OsteoarthitisNCT07857876
The Effect of Mindfulness Therapy on Anxiety, Pain, and Sleep Quality in Patients Undergoing Knee Arthroplasty Surgery: A Randomized Controlled Trial
A study testing Mindfulness Therapy in people with Osteoarthitis and Knee Arthroplasty, Total, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled trial to determine the effect of mindfulness therapy on anxiety, pain, and sleep quality in patients undergoing total knee arthroplasty surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthitis, Knee Arthroplasty, Total, Postoperative Pain
- What is being tested?
- Mindfulness Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2026to 17 Aug 2026
- 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
- Undergoing total knee arthroplasty surgery
- Aged 18 years or older
- Having full orientation to person, place, and time
- Having a scheduled post-operative hospital stay of at least three days in the ward
- Volunteering to participate in the study
Who cannot join
- Having an uncontrolled systemic disease or a psychological disorder
- Developing a life-threatening post-operative complication
- Requesting to withdraw from the study at any stage
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted as a randomized controlled trial to determine the effect of mindfulness therapy on anxiety, pain, and sleep quality in patients undergoing total knee arthroplasty surgery. The study was carried out with a total of 72 patients (36 in the intervention group, 36 in the control group) who underwent surgery in the Orthopedics and Traumatology Clinic.
Read the detailed description
Patients in the intervention group received 15-20 minutes of face-to-face mindfulness therapy sessions led by a certified researcher on the morning of the surgery day and at 10:00 AM on postoperative days 1 and 2. The mindfulness protocol consisted of breathing awareness, focus on the present moment, and sensory engagement exercises. Patients in the control group received standard hospital care without any additional intervention. Anxiety levels were evaluated using the State Anxiety Inventory (SAI), postoperative pain intensity was measured using the Visual Analog Scale (VAS), and subjective sleep quality was assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). Physiological parameters including systolic blood pressure, diastolic blood pressure, and pulse rate were also monitored before and after the sessions.
- Conditions
- Osteoarthitis, Knee Arthroplasty, Total, Postoperative Pain
- Being tested
- Mindfulness Therapy
- Keywords
- Mindfulness, Anxiety, Sleep Quality, Nursing Care
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TherapyBehavioural
The mindfulness therapy sessions lasted approximately 15-20 minutes and were delivered face-to-face by a certified researcher. The protocol involved placing the patient in a comfortable seating position with adjusted height, closed eyes (or a downward gaze), focused deep breathing, and structured mindfulness exercises engaging the five senses (focusing on sights, physical touch, sounds, scents, and tastes).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients in this group received 15-20 minutes of face-to-face mindfulness therapy sessions led by a certified researcher. The sessions were conducted on the surgery day before the operation (at 07:00 AM) and at 10:00 AM on postoperative days 1 and 2. The mindfulness therapy included relaxation in a comfortable seating position, focused breathing, and mindfulness exercises utilizing the five senses. Receives: Behavioral: Mindfulness Therapy |
| Control Group | No intervention | Patients in this group received routine care without any additional interventions. Data collection scales and instruments were administered to the control group at the same time intervals as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Inventory (STAI-S) Scores
The scale evaluates the temporary anxiety levels of patients. It consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate a higher level of anxiety. The change in anxiety scores will be evaluated by comparing pre-test and post-test values across the measurement points.
Measured: Day of surgery (measured immediately before and after the 07:00 AM mindfulness therapy session), Post-operative Day 1 and Day 2 (measured immediately before and after the 10:00 AM mindfulness therapy session)
Secondary outcomes (2)
Change in Visual Analog Scale (VAS) Pain Scores
The scale evaluates the subjective pain levels of patients. It consists of a 10 cm line where 0 indicates "no pain" and 10 indicates "the worst possible pain". Higher scores represent higher pain intensity. The change in pain scores will be evaluated by comparing pre-test and post-test values across the measurement points.
Measured: Post-operative Day 1 (measured immediately before and after the 10:00 AM mindfulness therapy session) and Post-operative Day 2 (measured immediately before and after the 10:00 AM mindfulness therapy session).
Richard-Campbell Sleep Questionnaire (RCSQ) Scores
The questionnaire evaluates the sleep quality of patients. It consists of 5 items scored from 0 to 100 on a visual analog scale, with higher scores representing better sleep quality.
