseases
Alcohol and drug addiction
Having skin diseases
Pregnancy and lactation
Intervention groups
In the intervention group, during a training session, the method of using reflective massage is taught and to ensure, they are asked to perform the intervention once in the presence of the researcher and then reflective massage two days a week for 6 weeks (12 sessions in total). ) For 30 minutes (15 minutes for each leg) 30 minutes before bedtime. During this period, follow-up is done by phone to ensure accurate intervention. The control group will not receive any intervention during the study.
Main outcome variables
A sleep quality score based on the Pittsburgh Sleep Quality Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220222054100N1
Registration date:2022-03-02, 1400/12/11
Registration timing:prospective
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Mojgan Gholitabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8310
Email address
gholitabaromranim98@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of self-foot reflexology massage on sleep quality in nurses
Public title
Assessment the effect of self-foot reflexology massage on sleep quality in nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a minimum age of 22 and a maximum of 60 years
Willingness to collaborate in research
Get a Pittsburgh questionnaire score greater than 5
Having healthy limbs
Do not take sleeping pills
No history of receiving reflective massage
Exclusion criteria:
Suffering from psychological diseases
Alcohol and drug addiction
Having skin diseases
Pregnancy and lactation
Age
From 22 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available methods and will be placed in intervention and control groups using random allocation permutation blocks. The randomization method in this study is based on quadratic blocks. These blocks consist of 2 letters (A and B). The letter A will be considered for the intervention group and the letter B for the control group. The blocks will be selected randomly and blindfolded. Each block determines the order of entry into the intervention and control groups. Thus, twenty-two quadruple blocks are formed and within each block, two people are considered as intervention people and two people as control people, and thus they will be placed in intervention and control groups. For example, assuming the ABAB block is selected from the left hand, the first and third samples will be included in the intervention group, respectively, and the second and fourth samples will be included in the control group, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar university of medical sciences
Street address
No. 31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112- صندوق 31
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.MEDSAB.REC.1400.163
Health conditions studied
1
Description of health condition studied
Sleep quality of nurses
ICD-10 code
F51.2
ICD-10 code description
A lack of synchrony between the sleep-wake schedule and the desired sleep-wake schedule for the individual's environment, resulting in a complaint of either insomnia or hypersomnia
Primary outcomes
1
Description
Percentage of people whose sleep quality score is between 5 and 21.
Timepoint
Measurement of sleep quality score at the beginning of the study (before the intervention) and five days after the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Reflexology foot massage two days a week for 6 weeks (12 sessions in total) for 30 minutes (15 minutes for each leg) 30 minutes before bedtime, 5 minutes out of 15 minutes for general massage The sole of the foot and 10 minutes of massage are dedicated to the reflex points of the sole of the foot. In such a way that a constant and gentle pressure within the tolerance of each person with a slow speed and regular rhythm of 0.5 cm using the middle part of the first paragraph of the index and thumb fingers so that one third of the nail bed is white, in reflex points (point Apply to the pineal glands on the outside of the big toe, the point of the brain and the point of the solar plexus). The researcher has been taught the method of using reflective massage and the skill of performing massage and applying pressure in the desired location, and to ensure this, they are asked to perform the intervention once in the presence of the researcher.
Category
Treatment - Other
2
Description
Control group: The control group does not receive any intervention during the study and only during the study they are controlled and followed in terms of exclusion criteria and so on. Then, five days after the intervention, the Pittsburgh Sleep Quality Questionnaire will be completed by both groups and the sleep scores of the control and intervention groups will be determined.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Mojgan Gholitabar
Street address
Vasei Hospital, Tohid Shahr Blvd, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
waseehospital@medsab.ac.ir
2
Recruitment center
Name of recruitment center
Heshmatie Hospital
Full name of responsible person
Mojgan Gholitabar
Street address
Heshmatie Hospital, Asadabadi Street, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1665
Email
heshmatie@medsab.ac.ir
3
Recruitment center
Name of recruitment center
Emdad Shahid Doctor Behehshti Hospital
Full name of responsible person
Mojgan Gholitabar
Street address
Emdad Shahid Doctor Beheshti Hospital, Razi Street, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617748189
Phone
+98 51 4464 0115
Email
Emdad@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshteh Ghorat
Street address
Vice Chancellor for Research and Technology, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8310
Email
vcResearch@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mojgan Gholitabar
Position
Master student of Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8310
Email
mozhgan.gh15@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammadreza Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8310
Email
ghasemimr901@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mojgan Gholitabar
Position
Master student of Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.31,Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 8310
Email
mozhgan.gh15@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD