Determining the effect of auricular therapy on sleep quality in pregnant women with sleep disorders
Design
Clinical trial with two groups of control and intervention with parallel groups,one-blind, randomized strain on 104 patients.Use envelopes for randomization
will be.
Settings and conduct
This study will be performed in health centers affiliated to Tehran University of Medical Sciences.Intervention, performing ariculotherapy on the two groups of control and intervention will be that It is one-way blind (participants).
Participants/Inclusion and exclusion criteria
Inclusion criteria included:
Willingness to participate in the study, Score 6 or more on the Pittsburgh Questionnaire, Women in the third trimester of pregnancy and the absence of medical diseases and complications of pregnancy.
Exclusion criteria include:
Reluctance to continue participating in the study, Not attending all uriculotherapy sessions, not even one session; Not doing exercises regularly; Pregnancy complications such as preeclampsia and other pregnancy complications during the study; Delivery of the pregnant mother before completing four sessions of uriculotherapy
Intervention groups
The intervention is as follows In 3 parts of the right ear
(points: master shoulder/ lung1 and sleeping point), seed placed and these seeds are replaced every 7 days.The duration of the intervention period is 1 month and during this period, the seeds will be replaced 4 times. Women should press the seeds every 8 hours for 1 minutes. In the control group, instead of the seeds, only the seeds adhesives on the right ear (In 3 points of the throat, neck and sensory) women are placed.
Main outcome variables
sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210203050232N1
Registration date:2021-02-28, 1399/12/10
Registration timing:prospective
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
Roghayeh Ghadimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5554 7438
Email address
roghayehghadimi3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Auriculotherapy on Sleep quality in pregnant women with Sleep disorder
Public title
Auriculotherapy in Sleep disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Score 5 or more on the Pittsburgh Questionnaire
Women in the third trimester of pregnancy
Lack of medical diseases and pregnancy complications
Exclusion criteria:
Reluctance to participate in the study
Score less than 5 on the Pittsburgh Questionnaire
Women in the first and second trimesters of pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling by randomized block design of two treatments with quadruple blocks:
In this way, the letter A is considered for the intervention group and the letter B for the control group. Then we write all the permutation combinations of the letters A, A, B and B, which are 6 different combinations, on 6 cards as follows:
1. AABB ،
2. ABBA ،
3. ABAB ،
4. BAAB ،
5. BABA ،
6. BBAA
Then we randomly select a digit from 1 to 6 digits(with the help of a table of random numbers or we ask patient number one to choose a card at random). For example, if the number 2 was selected the meaning is that the first person in the intervention group will be the next two people in the control group and the fourth person in the intervention group. And we continue this operation until the sample size reaches the quorum.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were aware of the general introduction of the study groups and will be kept blind only because they themselves are not aware of being in the intervention or control group.There seems to be no difference between the work done for the intervention and control groups (Auriculotherapy will be performed on both groups) and only the reader knows the difference between the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery and School of Rehabilitation, Tehran University of Medical Sciences
Street address
Simaye Iran
City
Tehran
Province
Tehran
Postal code
1816775733
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.TUMS.FNM.REC.1399.149
Health conditions studied
1
Description of health condition studied
Sleep disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep disorder
Timepoint
Third Trimester of pregnancy
Method of measurement
Pittsburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Auriculotherapy intervention will be performed for the members of the group which is placed on the three parts of the right ear (master shoulder, lung1and sleeping point) and will be for 4 weeks .Seeds will be replaced once a week. Samples should be pressed on the ear three times a day for one minute each time.Two and four weeks after the start of the intervention, the questionnaire will be completed by the samples.
Category
Treatment - Devices
2
Description
Control group: Auriculotherapy will also be performed for the control group with the difference that in this group only glue (without seed)it will be placed on the right ear in three parts (sensory, throat and neck) for 4 weeks and if the adhesives are removed from the ear, they will be replaced. Two and four weeks after the start of the intervention, the questionnaire will be completed by the samples.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Dr. Elham Ebrahimi
Street address
Railway Square
City
Tehran
Province
Tehran
Postal code
12299
Phone
+98 21 5565 8500
Email
baharloo@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Gholam Hossein Rahimi Sherbaf
Street address
Quds Street
City
Tehran
Province
Tehran
Postal code
۶۴۸۹۱-۱۴۶۶۶
Phone
+98 21 8223 1000
Email
info@msrt.ir
Grant name
Vice Chancellor for Research, Tehran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nusrat Sharqi
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
ebrahimi_308@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nusrat Sharqi
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
61054000
Email
ebrahimi_308@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nusrat Sharqi
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
61054000
Email
ebrahimi_308@yahoo.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
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