Protocol summary

Study aim
The effect of foot stroke massage on the quality of sleep in patients with chronic obstructive pulmonary disease
Design
This Study Is A Randomized Clinical Trial.The Sample Size For Research Is 18 Subjects In Each Group.The Samples Will Be Selected By Convenience And Purposeful Sampling; Then They Will Be Assigned To The Intervention And Control Groups By Quadrilateral Permutation Block Method.
Settings and conduct
The Present Study Will Be Performed On Patients With Chronic Obstructive Pulmonary Disease With Sleep Disorder Referring To The Clinic Of Allameh Bohlol Gonabadi Hospital.Patients In Intervention Group Will Receive Foot Massage As Stroke Massage For 5 Consecutive Sessions And 20 Minutes For Each Session For A Total Of Two Legs. The Control Group Will Receive Routine Care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Having Chronic Obstructive Pulmonary Disease Based On Internal Medicine Recognition 2-Having a Sleep Disorder , According To Pittsburg Ssleep Quality Questionnaire Score (Total Score Hhigher Than 5) Exclusion Criteria: 1-Non-Use Of Hypnotics And Anti-Anxiety Drugs 2-Lack 0f Respiratory Tract Infection
Intervention groups
Patients In Intervention Group Will Receive Foot Massage As Stroke Massage For 5 Consecutive Sessions And 20 Minutes For Each Session For A Total Of Two Legs. The Control Group Will Receive Routine Care.
Main outcome variables
Sleep Quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180116038400N1
Registration date: 2018-10-15, 1397/07/23
Registration timing: retrospective

Last update: 2018-10-15, 1397/07/23
Update count: 0
Registration date
2018-10-15, 1397/07/23
Registrant information
Name
Amin Nouroozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 6490
Email address
nouroozi.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Stroke Massage on the Quality of Sleep in Patients with Chronic Obstructive Pulmonary Disease
Public title
The Effect of Foot Stroke Massage on the Quality of Sleep in Patients with Chronic Obstructive Pulmonary Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having chronic obstructive pulmonary disease Age 30 to 60 years old Having healthy feet Ability to tolerate foot massage Having a sleep disorder, according to Pittsburg sleep quality questionnaire score (total score higher than 5)
Exclusion criteria:
specific disease (diabetes and stroke) use sleeping pills and anti-anxiety drugs infection of the respiratory system
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The Subjects Were Randomly Selected and Assigned to Two Groups of Intervention and Control by Using Permutational Blocks.
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 in Gonabad University of Medical Sciences
Street address
Research & Technology Dept, Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.GMU.REC.1397.001

Health conditions studied

1

Description of health condition studied
Patients With Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.9
ICD-10 code description
Chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
Sleep Quality
Timepoint
Before the Study (before the intervention) and Six Says After the Intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants In This Group, The Stroke Massage Will Receive 15 Minutes For Each Foot For Five Consecutive Days at 5:00 pm.
Category
Other

2

Description
Control group: Participants In This Group Will Receive only Routine cares
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Bohlol Gonabadi Hospital
Full name of responsible person
Amin Nouroozi
Street address
Bohlol Gonabadi Hospital, Vahdat Blvd, Sadi Street, Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
nouroozi.m@gmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Seyed Ali Sajjadi
Street address
Research & Technology Dept, Gonabad University of Medical Sciences, Asian Roads, Gonabad, Khorasan Razavi
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 0805
Email
sa_1344@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Amin Nouroozi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bohlol Gonabadi Hospital, Vahdat Blvd, Sadi Street, Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
nouroozi.m@gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amin Nouroozi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bohlol Gonabadi Hospital, Vahdat Blvd, Sadi Street, Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6828
Email
nouroozi.m@gmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Amin Nouroozi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bohlol Gonabadi Hospital, Vahdat Blvd, Sadi Street, Gonabad City
City
Gonabad
Province
Razavi Khorasan
Postal code
96981-48471
Phone
+98 51 5725 6490
Email
nouroozi.m@gmu.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
Not applicable
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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