Patients With Total Knee ArthroplastyNCT06912750
4-7-8 Breathing and Teach-Back Method for Pain, Anxiety, and Sleep After Knee Surgery: A Clinical Trial
A study testing 4-7-8 Breathing Exercise with Teach-Back Method in people with Patients With Total Knee Arthroplasty, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA) is a surgical procedure performed to reduce pain and improve quality of life in elderly individuals with knee dysfunction due to osteoarthritis, rheumatoid arthritis, or other knee joint disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients With Total Knee Arthroplasty
- What is being tested?
- 4-7-8 Breathing Exercise with Teach-Back Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are conscious and oriented,
- Able to communicate,
- Age 65 and over,
- No cognitive-mental problems,
- Standard Mini Mental Test (SMMT) score of 24 and above,
- Have not attended a course on breathing exercises and yoga before,
- Patients who agree to participate in the study verbally and in writing
Who cannot join
- Unconscious,
- Unable to communicate,
- Under 65 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Techical University
Erzurum, Erzurum, 25050
About this study
Official title: Effect of 4 7 8 Breathing Exercises With Teach Back Method on Pain Anxiety and Sleep Quality in Patients After Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty (TKA) is a surgical procedure performed to reduce pain and improve quality of life in elderly individuals with knee dysfunction due to osteoarthritis, rheumatoid arthritis, or other knee joint disorders. It is typically preferred in cases of advanced joint damage to help patients regain daily functional abilities. Postoperative rehabilitation is crucial for pain management, mobility, and overall recovery. The Teach-Back method is an effective educational technique that enhances patients' understanding of health information by encouraging them to repeat what they have learned. This approach improves information retention and promotes active participation in treatment, particularly among individuals with low health literacy. Complementary therapies, such as breathing exercises, can help manage common postoperative issues like pain, anxiety, and sleep disturbances. The 4-7-8 breathing technique has been shown to reduce anxiety and enhance sleep quality by regulating oxygen and carbon dioxide exchange. This method involves inhaling for four seconds, holding the breath for seven seconds, and exhaling for eight seconds, promoting physical and psychological relaxation.This study aims to evaluate the effects of 4-7-8 breathing exercises taught using the Teach-Back method on pain, anxiety, and sleep quality in patients undergoing total knee arthroplasty.
Read the detailed description
Total knee arthroplasty (TKA) is a surgical intervention performed to alleviate pain and enhance quality of life in elderly individuals with impaired knee functionality due to osteoarthritis, rheumatoid arthritis, or other knee joint disorders. This procedure is primarily recommended in cases of advanced joint damage and aims to help patients regain their ability to perform daily activities. Postoperative rehabilitation plays a critical role in pain management, mobility improvement, and overall health recovery. The Teach-Back method is an effective educational strategy designed to enhance patients' comprehension of health-related information. This method ensures that patients accurately retain the information provided by healthcare professionals by requiring them to reiterate the learned content, thereby fostering active participation in their treatment process. Studies have demonstrated that this approach significantly improves information retention, particularly among individuals with low health literacy. Complementary therapies have been shown to be effective in managing common postoperative complications such as pain, anxiety, and sleep disturbances following TKA. Breathing exercises, in particular, have been found to reduce anxiety and improve sleep quality. Teaching breathing exercises through the Teach-Back method may contribute positively to the rehabilitation process by promoting both physical and psychological well-being. One such technique, the 4-7-8 breathing exercise, has been evidenced to aid in reducing anxiety and enhancing sleep quality. This technique involves inhaling for four seconds, holding the breath for seven seconds, and exhaling for eight seconds. By optimizing oxygen intake and facilitating the expulsion of carbon dioxide, this practice supports physiological and psychological relaxation. This study aims to evaluate the effects of 4-7-8 breathing exercises taught using the Teach-Back method on pain, anxiety, and sleep quality in patients undergoing total knee arthroplasty.
- Conditions
- Patients With Total Knee Arthroplasty
- Being tested
- 4-7-8 Breathing Exercise with Teach-Back Method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 Breathing Exercise with Teach-Back MethodOther
In the experimental group, patients will be provided with information regarding the purpose and significance of the 4-7-8 breathing technique using the Teach-Back method one day before surgery. To confirm comprehension, patients will be asked to repeat the information. The exercise will be demonstrated in a one-on-one session using the Teach-Back method, and patients will be guided through practical application. Following the training, patients will be instructed to perform the exercise independently, with the researcher monitoring its correct implementation. Each patient will be given a "4-7-8 Breathing Exercise Application Guide," which outlines the exercise steps based on relevant literature.
