Protocol summary
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Study aim
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To evaluate the effect of acupuncture on insomnia in pregnant women by the measuring urine melatonin before and after acupuncture, so that we can introduce effective method for treatment of insomnia in pregnancy
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Design
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72 subjects with sleep disorder will be assigned into 2 groups with Block randomization method, 36 patients will be treated by Acupuncture and sleep hygiene and 36 patients will be received only hygiene.
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Settings and conduct
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Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm. The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions. At the end of treatment again patients is ask to collect a night urine sample and also refuel sleep questionnaire and efficacy Acupuncture and sleep hygiene will be evaluated.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age between 20-45 years.
Gestational aged between 12 and 36 weeks
Women with Pittsburgh sleep quality index score more than 5.
Exclusion criteria:
Patients must not have suffered from insomnia before pregnancy.
Patients must not have been treated by acupuncture within the preceding year.
Patients must not have high risk pregnancy
Patient must not have been taking hypnotic drugs.
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Intervention groups
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72 subjects with sleep disorder will be assigned into 2 groups with Block randomization method, 36 patients will be treated by Acupuncture and sleep hygiene and 36 patients will be received only hygiene.
Before start of treatment the patients will be ask to collect a night urine sample at 23-24 pm.
The acupuncture treatment will be performed 3 times a week by an acupuncturist, making at least 10 sessions.
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Main outcome variables
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Finally, urinary melatonin levels are compared before and after acupuncture treatment and sleep hygiene and the effectiveness of this treatment is evaluated.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140525017827N3
Registration date:
2017-12-10, 1396/09/19
Registration timing:
prospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2017-12-10, 1396/09/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Shiraz University Of medical Science
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Expected recruitment start date
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2017-12-21, 1396/09/30
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Expected recruitment end date
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2018-08-23, 1397/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of KI-3. HT-7. ST-36. PC-6, anmian I, GB-20, DU-20 acupuncture on relieving insomnia in pregnant woman
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Public title
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The effect of acupuncture on insomnia in pregnancy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Women with aged between 20-45 years. Gestational aged between 12 and 36 weeks Women with Pittsburgh sleep quality index score more than 5. Exclusion criteria: Patients must not have suffered from insomnia before pregnancy. Patients must not have been treated by acupuncture within the preceding year. Patients must not have high risk pregnancy (multifetal pregnancy, threated abortion, preeclampsia, …) Patient must not have been taking hypnotic drugs
Exclusion criteria:
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Age
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From 20 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-07-20, 1396/04/29
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Ethics committee reference number
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IR.SUMS.MED.REC.1396.77
Health conditions studied
1
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Description of health condition studied
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Nonorganic insomnia
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ICD-10 code
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F51.0
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ICD-10 code description
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maternal disorders predominantly related to pregnancy
Primary outcomes
1
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Description
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Measurment of urine Melatonine
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Timepoint
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before and after treatment
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Method of measurement
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ELISA
Intervention groups
1
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Description
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10 sessions of 20 minutes acupuncture
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Category
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Treatment - Drugs
2
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Description
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Observe 14 health issues
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University Of medical Science
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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IPD: Information and research data
Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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IPD: 2018
Ethic form: 2018
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To whom data/document is available
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IPD: Researcher & Patient
Ethic form: Patient
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Under which criteria data/document could be used
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IPD:
Ethic form: Awareness of test results
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From where data/document is obtainable
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IPD: OB & Gyn ward Shiraz university of medical sciences
Ethic form: OB & Gyn ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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IPD: Vice chancellery
Ethic form: Vice chancellery
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Comments
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