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General information
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Due to the availability of a large number of research samples in this age range and the limitations of the study on the effect of laughter yoga on the mentioned problems in this age group, researchers are interested in continuing the study in this age range and adding this age group to the study.
Due to the availability of a large number of research samples in this age range and the limitations of the study on the effect of laughter yoga on the mentioned problems in this age group, researchers are interested in continuing the study in this age range and adding this age group to the study.
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با توجه به دردسترس بودن تعداد زیاد نمونه پژوهش در این رنج سنی و محدودیت مطالعه در زمینه تاثیر یوگا بر مشکلات مذکور در این گروه سنی پژوهشگران علاقمند به ادامه مطالعه در این رنج سنی و اضافه کردن این گروه سنی به مطالعه می باشند.
با توجه به دردسترس بودن تعداد زیاد نمونه پژوهش در این رنج سنی و محدودیت مطالعه در زمینه تاثیر یوگا بر مشکلات مذکور در این گروه سنی پژوهشگران علاقمند به ادامه مطالعه در این رنج سنی و اضافه کردن این گروه سنی به مطالعه می باشند.
Secondary outcomes
#1
empty
sleep quality
sleep quality
empty
کیفیت خواب
کیفیت خواب
empty
sleep quality is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy
sleep quality is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy
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کیفیت خواب یک بار قبل از شروع اولین جلسه شیمی درمانی و یک بار پس از چهارمین جلسه شیمی درمانی سنجیده خواهد شد
کیفیت خواب یک بار قبل از شروع اولین جلسه شیمی درمانی و یک بار پس از چهارمین جلسه شیمی درمانی سنجیده خواهد شد
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Petersburg Sleep Quality Tool
Petersburg Sleep Quality Tool
empty
ابزار کیفیت خواب پیترزبورگ
ابزار کیفیت خواب پیترزبورگ
#2
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Depression
Depression
empty
افسردگی
افسردگی
empty
Depression is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy
Depression is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy
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افسردگی یک بار قبل از شروع اولین جلسه شیمی درمانی و یک بار پس از چهارمین جلسه شیمی درمانی سنجیده خواهد شد
افسردگی یک بار قبل از شروع اولین جلسه شیمی درمانی و یک بار پس از چهارمین جلسه شیمی درمانی سنجیده خواهد شد
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Beck Depression Tools
Beck Depression Tools
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ابزار افسردگی بک
ابزار افسردگی بک
#3
empty
Quality of Life
Quality of Life
empty
کیفیت زندگی
کیفیت زندگی
empty
Quality of Life is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherap
Quality of Life is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherap
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کیفیت زندگی یک بار قبل از شروع اولین جلسه شیمی درمانی و یک بار پس از چهارمین جلسه شیمی درمانی سنجیده خواهد شد
کیفیت زندگی یک بار قبل از شروع اولین جلسه شیمی درمانی و یک بار پس از چهارمین جلسه شیمی درمانی سنجیده خواهد شد
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European Organization for Research and Treatment of Cancer tools
European Organization for Research and Treatment of Cancer tools
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ابزار کیفیت زندگی سازمان اروپایی تحقیق و درمان سرطان
ابزار کیفیت زندگی سازمان اروپایی تحقیق و درمان سرطان
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen tafaghody
Full name of responsible person - Persian: محسن تفقدی
Street address - English: University Blvd
Street address - Persian: خیابان دانشگاه
City - English: mashhhsd
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 2081
Fax:
Email: vpresearch@mums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohsen Tafaghody
Full name of responsible person - Persian: محسن تفقدی
Street address - English: University Blvd
Street address - Persian: خیابان دانشگاه
City - English: Mashhhsd
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9138813944
Phone: +98 51 3841 2081
Fax:
Email: vpresearch@mums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohsen tafaghodyTafaghody Full name of responsible person - Persian: محسن تفقدی Street address - English: University Blvd Street address - Persian: خیابان دانشگاه City - English: mashhhsdMashhhsd City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9138813944 Phone: +98 51 3841 2081 Fax: Email: vpresearch@mums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effect of laughing yoga on nausea, vomiting and mental well-being in chemotherapy patients
Design
This research has two groups of control and intervention. Randomization is done by spss software. The sample size is 30 patients for the intervention group and 30 patients for the control group. In this study, the study design is parallel. Type of trial is equivalence. Blindness in this study is blind.
