Protocol summary
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Study aim
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ِDetermine the effect of acupressure on stress, anxiety, depression, and fatigue in patients with MS
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Design
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This study is a clinical trial with a control group, with parallel groups, single-blind, Randomized by a coin toss, the sample size is106, 2–3 phase.
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Settings and conduct
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Depression, anxiety, stress and fatigue are common problems in people with MS. Interventions are needed to improve these complications.106 participants from MS Association of Mashhad will be randomly assigned to two groups according to inclusion criteria. In the intervention group, the acupressure will be applied at Yintang and Shenmen points for one month.The control group will press 2.5 cm above shenmen and 3 cm above Yin Tang acupoints .
DASS42 and FSS questionnaires will be completed before and one day after the intervention.The data analyzer will not be aware of the groups and the type of intervention in each group. Blinding will be done by coding the questionnaires.
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Participants/Inclusion and exclusion criteria
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Relapsing Remitting MS, At least 6 months have passed since the diagnosis of MS, Maximum age 45 years, EDSS scores 1 to 4.5.
Exclusion criteria: history of psychosis, addiction to narcotics, stimulants, sedative drugs and tobacco, acne, ulcer or skin lesions in acupressure points.
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Intervention groups
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Intervention group:53 patients will be included in the intervention group. Participants will press the HT7 and GV29 acupressure points for 15 minutes. The intervention will be for 15 minutes each morning (5 minutes for each hand and 5 minutes for the third eye) for one month. One day after the intervention, patients will complete the DASS42 and FSS questionnaires.
Control group: 2.5 cm above shenmen and 3 cm above Yin Tang acupoints will press.
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Main outcome variables
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Stress, anxiety, depression, fatigue
General information
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Reason for update
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Sample size correction and convert control group to sham group
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190515043601N5
Registration date:
2020-04-04, 1399/01/16
Registration timing:
registered_while_recruiting
Last update:
2020-11-21, 1399/09/01
Update count:
1
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Registration date
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2020-04-04, 1399/01/16
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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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2019-11-01, 1398/08/10
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Expected recruitment end date
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2020-04-29, 1399/02/10
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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 acupressure on depression, stress, anxiety and fatigue in patients with multiple sclerosis
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Public title
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The effect of acupressure on depression, stress, anxiety and fatigue in patients with multiple sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Relapsing Remitting MS
At least 6 months have passed since the diagnosis of MS
Maximum age 45 years
EDSS scores 1 to 4.5
Exclusion criteria:
History of psychosis
Addiction to narcotics, stimulants ,sedatives drugs and tobacco
Acne, ulcer or skin lesions in acupressure points
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Age
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To 45 years old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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Sample size
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Target sample size:
106
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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106 patients who met inclusion criteria will be randomly assigned to intervention and control groups using the coin toss. All the eligible patients will be included in the study from November 2019 to April 2020 (The Poisson simple random sampling). The first five patients will be allocated to the intervention (head) or control (tail) group, and the second five patients will be allocated to the other group (tails) using tossing a coin. c).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The data analyst will be unaware of the type of intervention for each group.Pre-intervention questionnaires will be coded in the intervention group with the letter M and the control group with N. Questionnaires will be coded after intervention in intervention group with letter G and control group with H.The coding will be done by the researcher.No one other than the researcher will know about coding.
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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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2019-10-14, 1398/07/22
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Ethics committee reference number
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IR.BUMS.REC.1398.218
Health conditions studied
1
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Description of health condition studied
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Stress
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ICD-10 code
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F43.9
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ICD-10 code description
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Reaction to severe stress, unspecified
2
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Description of health condition studied
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anxiety
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ICD-10 code
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F06.4
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ICD-10 code description
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Anxiety disorder due to known physiological condition
3
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Description of health condition studied
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depression
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ICD-10 code
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F06.31
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ICD-10 code description
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Mood disorder due to known physiological condition with depressive features
4
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Description of health condition studied
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fatigue
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The level of stress in MS patients.
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Timepoint
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Before and one day after the end of intervention
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Method of measurement
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Stress score from the depression, anxiety and stress scale-42
2
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Description
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The level of anxiety in MS patients.
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Timepoint
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Before and one day after the end of intervention
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Method of measurement
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Anxiety score from the depression, anxiety, stress scale-42
3
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Description
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The level of depression in MS patients
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Timepoint
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Before and one day after the end of intervention
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Method of measurement
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Depression score from the depression, anxiety, stress scale-42
4
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Description
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The level of fatigue in MS patients.
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Timepoint
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Before and one day after the end of intervention
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Method of measurement
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Fatigue score from the Fatigue severity scale
Intervention groups
1
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Description
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Intervention group: The participants in this study will be MS patients in Mashhad. Intervention group:53 patients will be included in the intervention group. Participants will press the HT7 and GV29 acupressure points.The intervention will be for 15 minutes each morning (5 minutes for each hand and 5 minutes for the third eye) for one month. One day after the intervention, patients will complete the DASS42 and FSS questionnaires.
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Category
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Treatment - Other
2
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Description
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Control group: i participantswill press 2.5 cm above shenmen and 3 cm above Yin Tang acupoints .
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Category
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N/A
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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Birjand 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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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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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
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Title and more details about the data/document
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All potential data can be shared after unidentifiable participants
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When the data will become available and for how long
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Start of access period 12 months after printing results
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To whom data/document is available
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It will only be available to researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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In order to access the data, researchers can request access to the information 12 months after the results are published. Within two weeks, the information will be sent to them.It should be noted that applicants must be faculty members of the Ministry of Health.
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From where data/document is obtainable
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Applicants can apply to the Birjand University of Medical Sciences School of Nursing and Midwifery for information.
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What processes are involved for a request to access data/document
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After verifying the identity of the applicant, the data will be submitted to the researcher within 2 weeks.
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Comments
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