Lung CancerNCT05985824
The Effect of Pranayama Breathing Exercise on Quality of Life in Lung Cancer Patients
A study testing Pranayama breathing exercise in people with Lung Cancer, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
This research is a randomized controlled experimental study to determine the effect of pranayama breathing exercise applied to patients with lung cancer on quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Pranayama breathing exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2023to 27 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Lung Cancer Stage III and IV,
- Being literate,
- Having sufficient communication skills,
- Does not have any ailment that will reduce the ability to comprehend and understand,
- Agreeing to participate in the research,
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- Knowing the diagnosis,
- Receiving chemotherapy treatment,
- ECOG performance score ≤ 2,
- Not using opioids or sedating drugs,
- Patients who can use smart phones themselves or their relatives will be included in the study
Who cannot join
- Lung Cancer I., II., stage,
- Receiving radiotherapy,
- Having a history of Brain Metastasis,
- Using integrated health practices in the treatment process,
- Those who exercise regularly
- For patients over 65 years of age, patients with a score below 24 on the mini mental test were not included in the study.
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- Research Termination Criteria
- Intervention Group
- Developing additional health problems,
- Unwilling to continue the practice of pranayama breathing exercise,
- Those who lost their lives during the research process,
- Those who do not practice pranayama breathing exercise as recommended or cannot do it effectively,
- The study will be terminated with patients who want to withdraw from the study.
- Control Group
- Developing additional health problems,
- Those who lost their lives during the research process,
- The study will be terminated with patients who want to withdraw from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect on the Quality of Life of Lung Cancer Patients Who Underwent Prnayama Breathing Exercise and Did Not Apply Any Exercise.
This research is a randomized controlled experimental study to determine the effect of pranayama breathing exercise applied to patients with lung cancer on quality of life.
Read the detailed description
The population of the study consists of patients with primary diagnosis of lung cancer who applied to Erciyes University Health Practice and Research Center Nazende-Nuri Özkaya Oncology Day Treatment Center. Patients with primary diagnosis of lung cancer who met the inclusion criteria of the study and volunteered to participate in the study will constitute the sample of the study. It was calculated by performing power analysis for the sample of the study. In the power analysis made according to the effect size of the research; When calculating the partial eta square effect size of 0.06, alpha=0.05 and power=0.80 for two-way ANOVA in repeated measurements, the sample size per group is 35. A total of 70 people will be sampled. Data Collection Form and Tools: The data of the study are collected through Personal Information Form, European Cancer Research and Treatment Organization Quality of Life Scale 3rd Version, Informed Voluntary Consent Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale, Mini Mental Test forms. The data of the research were obtained from the academic committee, ethics committee and institution of Erciyes University Faculty of Health Sciences. Patients who accept the study are pre-tested. Patient selection for the intervention and control groups of the study is made using the minimization randomization method. In the minimization method, the patients are assigned to groups according to age, gender, cancer cell type, cancer stage, duration and having a chronic disease. Data are collected from lung cancer patients who accepted to participate in the study, who applied to the outpatient chemotherapy unit by using face-to-face interview method by the researcher herself. During the study, the routine treatments of the patients in the intervention and control groups will not be interfered with.
Pre-Test: The patients with lung cancer who applied to the outpatient chemotherapy unit are informed about the research by the researcher and after obtaining the consent form, the personal information form and the quality of life scale are applied to the intervention and control groups by using the face-to-face interview method and the records obtained from the patient files, respectively.
Applications to the Intervention Group: Among the pranayama breathing exercises, only the Nadi Shothana technique will be applied to lung cancer patients who apply to the outpatient chemotherapy unit. This exercise will be done every day for 4 weeks, covering 15-20 minutes. After applying the personal information form and quality of life scale to the patients, the researcher will be informed about what the pranayama exercise is, its importance, purpose and benefits. Patients will be given an application guide and their questions will be answered if they have any. In patient education, the pranayama breathing exercise will be applied face-to-face by the researcher on the first day of chemotherapy treatment, before drug treatment. The application steps will be repeated until the patient learns, both by explaining and showing the patient, and if there are points that the patient cannot do, they will be corrected. When the patients are observed to perform the application fully and the chemotherapy treatments are finished, they will be asked to do the pranayama breathing exercise every day for 4 weeks, and with the same researcher 3 days a week (Monday, Wednesday, Saturday) with a smart phone whatsapp video call, the effectiveness and continuity of the application will be ensured and the patients will be monitored. If the patients assigned to the intervention group are unable to perform the application or have difficulties, the study with these patients will be terminated.
Applications to the Control Group: After the application of the personal information form and the quality of life scale, no breathing exercises will be performed. Individuals will continue their daily lives. After 4 weeks, the quality of life scale will be administered again. After the implementation of the quality of life scale, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.
Post-Test: The quality of life scale will be re-administered to the patients in both groups by the same researcher 4 weeks after the pre-test, and one day after the pranayama breathing exercise application to the control group and intervention group.
