CaregiverNCT05988320
The Effect of Pranayama Breathing Exercise on Fatigue in Cancer Patient Caregivers
A study testing Pranayama breathing exercise in people with Caregiver and Fatigue, 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 caregivers of cancer patients on fatigue. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2023to 10 Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Above 18 years old 2. Able to read and write 3. Having sufficient communication skills 4. Does not have any ailment that will reduce the ability to grasp and understand 5. Giving active care to inpatients in the clinic 6. Able to use smart mobile phone 7. Caregivers who agree to participate in the study will be included in the study.
Who cannot join
- 1. Having a chronic disease 2. Caregivers using opioids or sedating drugs will not be included in the study.
- 3. Using integrated health practices in the treatment process 4. Patients who exercise regularly will not be included in the study.
- Research Termination Criteria
- Intervention Group
- Developing health problems
- Unwilling to continue Pranayama practice
Show all 11Show fewer
- Not practicing pranayama as recommended or unable to do it effectively,
- The study will be terminated with patients who want to withdraw from the study.
- Control Group
- Developing health problems
- 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 Fatigue of the Cancer Patient Caregiver Who Applied Pranayama Breathing Exercise and no Application
This research is a randomized controlled experimental study to determine the effect of pranayama breathing exercise applied to caregivers of cancer patients on fatigue.
Read the detailed description
METHODST: The research will be carried out at Erciyes University Health Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital located in Kayseri city center.
Population and Sample of the Research: The population of the research will be the caregivers of the patients hospitalized in the medical oncology clinic of Erciyes University Health Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.
Sample of the Research: It was calculated by performing power analysis for the sample of the research. In the article titled "Evaluation of fatigue and sleep quality of caregivers of advanced cancer patients", the minimum sample size per group was 22 when the calculation was made as alpha=0.05 and power=0.80, taking into account the pretest-posttest fatigue score averages of the caregivers. It is planned to take 30 people per group Data Collection Form and Tools: The data of the study will be collected through the Caregiver Information Form, Piper Fatigue Scale, Informed Voluntary Consent Form, Eastern Cooperative Oncology Group (for the patient) Performance Scale forms.
Data Collection: Ethics committee, institutional permission and scale usage permission were obtained for the data of the study. Intervention and control group selection in the study will be collected by minimization randomization. The data will be collected by the researcher himself by face-to-face interview method. The intervention group will be given pranayama training. The post-test will be done four weeks after both groups are pre-tested.
Pre-Test: . After informing the caregivers of cancer patients in the Medical Oncology clinic about the research and obtaining verbal and written consent from the researcher, the caregiver introduction form and Piper fatigue scale will be applied to the experimental and control groups, respectively.
Post-Test: The piper fatigue scale will be re-administered to the individuals in both groups by the same researcher four weeks after the pre-test, and one day after the pranayama breathing exercise in the control group and experimental group.
- Being tested
- Pranayama breathing exercise
- Keywords
- CAREGİVER, CANCER, PRANAYAMA, FATİGUE
- Medical subject headings
- Fatigue, 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 |
|---|---|---|
| Experimental: Applications to the Intervention Group | Experimental | Pranayama breathing will be performed by the caregivers of cancer patients in the Medical Oncology clinic for a total of 4 weeks, covering 15-20 minutes every day, for a total of 4 weeks. information will be given about the benefits and benefits, and any questions will be answered. The application steps will be repeated both by explaining and showing, until the caregiver learns, and if there are any points that they cannot do, they will be corrected. When the caregivers are observed to perform the application fully, they will be asked to do the pranayama breathing exercise every day for 4 weeks and will provide the effectiveness and continuity of the application by providing the same researcher 3 days a week (Tuesday, Thursday, Saturday) with a smartphone WhatsApp video call. Receives: Procedure: Pranayama breathing exercise |
| Applications to the Control Group | No intervention | Only the pre-test will be applied to the caregivers of cancer patients in the Medical Oncology clinic in the control group. After the caregiver introduction form and Piper fatigue scale application, no breathing exercises will be performed. Individuals will continue their daily lives. Four weeks later the Piper fatigue scale will be administered again. After the Piper fatigue scale is applied, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue of cancer caregivers
Measuring the fatigue of cancer patient caregivers before and after four weeks of training
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 start18 Mar 2023
- Primary completion20 Oct 2023
- Study completion10 Nov 2023
Why it stopped: Data from this study collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies 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
- The caregivers of the patients hospitalized in the medical oncology clinic of the Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital will be formed. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.It is planned to take 30 people per group and 60 people in total.
