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Effect of acupressure on severity of fatigue and quality of life of asthmatic pation

Protocol summary

Summary
This study is a randomized clinical trial of the effect of acupressure on fatigue and quality of life of patients with asthma review.The study population of patients with asthma are referred to Hospital clinics Yazd University of Medical Sciences.Of the two existing centers in their asthma care routine is almost identical to sample one of the randomly selected for the intervention group and another for the control group.36 samples were randomly placed in each group Between the two groups in terms of age, sex and severity of asthma as possible will be matched.Patients in the control group will receive routine care and patients in the experimental group, in addition to routine care center, Acupressure (20 minutes Chinese massage for each person on the ST36, SP6, GB34, LU1, KI1 3 days a week 8 weeks) also receive.Before starting the study, the consent of the participants are taken, then individual data using demographic questionnaire, a questionnaire on quality of life, quality of life (SF36) and fatigue them with a measure of fatigue (FSS ) to be collected in both groups.Telephone follow-up is done by the researchers, and then in two steps, the fourth and eighth weeks after the start of the study in both groups filled questionnaires and the results analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015080823554N1
Registration date: 2015-09-28, 1394/07/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-28, 1394/07/06
Registrant information
Name
Fatemeh Dehghanizadeh Baghdadabad
Name of organization / entity
School of Nursing and Midwifery, Tehran
Country
Iran (Islamic Republic of)
Phone
+98 35 3253 7296
Email address
nejatio@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2015-05-10, 1394/02/20
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of acupressure on severity of fatigue and quality of life of asthmatic pation
Public title
The effect of acupressure on fatigue and quality of life of asthmatic pation
Purpose
Supportive
Inclusion/Exclusion criteria
- Inclusion criteria: In this study, all subjects in addition to the informed consent must also meet the following conditions. 1) younger than 65 and older than 18 years. 2) have an incentive to participate in the study. 3) The disease is confirmed by the medical experts and the results of diagnostic tests. 4) lowering medications such as amantadine not use fatigue. 5) disease is not known psychological and psychiatric drugs affecting their consumption. 6) the ability to understand their conversation in Farsi. 7) are literate. 8) the possibility of establishing direct telephone contact with the patients' residence there. - Exclusion criteria: 1) consent to continue participating in each stage of intervention. 2) the absence of the patient in the two sessions of acupressure 3) During the study, the disease progresses or the patient dies.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Deputy Tehran University of Medical Sciences
Street address
sixth floor of the University Center, Qods St, Keshavarz Blvd. Tel: 88987382 - Fax: 88989664
City
tehran
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
9111196022-138192

Health conditions studied

1

Description of health condition studied
asthma
ICD-10 code
J45.0
ICD-10 code description
Predominantly allergic asthma

Primary outcomes

1

Description
Fatigue
Timepoint
Before the study, 4 and 8 weeks after the start of the study
Method of measurement
پرسشنامه fss

2

Description
quality of life
Timepoint
Before the study, 4 and 8 weeks after the start of the study
Method of measurement
Sf36 questionnaire

Secondary outcomes

1

Description
second-hand smoke
Timepoint
Before the intervention
Method of measurement
Questions demographic questionnaire

2

Description
Type tobacco And duration of use
Timepoint
Before the intervention
Method of measurement
Questions demographic questionnaire

3

Description
Time to quit smoking
Timepoint
Before the intervention
Method of measurement
Questions demographic questionnaire

4

Description
Number of cigarettes smoked per day
Timepoint
Before the intervention
Method of measurement
Questions demographic questionnaire

5

Description
Smoking habits
Timepoint
Before the intervention
Method of measurement
Questions demographic questionnaire

Intervention groups

1

Description
Patients in the control group routine care referral center include the period (2 months) under the doctor's clinic and receive medication adjustments.
Category
Other

2

Description
Patients in the experimental group received acupressure also receive routine care center. In the experimental group, Chinese acupressure on the ST36 (in the anterior part of the leg and within the width of a finger spines anterior tibia), SP6 (the medial tibia posterior side of the leg above the medial malleolus), GB34 (in the inferior frontal troughs the fibula bone), LU1 (in the chest outside the chest and in the intercostal space), KI1 (in the soles of the feet are 3/1 and 3/2 imaginary line between the second and third toes and heel) in sides for 2 minutes per point (1 minute direct pressure with the thumb until the person feels pain, distention, and more with the same amount of flow and pressure 1 minute massage is done in a clockwise direction) total 20-minute massage per person, 3 days per week for 8 weeks on patients there.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital Clinic
Full name of responsible person
Maryam Abooei
Street address
City
Mehriz

2

Recruitment center
Name of recruitment center
shahid Sadoughi Hospital Clinic
Full name of responsible person
Maryam Broomand
Street address
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Center School of Nursing and Midwifery, Tehran
Full name of responsible person
Dr.Ziba Taghizadeh
Street address
Faculty of Nursing & Midwifery, Tohid square, Nosrat Eastern St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center School of Nursing and Midwifery, Tehran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences,School of Nursing and Midwifery
Full name of responsible person
Shadan Pedramrazi
Position
Educator Faculty member/Master in Nursing Education
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
pedramrazi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences,School of Nursing and Midwifery
Full name of responsible person
Shadan Pedramrazi
Position
Educator Faculty member/Master in Nursing Education
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square, Nosrat Eastern St
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
pedramrazi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran
Full name of responsible person
Fatemeh Dehghanizadehbaghdadabad
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square, Nosrat Eastern St
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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