- Conditions
- Lung Cancer
- Being tested
- Pranayama breathing exercise
- Keywords
- Lung cancer, Pranayama, Quality of Life, Nursing
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama breathing exerciseProcedure or surgery
Pranayama is an important step in yoga, way of life, and is translated as "the science of breathing, breath control, willful breathing". This alternating breathing-out action also balances the sympathetic and parasympathetic nervous systems, giving the person a state of calm, providing relaxation and positively affecting fatigue. Application steps; Right hand Nasika mudra is performed. Nasika mudra is the mudra where the second and third fingers of the right hand are folded into the palm and the other fingers are exposed. Then the right nostril is closed with the first finger of the right hand. Start by breathing through the left nostril. Then the left nostril is closed with the fourth finger and the breath is held. While the left nostril is closed, the right nostril is opened and inhaled. Breathe again through
| Study group | Role | What they receive |
|---|---|---|
| Applications to the Intervention Group | Experimental | Patients with lung cancer admitted to the outpatient chemotherapy unit will be given pranayama breathing exercises every day for 4 weeks, covering 15-20 minutes. In patient education, the pranayama breathing exercise will be applied face-to-face by the researcher on the first day of chemotherapy treatment, before drug treatment. The application steps will be repeated until the patient learns, both by explaining and showing the patient, and if there are points that the patient cannot do, they will be corrected. When the patients are observed to perform the application fully and the chemotherapy treatments are finished, they will be asked to do the pranayama breathing exercise every day for 4 weeks, and with the same researcher 3 days a week (Monday, Wednesday, Saturday) with a smart phone whatsapp video call, the effectiveness and continuity of the application will be ensured and the patients will be monitored. Receives: Procedure: Pranayama breathing exercise |
| Applications to the Control Group | No intervention | A pre-test will be applied to lung cancer patients in the control group who applied to the day chemotherapy unit. After the application of the personal information form and the quality of life scale, no breathing exercises will be performed. Individuals will continue their daily lives. After 4 weeks, the quality of life scale will be administered again. After the implementation of the quality of life scale, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.(The study will begin before the patients in both the experimental and control groups receive chemotherapy, which is their routine treatment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of lung cancer patients
European Organization for Cancer Research and Treatment Quality of Life Scale :measure lung cancer patients before and four weeks aftter. European Organization for Cancer Research and Treatment Quality of Life Scale: scale consists of 3 sub-titles: general well-being, functional area and symptom control. While the maximum score that patients will get from these three sub-headings is 100, the minimum score is 0. The first 28 questions are questions related to the functional area and symptom control subheadings, and low scores on these questions mean high quality of life, and high scores mean low quality of life. The last two questions belong to the sub-heading of general well-being, and a low score on these questions indicates a low quality of life, and a high score indicates a high quality of life.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Jan 2023
- Primary completion27 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with primary diagnosis of lung cancer who met the inclusion criteria of the study and volunteered to participate in the study will constitute the sample of the study. 35 per group for the sample of the study. A total of 70 people will be sampled.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Doğan, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985824
- Sponsor's protocol ID
- SANKOU-HEM-ZD-01
- Status last verified
- May 2025
- First submitted
- 1 Aug 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to share it after it is ready for publication.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect on the Quality of Life of Lung Cancer Patients Who Underwent Prnayama Breathing Exercise and Did Not Apply Any Exercise.
- ClinicalTrials.gov ID
- NCT05985824
- Acronym / sponsor ID
- SANKOU-HEM-ZD-01
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Pranayama, Quality of Life, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is a randomized controlled experimental study to determine the effect of pranayama breathing exercise applied to patients with lung cancer on quality of life.
Detailed description
The population of the study consists of patients with primary diagnosis of lung cancer who applied to Erciyes University Health Practice and Research Center Nazende-Nuri Özkaya Oncology Day Treatment Center. Patients with primary diagnosis of lung cancer who met the inclusion criteria of the study and volunteered to participate in the study will constitute the sample of the study. It was calculated by performing power analysis for the sample of the study. In the power analysis made according to the effect size of the research; When calculating the partial eta square effect size of 0.06, alpha=0.05 and power=0.80 for two-way ANOVA in repeated measurements, the sample size per group is 35. A total of 70 people will be sampled. Data Collection Form and Tools: The data of the study are collected through Personal Information Form, European Cancer Research and Treatment Organization Quality of Life Scale 3rd Version, Informed Voluntary Consent Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale, Mini Mental Test forms. The data of the research were obtained from the academic committee, ethics committee and institution of Erciyes University Faculty of Health Sciences. Patients who accept the study are pre-tested. Patient selection for the intervention and control groups of the study is made using the minimization randomization method. In the minimization method, the patients are assigned to groups according to age, gender, cancer cell type, cancer stage, duration and having a chronic disease. Data are collected from lung cancer patients who accepted to participate in the study, who applied to the outpatient chemotherapy unit by using face-to-face interview method by the researcher herself. During the study, the routine treatments of the patients in the intervention and control groups will not be interfered with.
Pre-Test: The patients with lung cancer who applied to the outpatient chemotherapy unit are informed about the research by the researcher and after obtaining the consent form, the personal information form and the quality of life scale are applied to the intervention and control groups by using the face-to-face interview method and the records obtained from the patient files, respectively.
