Postoperative Sleep DisturbanceSLEEP-ASMRNCT07651228
Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery
A study testing ASMR Audio Intervention and White Noise Audio Intervention in people with Postoperative Sleep Disturbance and Orthopedic Surgery Patients, run by muzeyyen ataseven at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effects of Autonomous Sensory Meridian Response (ASMR) and white noise on postoperative sleep quality in patients undergoing elective lower extremity surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sleep Disturbance, Orthopedic Surgery Patients, Sleep Quality
- What is being tested?
- ASMR Audio Intervention and White Noise Audio Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2026to 5 Jan 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
- Age 18 years and older
- Undergoing elective lower extremity surgery
- Conscious and able to communicate
- No hearing impairment or hearing aid use
- Numeric Rating Scale (NRS) pain score of 5 or lower
- No use of medications affecting sleep
- Willing to participate in the study
- Able to provide written informed consent
Who cannot join
- Participation in another clinical study
- Surgery due to trauma
- Transfer to the intensive care unit during the postoperative period
- Development of serious postoperative complications
- Withdrawal from the study at any stage
- Failure to comply with study procedures
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
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34810
Müzeyyen Ataseven, PhD, RN, +905052299474, muzeyyenataseven@hotmail.com
About this study
Official title: Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of Autonomous Sensory Meridian Response (ASMR) and white noise on postoperative sleep quality in patients undergoing elective lower extremity surgery. Postoperative sleep disturbances are common after orthopedic surgery and may negatively affect pain perception, recovery, and overall patient outcomes. Participants will be randomly assigned to one of three groups: ASMR intervention, white noise intervention, or control group. Patients in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative period, while the control group will receive routine care with headphones only. Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). The study aims to determine which non-pharmacological intervention is more effective in improving postoperative sleep quality.
Read the detailed description
Sleep disturbance is one of the most common postoperative complications following orthopedic surgery and is associated with increased pain perception, delayed recovery, prolonged hospitalization, and decreased patient comfort. Non-pharmacological interventions that improve sleep quality may contribute positively to postoperative recovery and patient outcomes.
Autonomous Sensory Meridian Response (ASMR) is characterized by relaxing sensory experiences triggered by auditory stimuli and has recently gained attention for its potential effects on sleep and emotional well-being. White noise is another auditory intervention commonly used to reduce environmental noise perception and promote sleep quality. Although previous studies have demonstrated beneficial effects of ASMR and white noise separately, there is limited evidence comparing these interventions in postoperative orthopedic patients.
This study is designed as a three-arm parallel randomized controlled trial conducted in patients undergoing elective lower extremity surgery. Eligible participants will be randomized in a 1:1:1 ratio into ASMR, white noise, or control groups using computer-generated block randomization. Participants in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative hospitalization period. The control group will receive headphones without audio playback to minimize environmental noise exposure.
The primary outcome of the study is postoperative sleep quality measured using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes may include postoperative pain intensity, nocturnal awakening frequency, and patient comfort. Blinded researchers will perform outcome assessment and statistical analyses.
The findings of this study are expected to provide evidence regarding effective non-pharmacological nursing interventions to improve postoperative sleep quality in orthopedic surgery patients.
- Being tested
- ASMR Audio Intervention, White Noise Audio Intervention
- Keywords
- ASMR, White Noise, Sleep Quality, Orthopedic Surgery, Lower Extremity Surgery
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASMR Audio InterventionBehavioural
Also called ASMR Group
Standardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period.
White Noise Audio InterventionBehavioural
Also called White Noise Group
Standardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| ASMR Group | Experimental | Participants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period. Receives: Behavioral: ASMR Audio Intervention |
| White Noise Group | Experimental | Participants will listen to standardized 30-minute white noise audio recordings before sleep during the postoperative hospitalization period. Receives: Behavioral: White Noise Audio Intervention |
| Control Group | No intervention | Participants will receive routine postoperative care and will wear headphones without audio playback before sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Sleep Quality
Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a validated five-item visual analog scale evaluating sleep depth, sleep latency, number of awakenings, sleep efficiency, and overall sleep quality. Each item is scored between 0 and 100, and higher scores indicate better sleep quality. Total scores are calculated by averaging the item scores. Sleep quality will be evaluated during postoperative nights 1 and 2.
