Effect of acupressure versus no acupressure on sleep quality in pregnant women in the third trimester of pregnancy with sleep disorder: a single-blind crossover randomized clinical trial
To assess the effect of acupressure versus no acupressure on sleep quality in pregnant women in the third trimester of pregnancy with sleep disorder
Design
This is a single-blind crossover randomized clinical trial, phase II, in which 56 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible 56 pregnant women in the third trimester of pregnancy who will refer to Health Centers of Hamadan City during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 35 years;
Pregnant women in the third trimester of pregnancy;
Unsuitable sleep quality based on Pittsburg criteria (score of 5 or more);
Singleton pregnancy
Exclusion criteria:
High-risk pregnancy;
A history of infertility;
Ulcer and skin problems;
Psychological disorder;
Cancer;
Advance cardiovascular disease;
Insulin-dependent diabetes mellitus;
A history of acupuncture or acupressure
Intervention groups
Intervention group: Applying pressure on Shen Man's true points on both hands for 2 minutes (5 minutes in every point and 2 minutes rest) three time a week for 3 weeks
Control group: Applying pressure on Shen Man's false points on both hands for 2 minutes (5 minutes in every point and 2 minutes rest) three time a week for 3 weeks
Main outcome variables
Primary outcome: Assessing the quality of sleep before intervention and 3 weeks after intervention using Pittsburg questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N241
Registration date:2018-10-12, 1397/07/20
Registration timing:prospective
Last update:2018-10-12, 1397/07/20
Update count:0
Registration date
2018-10-12, 1397/07/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure versus no acupressure on sleep quality in pregnant women in the third trimester of pregnancy with sleep disorder: a single-blind crossover randomized clinical trial
Public title
Effect of acupressure versus no acupressure on sleep quality in pregnant women in the third trimester of pregnancy with sleep disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years;
Pregnant women in the third trimester of pregnancy;
Unsuitable sleep quality based on Pittsburg criteria (score of 5 or more);
Singleton pregnancy
Exclusion criteria:
High-risk pregnancy;
A history of infertility;
Ulcer and skin problems;
Psychological disorder;
Cancer;
Advance cardiovascular disease;
Insulin dependent diabetes mellitus;
A history of acupuncture or acupressure
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the tossing coin
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be unaware of the true and false pressure point. Therefore, the trial will be run as a single-blind
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
1990-06-09, 1369/03/19
Ethics committee reference number
IR.UMSHA.REC.1397.164
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Assessing the quality of sleep
Timepoint
Before intervention and 3 weeks after intervention
Method of measurement
Using Pittsburg questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Applying pressure on Shen Man's true points on both hands for 2 minutes (5 minutes in every point and 2 minutes rest) three time a week for 3 weeks
Category
Treatment - Other
2
Description
Intervention group: Applying pressure on Shen Man's true points on both hands for 2 minutes (5 minutes in every point and 2 minutes rest) three time a week for 3 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Hamadan City
Full name of responsible person
Dr. Seyyedeh Zahra Masoomi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Zahramid2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyyedeh Zahra Masoomi
Position
Fertility Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Zahramid2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyyedeh Zahra Masoomi
Position
Fertility Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Zahramid2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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