Determining the effect of diaphragmatic breathing on pain, sleep and fatigue in patients with metastatic gastrointestinal cancers
Design
Clinical trial with control group, with a simple random method, participants are randomly assigned to two groups of intervention and control using a card. There are 22 participants in each group.
Settings and conduct
The place of study is oncology wards and preferably in the hospital room.
Patients breathe diaphragmally sitting or lying down in bed, depending on their comfort.
Participants/Inclusion and exclusion criteria
Login: Satisfaction for cooperation. Diagnosis of metastatic gastrointestinal cancer. Age 18-50 years. Periodic experience of pain, sleep disturbance and unusual fatigue.
Exit: Death. Discharge. Drug abuse. Patients with Glasgow coma less than 7
Intervention groups
In the intervention group, diaphragmatic breathing will be performed twice a day for 10 minutes for 10 minutes.
There is no intervention in the control group.
Main outcome variables
The main outcome of the study is pain relief, improved sleep, and reduced fatigue.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053628N1
Registration date:2022-02-05, 1400/11/16
Registration timing:prospective
Last update:2022-02-05, 1400/11/16
Update count:0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
martam rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3427 6303
Email address
nasim_nina72@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial study The effect of diaphragmatic breathing on pain, sleep and fatigue in patients with metastatic gastrointestinal cancers
Public title
The effect of diaphragmatic breathing on pain, sleep and fatigue in patients with metastatic gastrointestinal cancers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction for cooperation
Diagnosis of metastatic gastrointestinal cancer based on the opinion of the treating physician
Age 18-50 years
No history of drug use
No history of debilitating musculoskeletal diseases
Periodic experience of chronic pain based on the tools of Van Korf et al
Periodic fatigue experience based on Piper tools
Periodic experience of sleep disorders based on the Petersburg instrument
Exclusion criteria:
Death during the intervention period
Discharge from the oncology department during the intervention period
Decreased consciousness so that they are unable to continue cooperating during the intervention period
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple random method using a card will be used. 2 types of cards A and B A total of 44 cards that
Where 22 cards A and 22 cards B and then the participant randomly picks up one of the cards and is placed in one of the control or test groups. The people who take the A card are in the test group and the rest are in the control group. Individuals in the experimental group are trained and breathing exercises are performed, but there is no training or intervention in the control group. The researcher registers the people and assigns them to the test and control groups in a simple random way with a card.
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 Kermanshah University of Medical Sciences
Street address
in front of Imam Ali Hospital, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714895664
Approval date
2022-01-11, 1400/10/21
Ethics committee reference number
IR.KUMS.REC.1400.759
Health conditions studied
1
Description of health condition studied
Metastatic cancers of the gastrointestinal tract
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organs
Primary outcomes
1
Description
The primary consequence is a pain management plan.
Timepoint
Before the intervention and after 10 days
Method of measurement
Visual Analogue Scale. Chronic Pain Questionnaire by Van Korf et al.
Secondary outcomes
1
Description
The secondary outcome variable is improved sleep seeking pain relief.
Timepoint
Before the intervention and then 10 days after the intervention .
Method of measurement
Petersburg Sleep Quality Questionnaire.
2
Description
The secondary outcome variable of fatigue recovery seeks pain relief.
Timepoint
Before the intervention and then 10 days after the intervention .
Method of measurement
Piper Fatigue Scale Questionnaire.
Intervention groups
1
Description
"Intervention group": Intervention group: In the intervention group, diaphragmatic breathing will be performed for 10 days and twice a day (9 am and 9 pm) for 10 minutes. Diaphragmatic breathing is basically done in both supine and sitting positions. Patients are instructed to lie down: Participants lie comfortably on the bed, focusing on the lower abdomen, bending the knees, and using pillows under the legs as needed. For a sitting position, the knees are bent and one hand is placed on the upper chest and the other hand on the lower chest. Place the immobile tongue in the floor of the mouth, relax by taking a deep breath and exhaling it slowly. . Hold your breath for 2-5 seconds and then exhale slowly through your mouth. It is best to calm the environment as much as possible to prevent distractions and avoid talking during the process.
Category
Other
2
Description
"Control group": There is no intervention in the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Ayatollah Taleghani Hospital
Full name of responsible person
Maryam Rezaei
Street address
Unit9,Culture building, Moallem Town
City
Kermanshah
Province
Kermanshah
Postal code
6714895664
Phone
+98 83 3427 6319
Email
nasim_nina72@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
in front of Imam Ali Hospital, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 0097
Email
kums@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
50
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
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 9, Farhang Building, Moallem Town
City
Kermanshah
Province
Kermanshah
Postal code
6714895664
Phone
+98 83 3427 6319
Email
nasim_nina72@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Reza Abdi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kermanshah University of Medical Sciences.
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3427 6477
Email
a_abdi61@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 9, Farhang Building, Moallem Town
City
Kermanshah
Province
Kermanshah
Postal code
6714895664
Phone
+98 83 3427 6319
Email
nasim_nina72@yahoo.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