Before surgery, patients will complete the "Patient Information Form," the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI), and the Richards-Campbell Sleep Questionnaire (RCSQ). Postoperatively, the VAS and STAI will be administered both before (pre-test) and after
| Study group | Role | What they receive |
|---|---|---|
| 4-7-8 Breathing Exercise with Teach-Back Method | Experimental | Not described Receives: Other: 4-7-8 Breathing Exercise with Teach-Back Method |
| Standard Postoperative Care | No intervention | In the control group, patients will complete the "Patient Information Form," the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI), and the Richards-Campbell Sleep Questionnaire (RCSQ) before undergoing total knee arthroplasty, without any additional interventions beyond standard clinical protocols. Postoperatively, the VAS and STAI will be administered at the 6th, 12th, and 24th hours without any interventions. Following these assessments, patients will be asked to remain in a quiet and calm environment for 30 minutes. At the end of this period, the researcher will reassess pain and anxiety levels using the VAS and STAI, and the data will be collected. Additionally, at the 24th postoperative hour, the RCSQ will be administered, marking the conclusion of data collection for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richard Campbell Sleep Quality Scale
This scale evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep and the noise levels in the environment. When filling out the scale, the person is asked to mark the appropriate option for each item on a chart consisting of 6 items, each item being between 0 and 100. The scale is evaluated with the visual analog scale technique. The score between "0-25" from the scale indicates very bad sleep, and the score between "76-100" indicates very good sleep. The total score of the scale is evaluated based on the first 5 items. The 6th item evaluates the noise level in the environment and is not included in the total score evaluation. As a result, it is concluded that the sleep quality of the participants increases as the total score increases.
Measured: 24 hours
State Anxiety Scale
The scale consists of 20 questions that measure state anxiety. The "State Anxiety Scale (STAI FORM TX-I, DKO)" requires the individual to express how he/she feels at a certain moment and under certain conditions. A minimum of 20 and a maximum of 80 points can be obtained from each subscale, with higher scores indicating a higher level of anxiety.
Measured: 24 hours
Visual Comparison Scale
This scale, developed to determine the intensity of pain, is a 10 cm ruler scale with "No Pain" written on one end and "Unbearable Pain" on the other. It consists of numbers divided into equal intervals of one cm between the starting point where there is no pain and the point marked by the patient. In the evaluation of this scale, 0 = no pain, 1-4 = mild pain, 5-6 = moderate pain, 7-8 = severe pain and 10 = unbearable pain
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Feb 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Total Knee ArthroplastyStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Erden, Erzurum Technical University
- Investigators
- Yasemin Erden, Assistant Professor, Study director, Erzurum Technical University Faculty of Helath ScienceTülay Kılınç, Assistant Professor, Principal investigator, Ataturk University Faculty of NursingZeynep Bal, Principal investigator, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912750
- Sponsor's protocol ID
- 02.16.23.01.2025
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be openly shared. However, data may be available upon reasonable request and with appropriate ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 7 8 Breathing Exercises With Teach Back Method on Pain Anxiety and Sleep Quality in Patients After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06912750
- Acronym / sponsor ID
- 02.16.23.01.2025
- Conditions
- Patients With Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Apr 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.
Total knee arthroplasty (TKA) is a surgical procedure performed to reduce pain and improve quality of life in elderly individuals with knee dysfunction due to osteoarthritis, rheumatoid arthritis, or other knee joint disorders. It is typically preferred in cases of advanced joint damage to help patients regain daily functional abilities. Postoperative rehabilitation is crucial for pain management, mobility, and overall recovery. The Teach-Back method is an effective educational technique that enhances patients' understanding of health information by encouraging them to repeat what they have learned. This approach improves information retention and promotes active participation in treatment, particularly among individuals with low health literacy. Complementary therapies, such as breathing exercises, can help manage common postoperative issues like pain, anxiety, and sleep disturbances. The 4-7-8 breathing technique has been shown to reduce anxiety and enhance sleep quality by regulating oxygen and carbon dioxide exchange. This method involves inhaling for four seconds, holding the breath for seven seconds, and exhaling for eight seconds, promoting physical and psychological relaxation.This study aims to evaluate the effects of 4-7-8 breathing exercises taught using the Teach-Back method on pain, anxiety, and sleep quality in patients undergoing total knee arthroplasty.
