TransplantationNCT07067580
Effect of Breathing Exercise on Pain and Quality of Recovery in After Transplantation Patients: A Randomized Controlled Trial
A study testing respiratory exercise in people with Transplantation and Pain Management, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The researchers will fill out the "Patient Introduction Form" for the patients who agreed to participate in the study after obtaining permission from the experimental group with the "Informed Consent Form" the day before the surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transplantation, Pain Management, Quality of Recovery 40
- What is being tested?
- respiratory exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over, 65 and under,
- Those who have had a transplant for the first time,
- Patients who volunteer to participate in the study will be included in the study.
Who cannot join
- Hemodynamically unstable,
- Those who may experience physical strain during breathing exercises and have a disease that may cause increased intra-abdominal pressure (e.g. bleeding hemorrhoids, hernias of all kinds, persistent cough, severe back pain, heart diseases, high blood pressure, urinary incontinence, epilepsy),
- Those with early complications
- Those with neurological or psychological problems,
- Those who were transferred to the intensive care unit after surgery,
- Emergency and unplanned cases will be excluded from the scope of the research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yıldırım Beyazıt University
Ankara
Tuba Yılmazer, PhD, 05079552804, tyilmazer@aybu.edu.tr
About this study
The researchers will fill out the "Patient Introduction Form" for the patients who agreed to participate in the study after obtaining permission from the experimental group with the "Informed Consent Form" the day before the surgery. The breathing exercises will be taught and monitored by the researchers, and the researcher who will implement them is a nurse in the general surgery department. The experimental group will be trained on breathing exercises by the researcher the day before the surgery. The patients will be provided with 1 set (4 breaths) per hour of breathing exercises after the surgery. The patient's vital signs will be monitored before and after the breathing exercise. Patients will not have difficulty during the breathing exercise, and they will be provided with gradual interventions. Pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay. The recovery quality scale will be applied on the 1st and 3rd day after surgery. In the control group, after obtaining permission with the "Informed Consent Form" the day before the surgery, the patients who agreed to participate in the study will fill out the "Patient Introduction Form" by the researchers, and their pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay after the surgery. The recovery quality scale will be applied on the 1st and 3rd day after surgery. No intervention will be made to the patients in the control group, and they will be provided with routine nursing care provided in the hospital.
- Conditions
- Transplantation, Pain Management, Quality of Recovery 40
- Being tested
- respiratory exercise
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory exerciseOther
The experimental group will be trained on respiratory exercises by the researcher the day before the surgery. The patients will be asked to perform the post-operative respiratory exercises as 1 set (4 breaths) per hour. The patient's vital signs will be monitored before and after the respiratory exercise. Patients will not have difficulty during the respiratory exercise, they will be asked to do it gradually.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | After obtaining permission from the experimental group with the "Informed Consent Form" the day before the surgery, the patients who agree to participate in the study will fill out the "Patient Introduction Form" by the researchers. The respiratory exercises will be taught and monitored by the researchers, and the researcher who will perform them works as a nurse in the general surgery department. The experimental group will be trained on respiratory exercises by the researcher the day before the surgery. The patients will be asked to perform the post-operative respiratory exercises as 1 set (4 breaths) per hour. The patient's vital signs will be monitored before and after the respiratory exercise. Patients will not have difficulty during the respiratory exercise, they will be asked to do it gradually. Pain conditions will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay. The recovery quality scale will be applied on the 1st and 3rd days after the surgery. Receives: Other: respiratory exercise |
| Control | No intervention | In the control group, after obtaining permission with the "Informed Consent Form" the day before the surgery, the patients who agreed to participate in the study will fill out the "Patient Introduction Form" by the researchers, and their pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay after the surgery. The quality of recovery scale will be applied on the 1st and 3rd days after the surgery. No intervention will be made to the patients in the control group, and they will receive routine nursing care provided in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
The scale consists of a 10 cm long horizontal line and the score is determined by measuring the distance between the leftmost end of the scale and the point marked by the patient. The score range from 0 to 10 on this scale and higher scores indicate increased pain severity.
Measured: postoperative 2,6,12,24 hours
Quality of Recovery-40
It was developed by Myles et al. (2000) and its Turkish validity and reliability were conducted by Karaman et al. (2014). The questionnaire consists of 40 items and five sub-dimensions as 'Emotional State, Physical Comfort, Patient Support, Physical Independence, and Pain'. Each item in the questionnaire is scored on a Likert-type scale ranging from 1 to 5. This classification is as follows: 1= Never, 2= Sometimes, 3= Usually, 4= Most of the time, 5= Always. The total score obtained from the scale varies between 40 and 200. An increase in the score obtained from the questionnaire indicates that the physical and emotional well-being of the patients increases in the postoperative period; a decrease indicates that the physical and emotional well-being of the patients is negatively affected (Myles et al. 2000; Karaman et al. 2014). The Cronbach's alpha coefficient of the questionnaire was determined as 0.936 (Karaman et al. 2014).
