"Investigating the Effects of Diaphragmatic Breathing Training on Anxiety and Sleep Quality in gastrointestinal Cancer Patients Undergoing Chemotherapy "
Determining the effect of diaphragmatic breathing on anxiety levels and sleep quality in patients with gastrointestinal cancer undergoing chemotherapy
Design
A controlled, double-blind, randomized, parallel-group clinical trial on 62 patients. The randomization method in this study was based on a block design with a block size of four and a 1:1 distribution of participants, using a sequence generated by RAS.
Settings and conduct
This study is a randomized controlled clinical trial study conducted to investigate the effect of diaphragmatic breathing training on anxiety levels and sleep quality in patients with gastrointestinal cancer undergoing chemotherapy. The statistical population includes all patients with gastrointestinal cancers who were referred to hospitals affiliated with Arak University of Medical Sciences in 1404 and were undergoing chemotherapy. Due to the obvious nature of the intervention (breathing training), complete blinding of participants and the instructor is not possible. However, data collectors and statistical analysts will be blinded to group allocation to minimize the risk of bias.
Participants/Inclusion and exclusion criteria
Patients aged 18–65 with confirmed gastrointestinal cancer, at least one chemotherapy session, and ability to complete questionnaires are included. Those with severe cardiac/pulmonary disease, major psychiatric disorders, addiction, or inability to perform exercises are excluded. Participants may withdraw if condition worsens or they decline.
Intervention groups
The intervention group receives face-to-face diaphragmatic breathing training plus educational materials and follow-up monitoring. The control group receives routine oncology care only.
Main outcome variables
Sleep quality: Obtained through the Pittsburgh Sleep Quality Index.
Anxiety: A score obtained through the Spielberger State Anxiety Inventory.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260122068638N1
Registration date:2026-02-25, 1404/12/06
Registration timing:registered_while_recruiting
Last update:2026-02-25, 1404/12/06
Update count:0
Registration date
2026-02-25, 1404/12/06
Registrant information
Name
Hannie Varvani
Name of organization / entity
The university of khomein
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 6085
Email address
hannievarvani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-29, 1404/11/09
Expected recruitment end date
2026-05-30, 1405/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"Investigating the Effects of Diaphragmatic Breathing Training on Anxiety and Sleep Quality in gastrointestinal Cancer Patients Undergoing Chemotherapy "
Public title
"Investigating the Effects of Diaphragmatic Breathing Training on Anxiety and Sleep Quality in gastrointestinal Cancer Patients Undergoing Chemotherapy "
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients will be eligible to enter the research if the definitive diagnosis of digestive tract cancer is registered in their medical records and confirmed by a specialist doctor
The age of the patients should be between 18 and 65 years, so that they are physiologically within the range that can be expected to respond to breathing exercises
Patients must have a sufficient level of consciousness and cognitive ability to understand the instructions and perform the breathing exercises correctly
Fluency in Persian language is required to complete the questionnaires and answer accurately
Willingness and written informed consent to cooperate in research
Patients must have completed at least one course of chemotherapy so that their clinical conditions are relatively stable
Exclusion criteria:
Patients who are unable to participate in this study due to clinical conditions or individual characteristics will not be included in the inclusion group. This category includes patients who have severe heart or lung diseases, and this condition can prevent breathing exercises safely.
Patients with a history of severe psychiatric disorders such as diagnosed severe depression or anxiety, or those dependent on sedatives, hypnotics, or addictive substances, will not be eligible for entry.
Patients with cognitive or physical limitations that prevent them from performing exercises or completing questionnaires will not be included in the study from the beginning due to ethical and scientific considerations.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is based on block design with a block size of four and distribution of participants as 1:1 and by the sequence produced with RAS. This method ensures that the number of samples in both intervention and control groups always remains balanced during the process of recruiting patients. The random allocation sequence will be generated by an independent researcher who has no involvement in the recruitment, training, or assessment of patients, and this sequence will be placed in opaque, sealed, and numbered envelopes. When each patient enters, the envelope corresponding to the sequence number is opened and the patient is assigned to the intervention or control group based on the code inside.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the open nature of the intervention (breathing exercise), complete blinding of the participants and trainer is not possible. However, data collectors and statistical analysts will be blinded to group allocation to minimize the risk of bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
---
Secondary trial Id
--
Registration date
2026-01-23, 1404/11/03
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of khomein University of Medical Sciences
Street address
Arak.,qods blvd.,banoo street.,ensaf8 alley
City
Arak
Province
Markazi
Postal code
3818648764
Approval date
2026-01-11, 1404/10/21
Ethics committee reference number
IR.KHOMEIN.REC.1404.036
Health conditions studied
1
Description of health condition studied
gastrointestinal Cancer
ICD-10 code
C15-C26
ICD-10 code description
Malignant neoplasms of digestive organs
Primary outcomes
1
Description
Anxiety and Sleep Quality in gastrointestinal Cancer Patients Undergoing Chemotherapy
Timepoint
At the beginning of the study (before the intervention) and 14 days after the start of diaphragmatic breathing
Intervention group: The research intervention in the experimental group includes training and implementation of diaphragmatic breathing exercises. Initial training will be conducted in person and face-to-face by the researcher, and an educational brochure, video, and audio file will be provided to the patients to reinforce learning. Each training session will last 10 minutes, and patients will be required to perform it twice a day (9 am and 9 pm) for 14 consecutive days. The first training session will be conducted under the supervision of the researcher to ensure that the patient has learned the method correctly. Then, the patients will continue the exercises independently, and their adherence will be monitored through daily records and telephone calls.
Category
N/A
2
Description
Control group: They will only receive routine oncology care and will not receive any specific breathing training or exercises.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
khansari hospital
Full name of responsible person
Hannie Varvani
Street address
qods blvd
City
Arak
Province
Markazi
Postal code
38188648764
Phone
+98 86 3366 6085
Email
hannievarvani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of khomein
Full name of responsible person
Dr Jafar Karami
Street address
azadi street
City
khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 4142
Email
info@khomeinums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of khomein
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
The University of khomein
Full name of responsible person
Hannie varvani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
banoo street
City
Arak
Province
Markazi
Postal code
381868764
Phone
+98 86 3366 6085
Email
hannnievarvani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Khomein
Full name of responsible person
Hannie varvani
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
banoo street
City
Arak
Province
Markazi
Postal code
3818648764
Phone
0098863366085
Email
hannievarvani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of khomein
Full name of responsible person
hannie varvani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
banoo street
City
Arak
Province
Markazi
Postal code
3818648764
Phone
+98 86 3366 6085
Email
hannievarvani@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