Protocol summary
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Study aim
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Evaluation of the effect of Uriculotherapy on sleep quality of children with attention deficit hyperactivity disorder (ADHD) in Kashan in 2021
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Design
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A randomized double-blind clinical trial with a group design of 52 patients with control group (parallel groups).
Block randomization using Sealed Envelope Ltd. software. 2017 was performed.
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Settings and conduct
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Randomized clinical trial with control group, two-way blind (participants and outcome assessors) on eligible clients in Karegarnejad hospital in Kashan city
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Participants/Inclusion and exclusion criteria
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Inclusion criteria are; Age 6 to 11 years, Having Attention Deficit- Hyperactivity Disorder (ADHD), Get a score of 41 or higher on the CSHQ, Organ health in the earlobe area, Medicated for ADHD, Resident of Kashan, Iranian citizenship, Living with both parent, willing of mother and child to participate in the study, And non-entry criteria are; Acute serious illness, hospitalization, lack of access, Concomitant use of other non-pharmacological methods, Exposure to severe crises from 3 months prior to study, change in medication schedule for at least two weeks before the start of the study, simultaneous known psychiatric disorders and mental retardation Known chronic diseases, using sleeping pills, Suffering from blindness and deafness
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Intervention groups
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In the intervention group, Uriculotherapy will be performed using Vakaria sidewalls. In the comparison group, only the seedless label will be pasted on the points and no pressure will be applied on the points.
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Main outcome variables
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Sleep quality score
General information
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Reason for update
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Relocation of sampling due to ease of access to samples
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100211003329N7
Registration date:
2021-08-12, 1400/05/21
Registration timing:
prospective
Last update:
2022-01-03, 1400/10/13
Update count:
1
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Registration date
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2021-08-12, 1400/05/21
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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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Expected recruitment start date
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2021-09-23, 1400/07/01
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Expected recruitment end date
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2021-12-22, 1400/10/01
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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 Uriculotherapy on sleep quality in children with Attention Deficit- Hyperactivity Disorder (ADHD)
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Public title
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The effect of Uriculotherapy on sleep quality in children with Attention Deficit- Hyperactivity Disorder (ADHD)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 6 to 11 years
Suffering from Attention Deficit- Hyperactivity Disorder (ADHD) based on the diagnosis of pediatric psychiatrist according to DSM-5 criteria
Get a score of 41 or higher ( based on the CSHQ tools)
Organ health in the earlobe area
Medicated for ADHD
Resident in Kashan
Iranian citizenship
Living with both parent
Willing of mother and child to participate in the study
Exclusion criteria:
Exposure to acute and severe stress
Acute serious illness, hospitalization, lack of access
Concomitant use of other non-pharmacological methods
Exposure to severe crises from 3 months prior to study
Change in medication schedule for at least two weeks before the start of the study
Simultaneous known psychiatric disorders and mental retardation
Known chronic diseases (heart, respiratory, glandular and allergies diseases)
Using sleeping pills
Suffering from blindness and deafness
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Age
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From 6 years old to 11 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
52
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible samples will be assigned to each of the two intervention and comparison groups in the form of block randomization. 52 samples were entered into Sealed Envelope Ltd. software. 2017 through www.sealedenvelope.com. The size of the blocks was chosen unequally so that the person entering the samples into the groups could not guess the next sample group, actually it was defined for the software to divide people into two groups in the form of blocks with sizes 4, 6 and 8. The software defined 1 block of 4, 3 blocks of 8 and 4 blocks of 6.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The lead researcher places therapeutic or placebo sides on the participants' ears, and the research's colleague, who is unaware of the nature of the sides, performs further evaluations. Participants also have already been told that their sides may be therapeutic or placebo.
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Placebo
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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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2021-06-26, 1400/04/05
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Ethics committee reference number
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IR.KAUMS.REC.1400.015
Health conditions studied
1
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Description of health condition studied
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Attention deficit- hyperactivity disorder
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ICD-10 code
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F90.0
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ICD-10 code description
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Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
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Description
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Sleep quality score
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Timepoint
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Before the intervention, 4 weeks after the beginning of the intervention, 4 weeks after the end of the intervention
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Method of measurement
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Children's Sleep Habits Questionnaire
Secondary outcomes
1
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Description
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Allergy to sidewalls
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Timepoint
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Weekely
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Method of measurement
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Report of mother
Intervention groups
1
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Description
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Intervention group: In this group, Korean-made DONG BANG brand Vakaria sidewalls are glued by the researcher on Shenman, sympathetic, sub cortex, heart and endocrine points that are related to sleep quality. The mother and child will be instructed to press these sidewalls each time for three minutes with the index finger and thumb by the child (under the supervision of an adult) or a relative. During the 4 weeks of the intervention, the labels will be affixed by the researcher alternately on both ears every other week. The labels are placed on the ear for five days each week and the mother is instructed to remove them by the end of the fifth day to prevent possible allergic reactions. It is also noted that if the labels are removed during the five-day period, the researcher will be notified by telephone; In that case, the researcher will re-affix the labels with the consent of the family at their home, in the Karegarnejad hospital or wherever it is convenient for the family. The method of pressing the sidewalls will be taught to the intervention group by the researcher; In addition, during the intervention, a weekly diary will be provided to mothers, in which mothers will record possible allergic reactions, hypnotic use, frequency and duration of each pressure. Every week, all participants will be visited at the agreed location and new stickers will be affixed to them; A daily note sheet will be delivered to them and another sheet will be delivered to them next week. The information in the diaries is analyzed every week, and if the average number of times of pressure and the duration of each time of pressure on the sides is at least 2 times a day and 2 minutes each time, the sample will remain in the study. Labeling will continue for 4 weeks and samples will be followed up for 4 weeks after the intervention. In addition to starting the study, the CSHQ questionnaire will be completed after the intervention (end of the fourth week) and 4 weeks after the intervention (end of the eighth week) through face-to-face interviews with the mother by the research Fellow (who does not know how to divide the samples into two groups).
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Category
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Treatment - Drugs
2
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Description
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Control group: Auriculotherapy will be performed for 4 weeks, five days a week, three times a day and one hour before bedtime. In this group, Vakaria brand DONG BANG brand made in Korea on shenman, sympathetic, subcortex, heart and endocrine points that are related to sleep quality. Only the seedless label will be affixed to the points and no pressure will be applied to the points. It should be noted that during the 4 weeks of intervention, the labels will be affixed by the researcher alternately on both ears every other week. The labels are placed on the ear for five days each week and the mother is instructed to remove them at the end of the fifth day to prevent possible allergic reactions; It is also noted that if the labels are removed during the five-day period, the researcher will be notified by telephone; In that case, the researcher will re-affix the labels with the consent of the family at their home, in the Karegarnejad hospital or wherever it is convenient for the family.
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Category
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Placebo
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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Kashan University of Medical Sciences
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Not done yet
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available