- Masking
- None (open label)
- Enrolment
- 62 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
- NCT05988320
- Sponsor's protocol ID
- SANKOU-HEM-ZD-02
- Status last verified
- May 2025
- First submitted
- 4 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 Fatigue of the Cancer Patient Caregiver Who Applied Pranayama Breathing Exercise and no Application
- ClinicalTrials.gov ID
- NCT05988320
- Acronym / sponsor ID
- SANKOU-HEM-ZD-02
- Keywords
- CAREGİVER, CANCER, PRANAYAMA, FATİGUE
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data from this study collected
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 10 Nov 2023 (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 caregivers of cancer patients on fatigue.
Detailed description
METHODST: The research will be carried out at Erciyes University Health Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital located in Kayseri city center.
Population and Sample of the Research: The population of the research will be the caregivers of the patients hospitalized in the medical oncology clinic of Erciyes University Health Practice and Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.
Sample of the Research: It was calculated by performing power analysis for the sample of the research. In the article titled "Evaluation of fatigue and sleep quality of caregivers of advanced cancer patients", the minimum sample size per group was 22 when the calculation was made as alpha=0.05 and power=0.80, taking into account the pretest-posttest fatigue score averages of the caregivers. It is planned to take 30 people per group Data Collection Form and Tools: The data of the study will be collected through the Caregiver Information Form, Piper Fatigue Scale, Informed Voluntary Consent Form, Eastern Cooperative Oncology Group (for the patient) Performance Scale forms.
Data Collection: Ethics committee, institutional permission and scale usage permission were obtained for the data of the study. Intervention and control group selection in the study will be collected by minimization randomization. The data will be collected by the researcher himself by face-to-face interview method. The intervention group will be given pranayama training. The post-test will be done four weeks after both groups are pre-tested.
Pre-Test: . After informing the caregivers of cancer patients in the Medical Oncology clinic about the research and obtaining verbal and written consent from the researcher, the caregiver introduction form and Piper fatigue scale will be applied to the experimental and control groups, respectively.
Post-Test: The piper fatigue scale will be re-administered to the individuals in both groups by the same researcher four weeks after the pre-test, and one day after the pranayama breathing exercise in the control group and experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The caregivers of the patients hospitalized in the medical oncology clinic of the Research Center Mehmet Kemal Dedeman Hematology - Oncology Hospital will be formed. Cancer patient caregivers who meet the inclusion criteria of the study and volunteer to participate in the study will constitute the sample of the study.It is planned to take 30 people per group and 60 people in total.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Applications to the Intervention Group | Experimental | Procedure: Pranayama breathing exercisePranayama breathing will be performed by the caregivers of cancer patients in the Medical Oncology clinic for a total of 4 weeks, covering 15-20 minutes every day, for a total of 4 weeks. information will be given about the benefits and benefits, and any questions will be answered. The application steps will be repeated both by explaining and showing, until the caregiver learns, and if there are any points that they cannot do, they will be corrected. When the caregivers are observed to perform the application fully, they will be asked to do the pranayama breathing exercise every day for 4 weeks and will provide the effectiveness and continuity of the application by providing the same researcher 3 days a week (Tuesday, Thursday, Saturday) with a smartphone WhatsApp video call. |
| Applications to the Control Group | No intervention | –Only the pre-test will be applied to the caregivers of cancer patients in the Medical Oncology clinic in the control group. After the caregiver introduction form and Piper fatigue scale application, no breathing exercises will be performed. Individuals will continue their daily lives. Four weeks later the Piper fatigue scale will be administered again. After the Piper fatigue scale is applied, pranayama breathing exercise training will be given to all control group patients and they will be applied for 2 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Above 18 years old 2. Able to read and write 3. Having sufficient communication skills 4. Does not have any ailment that will reduce the ability to grasp and understand 5. Giving active care to inpatients in the clinic 6. Able to use smart mobile phone 7. Caregivers who agree to participate in the study will be included in the study.
Key exclusion criteria (11 listed)
- 1. Having a chronic disease 2. Caregivers using opioids or sedating drugs will not be included in the study.
- 3. Using integrated health practices in the treatment process 4. Patients who exercise regularly will not be included in the study.
- Research Termination Criteria
- Intervention Group
- Developing health problems
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 | Experimental: Applications to the Intervention Group |
Primary outcome
fatigue of cancer caregivers
Time frame: four weeks
Measuring the fatigue of cancer patient caregivers before and after four weeks of training
Results and safety
The study was stopped early (reason given: Data from this study collected). Results are not available in the source record.
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 Caregiver and Fatigue, 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 1 inclusion and 11 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: stopped early, 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 was stopped early (reason given: Data from this study collected). Results are not available in the source record.
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?
fatigue of cancer caregivers (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.