History
# Registration date Revision Id
2 2020-11-21, 1399/09/01 159665
1 2020-04-04, 1399/01/16 127942
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  • Protocol summary

    This study is a clinical trial with a control group, with parallel groups, single-blind, Randomized by a coin toss, the sample size is 90, 2–3 phase.
    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.
    این پژوهش از نوع کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تک سو کور ، تصادفی شده به روش پرتاب سکه،حجم نمونه 90، فاز 2-3می باشد
    این پژوهش از نوع کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، تک سو کور ، تصادفی شده به روش پرتاب سکه،حجم نمونه 106، فاز 2-3می باشد
    Depression, anxiety, stress and fatigue are common problems in people with MS. Interventions are needed to improve these complications.90 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 receive no intervention. 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.
    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.
    افسردگی، اضطراب ،استرس و خستگی از مشکلات شایع مبتلایان به ام اس است. انجام مداخلات جهت بهبود عوارض مذکور ضروری است.90 شرکت کننده از انجمن مبتلایان به ام‌اس شهر مشهد، دارای معیارهای ورودبه طور تصادفی به دو گروه تخصیص داده خواهند شد.در گروه مداخله طب فشاری در نقاط یین تانگ و شن من به مدت یکماه اعمال خواهدشد.گروه کنترل،مداخله ای دریافت نخواهد کرد.قبل و یک روز پس از پایان مداخله پرسشنامه های DASS42 و FSSتکمیل خواهند شد.آنالیز کننده اطلاعات از گروه ها و نوع مداخله در هر گروه مطلع نخواهد بود.کور سازی با روش کدگزاری پرسشنامه ها انجام خواهد شد.
    افسردگی، اضطراب ،استرس و خستگی از مشکلات شایع مبتلایان به ام اس است. انجام مداخلات جهت بهبود عوارض مذکور ضروری است.106شرکت کننده از انجمن مبتلایان به ام‌اس شهر مشهد، دارای معیارهای ورودبه طور تصادفی به دو گروه تخصیص داده خواهند شد.در گروه مداخله طب فشاری در نقاط یین تانگ و شن من به مدت یکماه اعمال خواهدشد.گروه کنترل،2.5 سانتی متر بالاتر از شن من و 3 سانتی متر بالاتر از یین تانگ را فشار خواهند داد.قبل و یک روز پس از پایان مداخله پرسشنامه های DASS42 و FSSتکمیل خواهند شد.آنالیز کننده اطلاعات از گروه ها و نوع مداخله در هر گروه مطلع نخواهد بود.کور سازی با روش کدگزاری پرسشنامه ها انجام خواهد شد.
    Intervention group:45 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: The control group will not receive any intervention.
    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.
    گروه مداخله:45 بیماردر گروه مداخله قرار خواهند گرفت .مشارکت کنندگان به مدت 15 دقیقه نواحی طب فشاری HT7 و GV29 را فشار خواهند داد. مداخله هرروز صبح به مدت 15 دقیقه(هر دست 5 دقیقه و چشم سوم نیز 5 دقیقه) به مدت یک ماه خواهد بود. یک روز پس از پایان مداخله پرسشنامه 42 DASS و پرسشنامه FSS توسط بیماران تکمیل خواهد شد. گروه کنترل:گروه کنترل مداخله ای دریافت نخواهد کرد.
    گروه مداخله:53 بیمار در گروه مداخله قرار خواهند گرفت .مشارکت کنندگان به مدت 15 دقیقه نواحی طب فشاری HT7 و GV29 را فشار خواهند داد. مداخله هرروز صبح به مدت 15 دقیقه(هر دست 5 دقیقه و چشم سوم نیز 5 دقیقه) به مدت یک ماه خواهد بود. یک روز پس از پایان مداخله پرسشنامه 42 DASS و پرسشنامه FSS توسط بیماران تکمیل خواهد شد. گروه کنترل: 2.5 سانتی متر بالاتر از شن من و 3 سانتی متر بالاتر از یین تانگ را فشار خواهند داد.
  • General information

    90
    106
    empty
    Sample size correction and convert control group to sham group
    empty
    تصحیح حجم نمونه و تبدیل گروه کنترل به گروه شم
    90 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).
    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).
    90 بیمار دارای معیار های ورود با استفاده از پرتاب سکه به طور تصادفی به دو گروه مداخله و کنترل تخصیص داده خواهند شد.کلیه بیماران واجد شرایط ورود به مطالعه طی فاصله زمانی تعیین شده (آبان 1398 تا اردیبهشت 1399) انتخاب میشوند (مدل تصادفی ساده پوآسون)، به این صورت که پنج نفر اول با پرتاب سکه (شیر) در گروه مداخله و (خط) در گروه کنترل قرار میگیرند، متعاقبا پنج نفر بعدی در گروه دیگر قرار خواهند گرفت.
    106 بیمار دارای معیار های ورود با استفاده از پرتاب سکه به طور تصادفی به دو گروه مداخله و کنترل تخصیص داده خواهند شد.کلیه بیماران واجد شرایط ورود به مطالعه طی فاصله زمانی تعیین شده (آبان 1398 تا اردیبهشت 1399) انتخاب میشوند (مدل تصادفی ساده پوآسون)، به این صورت که پنج نفر اول با پرتاب سکه (شیر) در گروه مداخله و (خط) در گروه کنترل قرار میگیرند، متعاقبا پنج نفر بعدی در گروه دیگر قرار خواهند گرفت.
  • Intervention groups

