Determining the effect of five minutes of mindful breathing on pain and fatigue in patients with gastrointestinal cancer
Design
70 patients will be divided into two groups of 35 people, intervention and control, in the form of block randomization with size 4, with the help of the randomization table.
Settings and conduct
This study is on patients who have referred to Arin Amel clinic.The trainings are in groups of five in person with videos and pamphlets. The intervention group is a member of an internet group and is followed up. Questionnaires are completed before the intervention, two weeks after the intervention, and four weeks after the intervention by both groups. Conscious breathing means deep and long abdominal breaths, during which the patient focuses only on his breathing. This breathing is one of the mind and body exercises and in the field of complementary medicine, it is a branch of energy therapy.
Participants/Inclusion and exclusion criteria
Gastrointestinal cancer patients of both genders between 18 and 65 years old, who have a pain score between 3-7 and suffer from fatigue. do not have other serious physical diseases and have the ability to cooperate. They should not use narcotics and nerve drugs. They should be undergoing chemotherapy and their disease has not metastasized.
Intervention groups
The intervention group performed five minutes of mindful breathing three times a day for one month And the control group receives only the normal nursing intervention.
Main outcome variables
Reduction of pain and fatigue scores in patients with gastrointestinal cancer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240115060700N1
Registration date:2024-03-06, 1402/12/16
Registration timing:prospective
Last update:2024-03-06, 1402/12/16
Update count:0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Narges Rajabzadeh tabari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4324 6098
Email address
rajabzadenarges@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Five-minute mindful breathing on pain and fatigue in gastrointestinal cancer patients
Public title
The effect of deep and long breathing on pain and fatigue of gastrointestinal cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with various gastrointestinal cancers during chemotherapy
The ability to cooperate in doing breathing exercises and answering questionnaires
Consent to participate in the study
Age 18 to 65 years
Having symptoms of pain and fatigue (according to the patient's own report)
Having a pain score between 3-7 based on the pain ruler
Exclusion criteria:
Having mental illness and other serious illnesses
Use of psychiatric drugs and narcotics
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with size 4 will divide into two groups of 35 people, intervention and control. Block method and randomization table will be used for random assignment to intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Shahid Rajaei Institute of Cardiovascular Research and Treatment, Tehran
Street address
Niayesh Square, next to Mellat Park, Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2023-12-02, 1402/09/11
Ethics committee reference number
IR.RHC.REC.1402.076
Health conditions studied
1
Description of health condition studied
Types of gastrointestinal cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in McGill pain questionnaire and fatigue score in Smets questionnaire
Timepoint
Questionnaires are filled at the beginning of the intervention (before the intervention) and 14 and 30 days after the intervention.
Intervention group: Intervention group: for one month, three times a day, morning, noon and night, they perform five minutes of mindful breathing. They sit or lie down in a comfortable place and take deep and long breaths (inhale for a few seconds, hold the breath for a few seconds, and exhale for a few seconds). As they breathe, they focus on their breathing and refocus on their breathing whenever their mind wanders. It is a face-to-face training with videos and brochures.
Category
Rehabilitation
2
Description
Control group: They do not receive training and receive the same usual nursing care, but questionnaires are filled by them before the intervention, two weeks after the intervention, and one month after that.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arin Amel specialized and super-specialized clinic
Full name of responsible person
Dr Ramin Yeganeh
Street address
Elghelab St, in front of the Municipality, Haft Tir Square
City
Amol
Province
Mazandaran
Postal code
4615778871
Phone
+98 11 4415 3550
Email
rajabzadenarges@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaei, Cardiovascular and Research Center, Tehran
Full name of responsible person
Dr Saeideh mazlomzadeh
Street address
Niayesh Square, next to Mellat Park, Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
rajabzadenarges@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaei, Cardiovascular and Research Center, Tehran
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
Shahid Rajaei Cardiovascular Medical and Research Center, Tehran
Full name of responsible person
Narges Rajabzade Tabari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh Crossroads, next to Mellat Park,Waliasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3063
Fax
+98 21 2204 2026
Email
rajabzadenarges@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahaed Rajaei Cardiovascular Medical and Reseqarch Center, Tehran
Full name of responsible person
Narges Rajabzade Tabari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh Crossroads, next to Mellat Park,Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3063
Fax
+98 21 2204 2026
Email
rajabzadenarges@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shaheaid Rajaei Cardiovascular Medical and Research Center, Tehran
Full name of responsible person
Narges Rajabzade Tabari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niayesh Crossroads, next to Mellat Park, Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
009821923063
Fax
+98 21 2204 2026
Email
rajabzadenarges@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available