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The Effect of Foot bath on Sleep Quality in Elderly

Protocol summary

Study aim
To determine the effect of foot bath on elderly sleep quality
Design
Single-blinded Randomized Controlled Clinical trial on 45 elderly urban home residents, aged 60 or above, allocated in three groups (two intervention and one control group) will be recruited. Allocation will be done using permutation blocks randomization method.
Settings and conduct
The trial will be done in elders' house to assess the effect of foot bath on their sleep quality among three groups (two intervention and one control groups). Sleep quality will be evaluated using Pittsburgh Sleep Quality Index (questionnaire). Blinding will be achieved by using research assistant who is not informed of grouping and sleep quality scores, and assess the elders' sleep quality on 2nd and 4th week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60 or above, being relatively independent in activities of daily living, Ability to communicate, Lacking acute illness Exclusion criteria: Having night shift, Use of other supportive and complementary therapies, Diabetic over 10 years
Intervention groups
After training the elders in foot bath groups, they will be asked to immerse their feet 10 centimeters above the ankle, for 10 minutes in the 40ºC water (group 1), and 37ºC (group 2) for 2 weeks, every night, an hour before their usual sleeping time. To help subjects control water temperature, they will be given ink-marked thermometers. Control group will receive no intervention.
Main outcome variables
Subjects' sleep quality scores achieved by administering Pittsburgh Sleep Quality Index (questionnaire) at the beginning of the study; and on the 2nd and 4th week.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180405039197N1
Registration date: 2018-06-01, 1397/03/11
Registration timing: registered_while_recruiting

Last update: 2018-06-01, 1397/03/11
Update count: 0
Registration date
2018-06-01, 1397/03/11
Registrant information
Name
Zohreh Ebrahimzadeh moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7095
Email address
z.ebrahimzadeh@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-23, 1397/02/03
Expected recruitment end date
2018-08-25, 1397/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot bath on Sleep Quality in Elderly
Public title
Elderly Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 or over Being independent in activities of daily living Having a companion to help the elderly during intervention Ability to communicate (awareness of time, place, and people) Lacking acute illness
Exclusion criteria:
Having night shifts Use of other supportive and complementary therapies Diabetic more than 10 years Having peripheral vascular problems and neuropathies
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation will be done using permutation blocks randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects' sleep quality in all groups will be evaluated using Pittsburgh Sleep Quality Index (questionnaire) at the beginning of the study by the researcher; and at the 2nd and 4th week, by researcher's assistant who is blind to the grouping and sleep quality scores.
Placebo
Not used
Assignment
Parallel
Other design features
None

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd., Bojnurd
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Approval date
2018-03-13, 1396/12/22
Ethics committee reference number
IR.nkums.REC.1396.71

Health conditions studied

1

Description of health condition studied
Elders' Sleep Quality
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Elders' Sleep Quality Index Score
Timepoint
At the start, 14, and 28 days after intervention
Method of measurement
Pittsburgh Sleep Quality Index (Questionnaire)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Foot bath (immersing the feet 10 cm above ankle) using 40°C water, for 10 minutes, every night one hour before usual sleep time for 2 weeks.
Category
Other

2

Description
Intervention group 2: Foot bath (immersing the feet 10 cm above ankle) using 37°C water, for 10 minutes, every night one hour before usual sleep time for 2 weeks.
Category
Other

3

Description
Control group: Receives no intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
دانشگاه علوم پزشکی خراسان شمالی
Full name of responsible person
Mohammad Reza Armat
Street address
Bojnurd School of Nursing and Midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Fax
+98 58 3229 7095
Email
armat@nkums.ac.ir
Web page address
http://nurse.nkums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Kaveh Hojjat
Street address
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd.
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3222 1910
Fax
+98 58 3222 2122
Email
info@nkums.ac.ir
Web page address
http://nkums.ac.ir/
Grant name
1111
Grant code / Reference number
1111
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Zohreh Ebrahimzadeh Moghaddam
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bojnurd School of Nursing and Midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Fax
+98 58 3222 2122
Email
z.ebrahimzadeh@nkums.ac.ir
Web page address
http://nurse.nkums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mohammad Reza Armat
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bojnurd School of Nursing and Midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
94176-96786
Phone
+98 32297096
Fax
+98 58 3229 7095
Email
armat@nkums.ac.ir
Web page address
http://nkums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Zohreh Ebrahimzadeh Moghaddam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bojnurd School of Nursing and Midwifery, Shahriar St.
City
Bojnurd
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7096
Fax
+98 58 3229 7095
Email
z.ebrahimzadeh@nkums.ac.ir
Web page address
http://nurse.nkums.ac.ir/

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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