    #1
    Intervention group: The participants in this study will be MS patients in Mashhad. Intervention group:45 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.
    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.
    گروه مداخله: شرکت کنندگان در پژوهش حاضر،بیماران مبتلا به ام اس شهر مشهد خواهند بود. 45 بیماردر گروه مداخله قرار خواهند گرفت .مشارکت کنندگان نواحی طب فشاری HT7 و GV29 را فشار خواهند داد. مداخله هر روز صبح به مدت 15 دقیقه(هر دست 5 دقیقه و چشم سوم نیز 5 دقیقه) به مدت یک ماه خواهد بود. یک روز پس از پایان مداخله پرسشنامه 42 DASS و پرسشنامه FSS توسط بیماران تکمیل خواهد شد.
    گروه مداخله: شرکت کنندگان در پژوهش حاضر،بیماران مبتلا به ام اس شهر مشهد خواهند بود. 53 بیماردر گروه مداخله قرار خواهند گرفت .مشارکت کنندگان نواحی طب فشاری HT7 و GV29 را فشار خواهند داد. مداخله هر روز صبح به مدت 15 دقیقه(هر دست 5 دقیقه و چشم سوم نیز 5 دقیقه) به مدت یک ماه خواهد بود. یک روز پس از پایان مداخله پرسشنامه 42 DASS و پرسشنامه FSS توسط بیماران تکمیل خواهد شد.
    #2
    Control group: The control group will not receive any intervention
    Control group: i participantswill press 2.5 cm above shenmen and 3 cm above Yin Tang acupoints .
    گروه کنترل: گروه کنترل مداخله ای دریافت نخواهد کرد.
    گروه شم: اعمال طب فشاری بر 2.5 سانتی متر بالاتر از نقطه شن من و 3 سانتی متر بالاتر از نقطه یین تانگ.
  • Recruitment centers

    #1
    Name of recruitment center - English: Ghaem hospital
    Name of recruitment center - Persian: بیمارستان قائم
    Full name of responsible person - English: Fatemeh Tara
    Full name of responsible person - Persian: فاطمه تارا
    Street address - English: the beginning of parastar street, Ahmadabad street
    Street address - Persian: خیابان احمد آباد.ابتدای خیابان پرستار
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 99199-91766
    Phone: +98 51 3840 0001
    Fax:
    Email: taraf@mums.ac.ir
    Web page address:
    Name of recruitment center - English: Ghaem hospital
    Name of recruitment center - Persian: بیمارستان قائم
    Full name of responsible person - English: Fatemeh Tara
    Full name of responsible person - Persian: فاطمه تارا
    Street address - English: The beginning of parastar street, Ahmadabad street
    Street address - Persian: خیابان احمد آباد.ابتدای خیابان پرستار
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 99199-91766
    Phone: +98 51 3840 0001
    Fax:
    Email: Taraf@mums.ac.ir
    Web page address:

Protocol summary

Study aim
ِDetermine the effect of acupressure on stress, anxiety, depression, and fatigue in patients with MS
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion 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, sedative drugs and tobacco, acne, ulcer or skin lesions in acupressure points.
Intervention groups
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.
Main outcome variables
Stress, anxiety, depression, fatigue

General information

Reason for update
Sample size correction and convert control group to sham group
Acronym
IRCT registration information
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
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Hossein Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1427
Email address
hosseinrahimi92@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-04-29, 1399/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on depression, stress, anxiety and fatigue in patients with multiple sclerosis
Public title
The effect of acupressure on depression, stress, anxiety and fatigue in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
To 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
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).
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Central Building of Birjand University of Medical Sciences, Ghorfari Street, Birjand, South Khorasan
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.BUMS.REC.1398.218

Health conditions studied

1

Description of health condition studied
Stress
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified

2

Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

3

Description of health condition studied
depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features

4

Description of health condition studied
fatigue
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The level of stress in MS patients.
Timepoint
Before and one day after the end of intervention
Method of measurement
Stress score from the depression, anxiety and stress scale-42

2

Description
The level of anxiety in MS patients.
Timepoint
Before and one day after the end of intervention
Method of measurement
Anxiety score from the depression, anxiety, stress scale-42

3

Description
The level of depression in MS patients
Timepoint
Before and one day after the end of intervention
Method of measurement
Depression score from the depression, anxiety, stress scale-42

4

Description
The level of fatigue in MS patients.
Timepoint
Before and one day after the end of intervention
Method of measurement
Fatigue score from the Fatigue severity scale

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
Control group: i participantswill press 2.5 cm above shenmen and 3 cm above Yin Tang acupoints .
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Fatemeh Tara
Street address
The beginning of parastar street, Ahmadabad street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Email
Taraf@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba kazemi
Street address
Central Building of Birjand University of Medical Sciences,Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
drtooba.kazemi@ gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717852577
Phone
+98 56 3238 1427
Fax
Email
Hosseinrahimi92@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Fax
Email
Hosseinrahimi92@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghafari
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1427
Fax
Email
Hosseinrahimi92@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable participants
When the data will become available and for how long
Start of access period 12 months after printing results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
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.
From where data/document is obtainable
Applicants can apply to the Birjand University of Medical Sciences School of Nursing and Midwifery for information.
What processes are involved for a request to access data/document
After verifying the identity of the applicant, the data will be submitted to the researcher within 2 weeks.
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