The Effect of Acupressure on sleep quality of nursing students in internship period
Design
This study is a randomized controlled clinical trial with parallel groups that is divided into 3 groups: acupressure (Shenmen point), placebo (false point), and control (routine care).
Settings and conduct
For the intervention in acupressure group, the place of intervention (Shenmen point) will be determined. The intervention will be done by the students themselves. Therefore, the students in the test group (acupressure at the Shenmen and placebo) will be adequately trained at the beginning of the study. For acupressure intervention, the wristbands is fastened on both the patient's right and left wrists so that the plastic button is placed on the point of intervention (Shenmen point). This will be done every night before going to bed for four weeks. In the placebo acupressure group, the same procedure applies except that a false point (the point opposite the shenmen point behind the hand) will be used instead of pressure on Shenmen point. The study location is Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Nursing students of Shahid Beheshti University of Medical Sciences; studying in 7th semester nursing (internship);no scars at the Shenmen and placebo (False Point); non-use sleep medication during the past month; no history of acupressure. Exclusion criteria: Carpal tunnel syndrome; BMI above 35; state and trait anxiety score over 60.
Intervention groups
The intervention groups consisted of two groups of acupressure at the Shenmen (HT7) and the placebo (False Point) that would place the acupressure wristband on the target points for one month each night before bedtime. In the control group, students does not receive any special intervention
Main outcome variables
Students' sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120109008665N11
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-08, 1399/01/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Acupressure on sleep quality of nursing students in internship period
Public title
The Effect of Acupressure on sleep quality of nursing students in internship period
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
nursing student of Shahid Beheshti University of Medical Sciences
studying in 7th semester of nursing (internship)
no history of neuropsychiatric illness leading to hospitalization or use of psychiatric drugs
no history of sleep disturbances in a recent month
no scars at the Shenmen and placebo point
non-use sleep medication during the past month
no history of acupressure
Exclusion criteria:
Carpal tunnel syndrome
Students engaged in student work
BMI above 35
State and trait anxiety score over 60
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Students will be randomly assigned to three groups of A:acupressure, B: placebo acupressure, and C: control using 90 sealed envelopes containing the letters A, B, and C equally. Students will select the envelope themselves.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SEMUMS.REC.1398.324
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
F51.8
ICD-10 code description
Other sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Sleep Quality
Timepoint
Baseline, 10, 20 days and end of study (day after the end of intervention)
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group (Acupressure) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. The wristband, which has a plastic button with a diameter of 0.7 cm, is closed for one month each night before going to bed on both the right and left wrists of the patient so that the plastic button is placed on the point of intervention (Shenmen or HT7 point). The pressure is applied to the extent that the student does not feel discomfort or pain in the wrist.
Category
Other
2
Description
Intervention group: In the second group (false acupressure) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. The wristband, which has a plastic button with a diameter of 0.7 cm, is closed for one month each night before going to bed on both the right and left wrists of the patient so that the plastic button is placed on opposite the point of intervention (false point). The pressure is applied to the extent that the student does not feel discomfort or pain in the wrist.
Category
Other
3
Description
Control group: In the third group (control) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. This group does not receive any special intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Residence of nursing students of Shahid Beheshti University of Medical Sciences (dormitory, private
Full name of responsible person
Hassan Babamohamadi
Street address
5 Kilometers of Damghan Road, Nursing and Midwifery Faculty, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4299
Email
babamohammady2007@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Web page address
http://rtvc.semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4299
Email
babamohammady2007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4299
Email
babamohammady2007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4299
Email
babamohammady2007@gmail.com
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