Settings and conduct
This study was conducted on patients undergoing chemotherapy in Reza Medical Center located at Client's Blvd. Laugh yoga program is conducted in the hall near the chemotherapy department.
Participants/Inclusion and exclusion criteria
1. Refer to Imam Reza Medical Center for chemotherapy.
2- Age between 18 and 60 years.
3. Be alert.
4. Have non-metastatic cancer.
5. Satisfaction to participate in the research.
6. Do not have audible and visual problems.
7. Phone number to track.
8. A moderate or severe chemotherapy regimen.
9. Between two to four sessions of chemotherapy in one week.
10. No symptoms of osteomyte.
11. Do not have upper gastrointestinal cancer.
12. Do not use radiotherapy.
13. Physically and mentally healthy.
Intervention groups
In the intervention group: people will laugh yoga for 20-30 minutes before the first to the fourth session of chemotherapy. Laugh yogic exercises include the four main clapping steps, deep breathing, baby play and laugh exercises. After each lag yoga session, chemotherapy is performed according to the protocol in the center. Yoga exercises are grouped together. And the number of groups is from 2 to 15 people.
In the control group, other than the usual self-care education to control the nausea by the researcher (about 5 minutes), no further action will be taken.
Main outcome variables
nausea, severity of nausea, duration of nausea, vomiting, vomiting duration, vomiting and well-being score
General information
Reason for update
Due to the availability of a large number of research samples in this age range and the limitations of the study on the effect of laughter yoga on the mentioned problems in this age group, researchers are interested in continuing the study in this age range and adding this age group to the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039463N1
Registration date:2018-08-21, 1397/05/30
Registration timing:prospective
Last update:2020-07-16, 1399/04/26
Update count:2
Registration date
2018-08-21, 1397/05/30
Registrant information
Name
mohammad namazinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 5280
Email address
namazinm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of laugher yoga on emesis and mental wellbeing in patients under chemotherapy with non-metastatic cancer
Public title
The effect of laugher yoga on emesis and mental wellbeing in patients under chemotherapy with non-metastatic cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
To chemotherapy, they have visited Imam Reza's center of Mashhad.
Age between 18 and 60 years old.
Be alert.
Have non-metastatic cancer (based on diagnostic tests, signs and clinical examinations and an approved oncology doctor).
Complete consent to participate in the research.
Auditory problems (full hearing despite the use of auxiliary equipment) and visual (the ability to read a newspaper at a distance of 30 centimeters with glasses).
The phone number should be available to the researcher for follow up.
A chemotherapy regimen with moderate or severe nausea.
The number of chemotherapy sessions between two to four sessions per week is prescribed to him.
There are no symptoms of osteomyitis (such as redness, burning and mouth ulcers, the presence of false membranes, and sputum in the mouth).
Do not have upper gastrointestinal cancer.
Do not use radiotherapy at the same time.
Mentally and physically, you can do yoga exercises.
Exclusion criteria:
Do not want to continue to participate in research.
At the time of the research, there was a major stress (close relatives' death, financial failure, etc.).
Worried and needs special care.
The chemotherapy program is postponed by thrombocytopenia or any other factor.
Diagnosis of metastasis is based on diagnostic tests by an oncology specialist.
Symptoms of osteomyitis (such as redness, burning and mouth ulcers, false membranes, and sputum in the mouth).
For whatever reason, you will not be able to attend laugh yoga sessions.
Changes to the chemotherapy regimen.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random Type: Simple
In this method, computer randomization methods are used, and the division of people into two groups is done randomly by the sequence generated by SPSS software. The unit is the individual accident. Allocation Concealment Hiding is done by the statistic consultant.
