Arthroplasty, Replacement, Knee, HipNCT07858058
The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty
A study testing White Noise Intervention and Pink Noise Intervention in people with Arthroplasty, Replacement, Knee, Hip and Postoperative Nausea and Vomiting, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting, Anxiety
- What is being tested?
- White Noise Intervention and Pink Noise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2026to 15 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Intact hearing ability (no self-reported or diagnosed severe hearing loss)
- Voluntarily agreed to participate in the study and signed written informed consent
Who cannot join
- 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
- Active ear infection, dermatological lesions, or anatomical deformities preventing the use of over-ear headphones
- Severe tinnitus, hyperacusis, or hearing aid usage
- Emergency surgery, bilateral procedures, or revision arthroplasty
- Known history of substance or alcohol dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital
Erzincan, Merkez, 24000
Mehmet Günay Uyar, PhD, 05543488391, mgu38@hotmail.com
About this study
Official title: The Effect of White and Pink Noise on Sleep, Anxiety and Physiological Parameters in Patients Undergoing Total Hip and Knee Arthroplasty: A Randomized Controlled 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).
- Conditions
- Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting, Anxiety, Postoperative Pain After Arthroscopic Knee Surgery, Sleep Quality
- Being tested
- White Noise Intervention, Pink Noise Intervention
- Keywords
- Coloured noise, Total knee arthroplasty, Total hip arthroplasty, Sleep quality, Preoperative anxiety, Postoperative pain, Postoperative nausea, Nursing intervention
- Medical subject headings
- Postoperative Nausea and Vomiting, Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Noise InterventionBehavioural
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 InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| White Noise Group | Experimental | Participants will listen to standardized white noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones on the preoperative evening (at 10:00 PM) before elective total hip or knee arthroplasty. Receives: Behavioral: White Noise Intervention |
| Pink Noise Group | Experimental | Participants will listen to standardized pink noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones on the preoperative evening (at 10:00 PM) before elective total hip or knee arthroplasty. Receives: Behavioral: Pink Noise Intervention |
| Control Group | No intervention | Participants will receive standard routine perioperative care and nursing management without any auditory intervention or headphone application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessed on the morning of surgery (at approximately 07:00 AM, following the preoperative night intervention).
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.
Measured: Assessed at baseline (pre-intervention, preoperative evening around 21:30) and immediately after the 30-minute intervention (preoperative evening around 22:30).
Secondary outcomes (2)
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.
Measured: Baseline (preoperative evening, immediately before intervention at approximately 21:30) and immediately post-intervention (approximately 22:30)
Heart Rate
Heart rate measured in beats per minute (bpm) using a clinical monitor to evaluate autonomic nervous system responses to auditory interventions.
Measured: Baseline (preoperative evening, immediately before intervention at approximately 21:30) and immediately post-intervention (approximately 22:30)
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 start10 Oct 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, Knee, HipStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Model description
- A prospective, randomized, controlled, parallel-group clinical trial with three arms: White Noise group, Pink Noise group, and Control group (allocation ratio 1:1:1). Eligible participants undergoing elective total knee or hip arthroplasty are stratified by type of surgery (knee vs. hip) and allocated into the three parallel groups using computer-generated block randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Gunay Uyar, Ataturk University
- Investigators
- Mehmet Günay Uyar, PhD, Principal investigator, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858058
- Sponsor's protocol ID
- 2026-09/02
- Status last verified
- Oct 2026
- First submitted
- 27 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
- Undecided
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 White and Pink Noise on Sleep, Anxiety and Physiological Parameters in Patients Undergoing Total Hip and Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07858058
- Acronym / sponsor ID
- 2026-09/02
- Conditions
- Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting, Anxiety, Postoperative Pain After Arthroscopic Knee Surgery, Sleep Quality
- Keywords
- Coloured noise, Total knee arthroplasty, Total hip arthroplasty, Sleep quality, Preoperative anxiety, Postoperative pain, Postoperative nausea, Nursing intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- 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 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, randomized, controlled, parallel-group clinical trial with three arms: White Noise group, Pink Noise group, and Control group (allocation ratio 1:1:1). Eligible participants undergoing elective total knee or hip arthroplasty are stratified by type of surgery (knee vs. hip) and allocated into the three parallel groups using computer-generated block randomization.
| Arm | Type | Receives |
|---|---|---|
| White Noise Group | Experimental | Behavioral: White Noise InterventionParticipants will listen to standardized white noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones on the preoperative evening (at 10:00 PM) before elective total hip or knee arthroplasty. |
| Pink Noise Group | Experimental | Behavioral: Pink Noise InterventionParticipants will listen to standardized pink noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones on the preoperative evening (at 10:00 PM) before elective total hip or knee arthroplasty. |
| Control Group | No intervention | –Participants will receive standard routine perioperative care and nursing management without any auditory intervention or headphone application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Intact hearing ability (no self-reported or diagnosed severe hearing loss)
Key exclusion criteria (8 listed)
- 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
- Active ear infection, dermatological lesions, or anatomical deformities preventing the use of over-ear headphones
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 |
|---|---|---|
| White Noise InterventionParticipants 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). | Behavioural | White Noise Group |
| Pink Noise InterventionParticipants 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). | Behavioural | Pink Noise Group |
Primary outcome
Preoperative Sleep Quality
Time frame: Assessed on the morning of surgery (at approximately 07:00 AM, following the preoperative night intervention).
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).
Preoperative 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).
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.
2 secondary outcomes
Systolic and Diastolic Blood Pressure
Time frame: Baseline (preoperative evening, immediately before intervention at approximately 21:30) and immediately post-intervention (approximately 22:30)
Heart Rate
Time frame: Baseline (preoperative evening, immediately before intervention at approximately 21:30) and immediately post-intervention (approximately 22:30)
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 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet Günay Uyar, PhD principal investigator
Erzincan Binali Yildirim Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Noise Intervention and Pink Noise Intervention in people with Arthroplasty, Replacement, Knee, Hip and Postoperative Nausea and Vomiting, run by Ataturk 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 6 inclusion and 8 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: opening soon, 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?
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?
Contact Mehmet Günay Uyar, PhD (05543488391, mehmet.uyar@erzincan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Sleep Quality (time frame: Assessed on the morning of surgery (at approximately 07:00 AM, following the preoperative night intervention).). The study lists 2 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 5 Oct 2026.