Measured: Day of surgery at 07:00 AM (pre-session), Post-operative Day 1 at 10:00 AM (pre-session), Post-operative Day 2 at 10:00 AM (pre-session), and Post-operative Day 3 morning (follow-up sleep measurement without therapy session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start13 Apr 2026
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857876
- Sponsor's protocol ID
- OMÜ KAEK 2025/492
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Therapy on Anxiety, Pain, and Sleep Quality in Patients Undergoing Knee Arthroplasty Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07857876
- Acronym / sponsor ID
- OMÜ KAEK 2025/492
- Conditions
- Osteoarthitis, Knee Arthroplasty, Total, Postoperative Pain
- Keywords
- Mindfulness, Anxiety, Sleep Quality, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 5 Oct 2026 (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 study was conducted as a randomized controlled trial to determine the effect of mindfulness therapy on anxiety, pain, and sleep quality in patients undergoing total knee arthroplasty surgery. The study was carried out with a total of 72 patients (36 in the intervention group, 36 in the control group) who underwent surgery in the Orthopedics and Traumatology Clinic.
Detailed description
Patients in the intervention group received 15-20 minutes of face-to-face mindfulness therapy sessions led by a certified researcher on the morning of the surgery day and at 10:00 AM on postoperative days 1 and 2. The mindfulness protocol consisted of breathing awareness, focus on the present moment, and sensory engagement exercises. Patients in the control group received standard hospital care without any additional intervention. Anxiety levels were evaluated using the State Anxiety Inventory (SAI), postoperative pain intensity was measured using the Visual Analog Scale (VAS), and subjective sleep quality was assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). Physiological parameters including systolic blood pressure, diastolic blood pressure, and pulse rate were also monitored before and after the sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mindfulness TherapyPatients in this group received 15-20 minutes of face-to-face mindfulness therapy sessions led by a certified researcher. The sessions were conducted on the surgery day before the operation (at 07:00 AM) and at 10:00 AM on postoperative days 1 and 2. The mindfulness therapy included relaxation in a comfortable seating position, focused breathing, and mindfulness exercises utilizing the five senses. |
| Control Group | No intervention | –Patients in this group received routine care without any additional interventions. Data collection scales and instruments were administered to the control group at the same time intervals as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing total knee arthroplasty surgery
- Aged 18 years or older
- Having full orientation to person, place, and time
- Having a scheduled post-operative hospital stay of at least three days in the ward
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Having an uncontrolled systemic disease or a psychological disorder
- Developing a life-threatening post-operative complication
- Requesting to withdraw from the study at any stage
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 |
|---|---|---|
| Mindfulness TherapyThe mindfulness therapy sessions lasted approximately 15-20 minutes and were delivered face-to-face by a certified researcher. The protocol involved placing the patient in a comfortable seating position with adjusted height, closed eyes (or a downward gaze), focused deep breathing, and structured mindfulness exercises engaging the five senses (focusing on sights, physical touch, sounds, scents, and tastes). | Behavioural | Intervention Group |
Primary outcome
Change in State Anxiety Inventory (STAI-S) Scores
Time frame: Day of surgery (measured immediately before and after the 07:00 AM mindfulness therapy session), Post-operative Day 1 and Day 2 (measured immediately before and after the 10:00 AM mindfulness therapy session)
The scale evaluates the temporary anxiety levels of patients. It consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate a higher level of anxiety. The change in anxiety scores will be evaluated by comparing pre-test and post-test values across the measurement points.
2 secondary outcomes
Change in Visual Analog Scale (VAS) Pain Scores
Time frame: Post-operative Day 1 (measured immediately before and after the 10:00 AM mindfulness therapy session) and Post-operative Day 2 (measured immediately before and after the 10:00 AM mindfulness therapy session).
Richard-Campbell Sleep Questionnaire (RCSQ) Scores
Time frame: Day of surgery at 07:00 AM (pre-session), Post-operative Day 1 at 10:00 AM (pre-session), Post-operative Day 2 at 10:00 AM (pre-session), and Post-operative Day 3 morning (follow-up sleep measurement without therapy session).
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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 Mindfulness Therapy in people with Osteoarthitis and Knee Arthroplasty, Total, run by Saglik Bilimleri Universitesi 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 5 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: finished, as of the sponsor's last update on 5 Oct 2026. 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?
Change in State Anxiety Inventory (STAI-S) Scores (time frame: Day of surgery (measured immediately before and after the 07:00 AM mindfulness therapy session), Post-operative Day 1 and Day 2 (measured immediately before and after the 10:00 AM mindfulness therapy session)). 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 5 Oct 2026.