Protocol summary

Summary
The aim of this study is to determine the efficacy of acupuncture on the quality of sleep and sleepiness of shift nurses who work in affiliated hospitals of Kermanshah University of Medical Sciences. Nurses who have sleep disorders divide to 3 randomly groups including acupressure group, sham points group and control group. In acupressure group, skin electrical stimulation is going to perform in 6 points (3 bilateral points) for each person in 10 sessions (each session is 5 minutes). In sham points group, skin electrical stimulation is going to perform in sham points and similar to acupressure group. In control group there isn't any intervention. After 10 sessions of intervention, quality of sleep and sleepiness of 3 groups of nurses are going to evaluate and compare by Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015021319508N2
Registration date: 2015-02-23, 1393/12/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Bahador Pyvan
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6345
Email address
pyvan@irhk.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-03-06, 1393/12/15
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of electrical stimulation of acupuncture on quality of sleep and sleepiness of shift nurses who work in affiliated hospitals of Kermanshah University of Medical Sciences
Public title
Efficacy of acupuncture on quality of sleep and sleepiness of shift nurses who work in affiliated hospitals of Kermanshah University of Medical Sciences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: at least 2 month work in night shift; have Pittsburgh sleep quality index ≥5; have Epworth Sleepiness Scale ≥9. Exclusion criteria: smoker nurses; pregnancy; use of sedative drugs.
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: 33
Randomization (investigator's opinion)
N/A
Randomization description
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
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Siroudi Blvd.
City
Kermanshah
Postal code
Approval date
2015-01-01, 1393/10/11
Ethics committee reference number
45254

Health conditions studied

1

Description of health condition studied
sleep disorder
ICD-10 code
G47
ICD-10 code description
Sleep disorders

Primary outcomes

1

Description
Degree of sleepiness
Timepoint
After 10 sessions of acupuncture
Method of measurement
Epworth Sleepiness Scale

2

Description
quality of sleep
Timepoint
After 10 sessions of acupuncture
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (acupressure points): Skin electrical stimulation is going to perform in 6 points (3 bilateral points) in acupressure points for each person in 10 sessions (each session is 5 minutes).
Category
Treatment - Other

2

Description
Intervention group (sham points): Skin electrical stimulation is going to perform in 6 points (3 bilateral points) in sham points for each person in 10 sessions (each session is 5 minutes).
Category
Treatment - Other

3

Description
Control group: No intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hosptal
Full name of responsible person
Bahador Pyvan
Street address
City
Kermanshah

2

Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Bahador Pyvan
Street address
City
Kermanshah

3

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Bahador Pyvan
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences, Shaheed Shiroudi Blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Bahador Pyvan
Position
Master of nursing
Other areas of specialty/work
Street address
Imam Reza hospital, Parastar Blvd.
City
Kermanshah
Postal code
Phone
+98 83 3837 0557
Fax
Email
pyvan@irhk.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Bahador Pyvan
Position
Master of nursing
Other areas of specialty/work
Street address
Imam Reza hospital, Parastar Blvd.
City
Kermanshah
Postal code
Phone
+98 83 3837 0557
Fax
Email
pyvan@irhk.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Erfan Zare
Position
Master of Clinical Chemistry
Other areas of specialty/work
Street address
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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