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
Ethics committee of school of nursing & midwifery-mashhad university of medical sciences
Street address
Mashhad, Ibn Sina St.-doctora four war
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.021
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C80
ICD-10 code description
Malignant neoplasm without specification of site
Primary outcomes
1
Description
Frequency of nausea
Timepoint
Nausea before the onset of the intervention and at each chemotherapy session for up to four sessions
Method of measurement
MORROW ASSESSMENT OF NAUSEA AND EMESIS
2
Description
Severe of nausea
Timepoint
Severe of Nausea before the onset of the intervention and at each chemotherapy session for up to four sessions
Method of measurement
MORROW ASSESSMENT OF NAUSEA AND EMESIS
3
Description
Duration of nausea
Timepoint
Duration Nausea before the onset of the intervention and at each chemotherapy session for up to four sessions
Method of measurement
MORROW ASSESSMENT OF NAUSEA AND EMESIS
4
Description
Frequency of vomiting
Timepoint
vomiting before the onset of the intervention and at each chemotherapy session for up to four sessions
Method of measurement
MORROW ASSESSMENT OF NAUSEA AND EMESIS
5
Description
Duration of vomiting
Timepoint
Duration of vomiting before the onset of the intervention and at each chemotherapy session for up to four sessions
Method of measurement
MORROW ASSESSMENT OF NAUSEA AND EMESIS
6
Description
Severe of nausea
Timepoint
severe of vomiting before the onset of the intervention and at each chemotherapy session for up to four sessions
Method of measurement
MORROW ASSESSMENT OF NAUSEA AND EMESIS
7
Description
well-being score
Timepoint
En well-being is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy.
Method of measurement
En To measure the score of well-being, we will use the Warwick-Edinburgh Subjective Well-Being Scale
Secondary outcomes
1
Description
sleep quality
Timepoint
sleep quality is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy
Method of measurement
Petersburg Sleep Quality Tool
2
Description
Depression
Timepoint
Depression is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherapy
Method of measurement
Beck Depression Tools
3
Description
Quality of Life
Timepoint
Quality of Life is measured once before the start of the first chemotherapy session and once after the fourth session of chemotherap
Method of measurement
European Organization for Research and Treatment of Cancer tools
Intervention groups
1
Description
"In the intervention group": people will laugh yoga for 20-30 minutes before the first to fourth chemotherapy sessions. Laugh yogic exercises include four main clapping steps, deep breathing, child play and laughter exercises. This program will be performed by the researcher (after receiving the necessary training) and under the supervision of a yoga laughter coach at the hall next to the chemo therapy section. The yoga program is laughing at talking about some cheerful issues such as national and religious ceremonies, having a positive sense of everyday life, and so on. Then touching with tracks 1, 2, and 3 begins to touch open hands so that the fingers and palms of each other are in contact. We continue to move up and down and form a pendulum with movement in other parts of the body. Then the voice is simple and simple as Ho Ho. In addition, coordinated movements have been added for fertility enhancer. Broken words and words, such as words used by children in the game, are said to help in reducing individual impediments and talent. Later, the exercises begin to start laughing, which helps the person to experience mental and physical relaxation. Laughter is looking for laughter. Later, yoga exercises begin, so that each exercise lasts about 30 to 45 seconds with the touch of ho ho horns and deep deep deeps, including laughing yoga practice techniques (laughter, laughter with closed mouths, gradual laughter) Laughter laugh, laughter, laughter, laughter, telephone conversation, laughter) and laughter techniques (laughter and laughter laugh, laughter, laughter, laughter, laughter ...). This program takes about 5 minutes. At the end of the contest, the words are said loudly: "I am the happiest man on earth". They repeat themselves and look at each other and laugh. It takes about 5 minutes. After each yoga session, chemotherapy is performed according to the protocol in the center
Category
Rehabilitation
2
Description
Control group: Except for the usual self-care education to control the nausea by the researcher (about 5 minutes), no further action will be taken.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Namazi Nia
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5222 5280
Email
namazinm951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Namazi Nia
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948988
Phone
+98 51 5222 5280
Email
namazinm951@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Namazi Nia
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nurse
Street address
Modares Street
City
Torbat-e Heydariyeh
Province
Razavi Khorasan
Postal code
9519883561
Phone
+98 51 5222 5280
Email
namazinm951@mums.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Presenting findings from research in seminars, conferences and publication of articles extracted from research in domestic and abroad journals for the use of non-metastatic cancer patients as well as researchers who intend to conduct research related to the subject matter.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Delivering research results to other researchers for further research.
Under which criteria data/document could be used
The results obtained in this study can be found in the oncology (cancer) sections of all hospitals and even in other sections, especially in chronic patients who require special medications due to their long-term complications and special care. Have to be used.
From where data/document is obtainable
Referring to Mashhad Nursing and Midwifery Faculty
What processes are involved for a request to access data/document
After sending the email to the person responsible for the response process begins.