The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAtaturk University

About this trial

This study aims to investigate the effects of preoperative white noise and pink noise interventions on sleep quality, anxiety, postoperative pain, nausea, and physiological parameters in patients undergoing elective total hip arthroplasty (THA) or total knee arthroplasty (TKA). A total of 165 adult patients will be randomly allocated into three equal groups: a white noise group, a pink noise group, and a control group (55 participants per group). On the evening prior to surgery (around 10:00 PM), participants in the experimental groups will listen to standardized white noise or pink noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones. Participants in the control group will receive routine perioperative care without any auditory intervention. Data regarding sleep quality, anxiety levels, pain intensity, nausea, and hemodynamics (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be collected using validated scales and physiological monitoring before and after the intervention as well as in the postoperative period (at 0, 12, and 24 hours).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for elective primary unilateral total hip or knee arthroplasty

Aged 18 years or older

American Society of Anesthesiologists (ASA) physical status classification I, II, or III

Literate and able to understand, communicate, and independently complete questionnaires in Turkish

Disqualifiers

Diagnosed psychiatric, cognitive, or neurological disorders that impair communication or scale completion

Clinically diagnosed chronic sleep disorders (e.g., severe obstructive sleep apnea, chronic insomnia)

Regular use of sedative-hypnotics, anxiolytics, or psychiatric medications within the last month

Administration of preoperative sedative or hypnotic premedication on the night before surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • White Noise Intervention

    Behavioral

    Participants will listen to standardized white noise played at a volume of 45-50 dB for 30 minutes using over-ear active noise-cancelling headphones on the preoperative night (at approximately 10:00 PM).

  • Pink Noise Intervention

    Behavioral

    Participants will listen to standardized pink noise played at a volume of 45-50 dB for 30 minutes using over-ear active noise-cancelling headphones on the preoperative night (at approximately 10:00 PM).

Treatment groups

165 Participants
are divided into 3 treatment groups
Group A: White Noise GroupExperimental treatment 1 intervention
Group B: Pink Noise GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Preoperative Sleep Quality

Assessed using the Richard-Campbell Sleep Questionnaire (RCSQ). The scale evaluates depth of sleep, falling asleep latency, awakenings, time spent awake, and overall sleep quality (scores range from 0 to 100 mm, where higher scores represent better sleep quality).

Time frame
Assessed on the morning of surgery (at approximately 07:00 AM, following the preoperative night intervention).
2

Preoperative State Anxiety

Assessed using the State-Trait Anxiety Inventory - State Subscale (STAI-S / STAI Form TX-1). The scale consists of 20 items rated on a 4-point Likert scale (1 = Not at all to 4 = Very much so). Total scores range from 20 to 80, with higher scores reflecting greater levels of acute state anxiety.

Time frame
Assessed at baseline (pre-intervention, preoperative evening around 21:30) and immediately after the 30-minute intervention (preoperative evening around 22:30).

Secondary outcomes

1

Systolic and Diastolic Blood Pressure

Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) using a calibrated clinical monitor to evaluate autonomic nervous system responses to auditory interventions.

Time frame
Baseline (preoperative evening, immediately before intervention at approximately 21:30) and immediately post-intervention (approximately 22:30)
2

Heart Rate

Heart rate measured in beats per minute (bpm) using a clinical monitor to evaluate autonomic nervous system responses to auditory interventions.

Time frame
Baseline (preoperative evening, immediately before intervention at approximately 21:30) and immediately post-intervention (approximately 22:30)

Other outcomes

Sponsors and contacts

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