Measured: postoperative 1 and 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Aug 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantationStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Yılmazer, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067580
- Sponsor's protocol ID
- transplantationsurgery
- Status last verified
- Dec 2025
- First submitted
- 6 Jul 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Exercise on Pain and Quality of Recovery in After Transplantation Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07067580
- Acronym / sponsor ID
- transplantationsurgery
- Conditions
- Transplantation, Pain Management, Quality of Recovery 40
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 16 Jul 2025 (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.
The researchers will fill out the "Patient Introduction Form" for the patients who agreed to participate in the study after obtaining permission from the experimental group with the "Informed Consent Form" the day before the surgery. The breathing exercises will be taught and monitored by the researchers, and the researcher who will implement them is a nurse in the general surgery department. The experimental group will be trained on breathing exercises by the researcher the day before the surgery. The patients will be provided with 1 set (4 breaths) per hour of breathing exercises after the surgery. The patient's vital signs will be monitored before and after the breathing exercise. Patients will not have difficulty during the breathing exercise, and they will be provided with gradual interventions. Pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay. The recovery quality scale will be applied on the 1st and 3rd day after surgery. In the control group, after obtaining permission with the "Informed Consent Form" the day before the surgery, the patients who agreed to participate in the study will fill out the "Patient Introduction Form" by the researchers, and their pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay after the surgery. The recovery quality scale will be applied on the 1st and 3rd day after surgery. No intervention will be made to the patients in the control group, and they will be provided with routine nursing care provided in the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: respiratory exerciseAfter obtaining permission from the experimental group with the "Informed Consent Form" the day before the surgery, the patients who agree to participate in the study will fill out the "Patient Introduction Form" by the researchers. The respiratory exercises will be taught and monitored by the researchers, and the researcher who will perform them works as a nurse in the general surgery department. The experimental group will be trained on respiratory exercises by the researcher the day before the surgery. The patients will be asked to perform the post-operative respiratory exercises as 1 set (4 breaths) per hour. The patient's vital signs will be monitored before and after the respiratory exercise. Patients will not have difficulty during the respiratory exercise, they will be asked to do it gradually. Pain conditions will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay. The recovery quality scale will be applied on the 1st and 3rd days after the surgery. |
| Control | No intervention | –In the control group, after obtaining permission with the "Informed Consent Form" the day before the surgery, the patients who agreed to participate in the study will fill out the "Patient Introduction Form" by the researchers, and their pain status will be monitored at 0, 2, 6, 12 and 24 hours during the 24-hour hospital stay after the surgery. The quality of recovery scale will be applied on the 1st and 3rd days after the surgery. No intervention will be made to the patients in the control group, and they will receive routine nursing care provided in the hospital. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 and over, 65 and under,
- Those who have had a transplant for the first time,
- Patients who volunteer to participate in the study will be included in the study.
Key exclusion criteria (6 listed)
- Hemodynamically unstable,
- Those who may experience physical strain during breathing exercises and have a disease that may cause increased intra-abdominal pressure (e.g. bleeding hemorrhoids, hernias of all kinds, persistent cough, severe back pain, heart diseases, high blood pressure, urinary incontinence, epilepsy),
- Those with early complications
- Those with neurological or psychological problems,
- Those who were transferred to the intensive care unit after surgery,
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 |
|---|---|---|
| respiratory exerciseThe experimental group will be trained on respiratory exercises by the researcher the day before the surgery. The patients will be asked to perform the post-operative respiratory exercises as 1 set (4 breaths) per hour. The patient's vital signs will be monitored before and after the respiratory exercise. Patients will not have difficulty during the respiratory exercise, they will be asked to do it gradually. | Other | Experimental |
Primary outcome
visual analog scale
Time frame: postoperative 2,6,12,24 hours
The scale consists of a 10 cm long horizontal line and the score is determined by measuring the distance between the leftmost end of the scale and the point marked by the patient. The score range from 0 to 10 on this scale and higher scores indicate increased pain severity.
Quality of Recovery-40
Time frame: postoperative 1 and 3 days
It was developed by Myles et al. (2000) and its Turkish validity and reliability were conducted by Karaman et al. (2014). The questionnaire consists of 40 items and five sub-dimensions as 'Emotional State, Physical Comfort, Patient Support, Physical Independence, and Pain'. Each item in the questionnaire is scored on a Likert-type scale ranging from 1 to 5. This classification is as follows: 1= Never, 2= Sometimes, 3= Usually, 4= Most of the time, 5= Always. The total score obtained from the scale varies between 40 and 200. An increase in the score obtained from the questionnaire indicates that the physical and emotional well-being of the patients increases in the postoperative period; a decrease indicates that the physical and emotional well-being of the patients is negatively affected (Myles et al. 2000; Karaman et al. 2014). The Cronbach's alpha coefficient of the questionnaire was determined as 0.936 (Karaman et al. 2014).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing respiratory exercise in people with Transplantation and Pain Management, run by Ankara Yildirim Beyazıt 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Yilmazer, PhD (5079552804, tyilmazer@aybu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (time frame: postoperative 2,6,12,24 hours). The study lists 2 primary outcomes in all. 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 15 Dec 2025.