Applications to the Intervention Group: Among the pranayama breathing exercises, only the Nadi Shothana technique will be applied to lung cancer patients who apply to the outpatient chemotherapy unit. This exercise will be done every day for 4 weeks, covering 15-20 minutes. After applying the personal information form and quality of life scale to the patients, the researcher will be informed about what the pranayama exercise is, its importance, purpose and benefits. Patients will be given an application guide and their questions will be answered if they have any. In patient education, the pranayama breathing exercise will be applied face-to-face by the researcher on the first day of chemotherapy treatment, before drug treatment. The application steps will be repeated until the patient learns, both by explaining and showing the patient, and if there are points that the patient cannot do, they will be corrected. When the patients are observed to perform the application fully and the chemotherapy treatments are finished, they will be asked to do the pranayama breathing exercise every day for 4 weeks, and with the same researcher 3 days a week (Monday, Wednesday, Saturday) with a smart phone whatsapp video call, the effectiveness and continuity of the application will be ensured and the patients will be monitored. If the patients assigned to the intervention group are unable to perform the application or have difficulties, the study with these patients will be terminated.
Applications to the Control Group: After the application of the personal information form and the quality of life scale, no breathing exercises will be performed. Individuals will continue their daily lives. After 4 weeks, the quality of life scale will be administered again. After the implementation of the quality of life scale, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.
Post-Test: The quality of life scale will be re-administered to the patients in both groups by the same researcher 4 weeks after the pre-test, and one day after the pranayama breathing exercise application to the control group and intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with primary diagnosis of lung cancer who met the inclusion criteria of the study and volunteered to participate in the study will constitute the sample of the study. 35 per group for the sample of the study. A total of 70 people will be sampled.
| Arm | Type | Receives |
|---|---|---|
| Applications to the Intervention Group | Experimental | Procedure: Pranayama breathing exercisePatients with lung cancer admitted to the outpatient chemotherapy unit will be given pranayama breathing exercises every day for 4 weeks, covering 15-20 minutes. In patient education, the pranayama breathing exercise will be applied face-to-face by the researcher on the first day of chemotherapy treatment, before drug treatment. The application steps will be repeated until the patient learns, both by explaining and showing the patient, and if there are points that the patient cannot do, they will be corrected. When the patients are observed to perform the application fully and the chemotherapy treatments are finished, they will be asked to do the pranayama breathing exercise every day for 4 weeks, and with the same researcher 3 days a week (Monday, Wednesday, Saturday) with a smart phone whatsapp video call, the effectiveness and continuity of the application will be ensured and the patients will be monitored. |
| Applications to the Control Group | No intervention | –A pre-test will be applied to lung cancer patients in the control group who applied to the day chemotherapy unit. After the application of the personal information form and the quality of life scale, no breathing exercises will be performed. Individuals will continue their daily lives. After 4 weeks, the quality of life scale will be administered again. After the implementation of the quality of life scale, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions.(The study will begin before the patients in both the experimental and control groups receive chemotherapy, which is their routine treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Over 18 years old,
- Lung Cancer Stage III and IV,
- Being literate,
- Having sufficient communication skills,
- Does not have any ailment that will reduce the ability to comprehend and understand,
Key exclusion criteria (17 listed)
- Lung Cancer I., II., stage,
- Receiving radiotherapy,
- Having a history of Brain Metastasis,
- Using integrated health practices in the treatment process,
- Those who exercise regularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pranayama breathing exercisePranayama is an important step in yoga, way of life, and is translated as "the science of breathing, breath control, willful breathing". This alternating breathing-out action also balances the sympathetic and parasympathetic nervous systems, giving the person a state of calm, providing relaxation and positively affecting fatigue. Application steps; Right hand Nasika mudra is performed. Nasika mudra is the mudra where the second and third fingers of the right hand are folded into the palm and the other fingers are exposed. Then the right nostril is closed with the first finger of the right hand. Start by breathing through the left nostril. Then the left nostril is closed with the fourth finger and the breath is held. While the left nostril is closed, the right nostril is opened and inhaled. Breathe again through | Procedure or surgery | Applications to the Intervention Group |
Primary outcome
Quality of life of lung cancer patients
Time frame: four weeks
European Organization for Cancer Research and Treatment Quality of Life Scale :measure lung cancer patients before and four weeks aftter. European Organization for Cancer Research and Treatment Quality of Life Scale: scale consists of 3 sub-titles: general well-being, functional area and symptom control. While the maximum score that patients will get from these three sub-headings is 100, the minimum score is 0. The first 28 questions are questions related to the functional area and symptom control subheadings, and low scores on these questions mean high quality of life, and high scores mean low quality of life. The last two questions belong to the sub-heading of general well-being, and a low score on these questions indicates a low quality of life, and a high score indicates a high quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No. We plan to share it after it is ready for publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama breathing exercise in people with Lung Cancer, run by Sanko University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life of lung cancer patients (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.