Measured: Postoperative nights 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start5 Sep 2026 (estimated)
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sleep DisturbanceStudies 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
- Model description
- Participants will be randomized in a 1:1:1 ratio into three parallel groups: ASMR intervention, white noise intervention, and control group. Participants assigned to intervention groups will receive standardized 30-minute audio sessions before sleep during the postoperative period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- muzeyyen ataseven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, muzeyyen ataseven, Istanbul Medipol University Hospital
- Investigators
- Müzeyyen Ataseven, PhD,RN, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651228
- Sponsor's protocol ID
- ASMR-2026
- Acronym
- SLEEP-ASMR
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 16 Jun 2026
- 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 shared to protect participant confidentiality and institutional data security.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07651228
- Acronym / sponsor ID
- SLEEP-ASMR / ASMR-2026
- Keywords
- ASMR, White Noise, Sleep Quality, Orthopedic Surgery, Lower Extremity Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- muzeyyen atasevenUniversity, hospital or other
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 16 Jun 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 randomized controlled trial aims to evaluate the effects of Autonomous Sensory Meridian Response (ASMR) and white noise on postoperative sleep quality in patients undergoing elective lower extremity surgery. Postoperative sleep disturbances are common after orthopedic surgery and may negatively affect pain perception, recovery, and overall patient outcomes. Participants will be randomly assigned to one of three groups: ASMR intervention, white noise intervention, or control group. Patients in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative period, while the control group will receive routine care with headphones only. Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). The study aims to determine which non-pharmacological intervention is more effective in improving postoperative sleep quality.
Detailed description
Sleep disturbance is one of the most common postoperative complications following orthopedic surgery and is associated with increased pain perception, delayed recovery, prolonged hospitalization, and decreased patient comfort. Non-pharmacological interventions that improve sleep quality may contribute positively to postoperative recovery and patient outcomes.
Autonomous Sensory Meridian Response (ASMR) is characterized by relaxing sensory experiences triggered by auditory stimuli and has recently gained attention for its potential effects on sleep and emotional well-being. White noise is another auditory intervention commonly used to reduce environmental noise perception and promote sleep quality. Although previous studies have demonstrated beneficial effects of ASMR and white noise separately, there is limited evidence comparing these interventions in postoperative orthopedic patients.
This study is designed as a three-arm parallel randomized controlled trial conducted in patients undergoing elective lower extremity surgery. Eligible participants will be randomized in a 1:1:1 ratio into ASMR, white noise, or control groups using computer-generated block randomization. Participants in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative hospitalization period. The control group will receive headphones without audio playback to minimize environmental noise exposure.
The primary outcome of the study is postoperative sleep quality measured using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes may include postoperative pain intensity, nocturnal awakening frequency, and patient comfort. Blinded researchers will perform outcome assessment and statistical analyses.
The findings of this study are expected to provide evidence regarding effective non-pharmacological nursing interventions to improve postoperative sleep quality in orthopedic surgery patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio into three parallel groups: ASMR intervention, white noise intervention, and control group. Participants assigned to intervention groups will receive standardized 30-minute audio sessions before sleep during the postoperative period.
| Arm | Type | Receives |
|---|---|---|
| ASMR Group | Experimental | Behavioral: ASMR Audio InterventionParticipants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period. |
| White Noise Group | Experimental | Behavioral: White Noise Audio InterventionParticipants will listen to standardized 30-minute white noise audio recordings before sleep during the postoperative hospitalization period. |
| Control Group | No intervention | –Participants will receive routine postoperative care and will wear headphones without audio playback before sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years and older
- Undergoing elective lower extremity surgery
- Conscious and able to communicate
- No hearing impairment or hearing aid use
- Numeric Rating Scale (NRS) pain score of 5 or lower
Key exclusion criteria (6 listed)
- Participation in another clinical study
- Surgery due to trauma
- Transfer to the intensive care unit during the postoperative period
- Development of serious postoperative complications
- Withdrawal 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 |
|---|---|---|
| ASMR Audio InterventionAlso: ASMR GroupStandardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period. | Behavioural | ASMR Group |
| White Noise Audio InterventionAlso: White Noise GroupStandardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period. | Behavioural | White Noise Group |
Primary outcome
Postoperative Sleep Quality
Time frame: Postoperative nights 1 and 2
Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). The RCSQ is a validated five-item visual analog scale evaluating sleep depth, sleep latency, number of awakenings, sleep efficiency, and overall sleep quality. Each item is scored between 0 and 100, and higher scores indicate better sleep quality. Total scores are calculated by averaging the item scores. Sleep quality will be evaluated during postoperative nights 1 and 2.
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 16 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant confidentiality and institutional data security.
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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.
Müzeyyen Ataseven, PhD,RN principal investigator
Medipol 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 ASMR Audio Intervention and White Noise Audio Intervention in people with Postoperative Sleep Disturbance and Orthopedic Surgery Patients, run by muzeyyen ataseven 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 8 inclusion and 6 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 16 Jun 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 Müzeyyen Ataseven, PhD, RN (+905052299474, muzeyyenataseven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Sleep Quality (time frame: Postoperative nights 1 and 2). 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 16 Jun 2026.