Skip to content

The Effect of Mindfulness Therapy on Anxiety, Pain, and Sleep Quality in Patients Undergoing Knee Arthroplasty Surgery: A Randomized Controlled Trial

The Effect of Mindfulness Therapy on Anxiety, Pain, and Sleep Quality in Patients Undergoing Knee Arthroplasty Surgery: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07857876
Enrollment
72
Registered
2026-10-05
Start date
2026-04-13
Completion date
2026-08-17
Last updated
2026-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthitis, Knee Arthroplasty, Total, Postoperative Pain

Keywords

Mindfulness, Anxiety, Sleep Quality, Nursing Care

Brief 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. 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.

Interventions

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).

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in State Anxiety Inventory (STAI-S) ScoresDay 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.

Secondary

MeasureTime frameDescription
Change in Visual Analog Scale (VAS) Pain ScoresPost-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).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.
Richard-Campbell Sleep Questionnaire (RCSQ) ScoresDay 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).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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 6, 2026