Acupuncture seems to offer an alternative treatment for insomnia. An increase in the serum concentration of melatonin is induced by acupuncture. Since this is usually lowered in pregnant women with sleeping difficulties, this may be one mechanism for the effect. Therefore the aim of this study was to survey the effects and safety of acupuncture on the treatment of insomnia during pregnancy.
Design
66 patients were randomly divided into 3 groups of 22, including: control group, sleep group and traditional medicine group.
Settings and conduct
The present study was designed as a prospective clinical trial which was was performed on 66 outpatients pregnant women who complain from insomnia who referred to Hafez and Hazrat zeinab hospitals shiraz University of medical sciences. Individuals in one group (n=22) received acupuncture therapy 20 min daily for 2 weeks (group acupuncture). On the other group (n=22), individuals received education of sleep hygiene (sleep hygiene group). Third group (n=22) was control group. The effect of interventions on to the quality and patterns of sleep were assessed at the end of 2 weeks of treatment using Pittsburgh sleep quality index.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age between 15-39, pregnant women 12-37, non-history of insomnia and mental disorders
Exclusion criteria: History of depression or insomnia, high risk pregnancy
Intervention groups
Individuals in one group (n=22) received acupuncture therapy 20 min daily for 2 weeks (group acupuncture). On the other group (n=22), individuals received education of sleep hygiene (sleep hygiene group). Third group (n=22) was control group. The effect of interventions on to the quality and patterns of sleep were assessed at the end of 2 weeks of treatment using Pittsburgh sleep quality index.
Main outcome variables
Comparison of the score of the Pittsburgh Sleep Disorders Questionnaire after the intervention was considered as the primary outcome of the study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140525017827N4
Registration date:2017-12-25, 1396/10/04
Registration timing:registered_while_recruiting
Last update:2017-12-25, 1396/10/04
Update count:0
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
Nasrin Asadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
asadin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Acupuncture and sleep hygiene on insomnia during pregnancy
Public title
Effect of Acupuncture and sleep hygiene on insomnia during pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with aged between 15-39years
.Gestational aged between 12 and 37weeks
Not having a history of insomnia and mental disorders
Exclusion criteria:
Age
From 15 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Actual sample size reached:
66
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2015-04-29, 1394/02/09
Ethics committee reference number
IR.SUMS.MED.REC.1394.01
Health conditions studied
1
Description of health condition studied
Nonorganic insomnia
ICD-10 code
F51.0
ICD-10 code description
maternal disorders predominantly related to pregnancy
Primary outcomes
1
Description
Comparison of the score of Pittsburgh Sleep Disorders Questionnaire after the intervention
Timepoint
Before and after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 22 patients received acupuncture therapy 20 min daily for 2 weeks
Category
Treatment - Other
2
Description
Control group: 22 patients received education of sleep hygiene for 2 weeks
Category
Behavior
3
Description
Control group: 22 patients are monitored for 2 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Zahra Khosravi
Street address
Shahid Chamran blvd, Hafez Clinic
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
z.khosravi1394@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Khosravi
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
z.khosravi1394@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Asadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
nasadi2012@yahoo.ca
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin asadi
Position
Assistatnt professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
nasadi2012@yahoo.ca
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
Yes - There is 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
Title and more details about the data/document
Completion of Ethic form
When the data will become available and for how long
After completing the project
To whom data/document is available
Patient or guardian
Under which criteria data/document could be used
Notice the result of the treatment
From where data/document is obtainable
Department of obstetrics and gynecology, Shahid Faghihi Hospital
What processes are involved for a request to access data/document