Effect of Breathing Exercise on Pain and Quality of Recovery in After Transplantation Patients: A Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2025
CompletedFirst Posted
Study publicly available on registry
July 16, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedDecember 15, 2025
December 1, 2025
8 months
July 6, 2025
December 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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).
postoperative 1 and 3 days
Study Arms (2)
Experimental
EXPERIMENTALAfter 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 INTERVENTIONIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Yıldırım Beyazıt University
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 6, 2025
First Posted
July 16, 2025
Study Start
August 1, 2025
Primary Completion
March 31, 2026
Study Completion
April 30, 2026
Last Updated
December 15, 2025
Record last verified: 2025-12