Detailed description
Total knee arthroplasty (TKA) is a surgical intervention performed to alleviate pain and enhance quality of life in elderly individuals with impaired knee functionality due to osteoarthritis, rheumatoid arthritis, or other knee joint disorders. This procedure is primarily recommended in cases of advanced joint damage and aims to help patients regain their ability to perform daily activities. Postoperative rehabilitation plays a critical role in pain management, mobility improvement, and overall health recovery. The Teach-Back method is an effective educational strategy designed to enhance patients' comprehension of health-related information. This method ensures that patients accurately retain the information provided by healthcare professionals by requiring them to reiterate the learned content, thereby fostering active participation in their treatment process. Studies have demonstrated that this approach significantly improves information retention, particularly among individuals with low health literacy. Complementary therapies have been shown to be effective in managing common postoperative complications such as pain, anxiety, and sleep disturbances following TKA. Breathing exercises, in particular, have been found to reduce anxiety and improve sleep quality. Teaching breathing exercises through the Teach-Back method may contribute positively to the rehabilitation process by promoting both physical and psychological well-being. One such technique, the 4-7-8 breathing exercise, has been evidenced to aid in reducing anxiety and enhancing sleep quality. This technique involves inhaling for four seconds, holding the breath for seven seconds, and exhaling for eight seconds. By optimizing oxygen intake and facilitating the expulsion of carbon dioxide, this practice supports physiological and psychological relaxation. This study aims to evaluate the effects of 4-7-8 breathing exercises taught using the Teach-Back method on pain, anxiety, and sleep quality in patients undergoing total knee arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-7-8 Breathing Exercise with Teach-Back Method | Experimental | Other: 4-7-8 Breathing Exercise with Teach-Back Method |
| Standard Postoperative Care | No intervention | –In the control group, patients will complete the "Patient Information Form," the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI), and the Richards-Campbell Sleep Questionnaire (RCSQ) before undergoing total knee arthroplasty, without any additional interventions beyond standard clinical protocols. Postoperatively, the VAS and STAI will be administered at the 6th, 12th, and 24th hours without any interventions. Following these assessments, patients will be asked to remain in a quiet and calm environment for 30 minutes. At the end of this period, the researcher will reassess pain and anxiety levels using the VAS and STAI, and the data will be collected. Additionally, at the 24th postoperative hour, the RCSQ will be administered, marking the conclusion of data collection for the control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are conscious and oriented,
- Able to communicate,
- Age 65 and over,
- No cognitive-mental problems,
- Standard Mini Mental Test (SMMT) score of 24 and above,
Key exclusion criteria (3 listed)
- Unconscious,
- Unable to communicate,
- Under 65 years of age
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 |
|---|---|---|
| 4-7-8 Breathing Exercise with Teach-Back MethodIn the experimental group, patients will be provided with information regarding the purpose and significance of the 4-7-8 breathing technique using the Teach-Back method one day before surgery. To confirm comprehension, patients will be asked to repeat the information. The exercise will be demonstrated in a one-on-one session using the Teach-Back method, and patients will be guided through practical application. Following the training, patients will be instructed to perform the exercise independently, with the researcher monitoring its correct implementation. Each patient will be given a "4-7-8 Breathing Exercise Application Guide," which outlines the exercise steps based on relevant literature. Before surgery, patients will complete the "Patient Information Form," the Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI), and the Richards-Campbell Sleep Questionnaire (RCSQ). Postoperatively, the VAS and STAI will be administered both before (pre-test) and after | Other | 4-7-8 Breathing Exercise with Teach-Back Method |
Primary outcome
Richard Campbell Sleep Quality Scale
Time frame: 24 hours
This scale evaluates the depth of night sleep, the time it takes to fall asleep, the frequency of waking up, the time it takes to stay awake when you wake up, the quality of sleep and the noise levels in the environment. When filling out the scale, the person is asked to mark the appropriate option for each item on a chart consisting of 6 items, each item being between 0 and 100. The scale is evaluated with the visual analog scale technique. The score between "0-25" from the scale indicates very bad sleep, and the score between "76-100" indicates very good sleep. The total score of the scale is evaluated based on the first 5 items. The 6th item evaluates the noise level in the environment and is not included in the total score evaluation. As a result, it is concluded that the sleep quality of the participants increases as the total score increases.
State Anxiety Scale
Time frame: 24 hours
The scale consists of 20 questions that measure state anxiety. The "State Anxiety Scale (STAI FORM TX-I, DKO)" requires the individual to express how he/she feels at a certain moment and under certain conditions. A minimum of 20 and a maximum of 80 points can be obtained from each subscale, with higher scores indicating a higher level of anxiety.
Visual Comparison Scale
Time frame: 24 hours
This scale, developed to determine the intensity of pain, is a 10 cm ruler scale with "No Pain" written on one end and "Unbearable Pain" on the other. It consists of numbers divided into equal intervals of one cm between the starting point where there is no pain and the point marked by the patient. In the evaluation of this scale, 0 = no pain, 1-4 = mild pain, 5-6 = moderate pain, 7-8 = severe pain and 10 = unbearable pain
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 6 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be openly shared. However, data may be available upon reasonable request and with appropriate ethical approval.
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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.
Yasemin Erden, Assistant Professor study director
Erzurum Technical University Faculty of Helath Science
Tülay Kılınç, Assistant Professor principal investigator
Ataturk University Faculty of Nursing
Zeynep Bal principal investigator
Firat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-7-8 Breathing Exercise with Teach-Back Method in people with Patients With Total Knee Arthroplasty, run by Erzurum Technical 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 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?
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?
Richard Campbell Sleep Quality Scale (time frame: 24 hours). The study lists 3 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 6 Apr 2025.