Skip to content

Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery

Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07651228
Acronym
SLEEP-ASMR
Enrollment
90
Registered
2026-06-16
Start date
2026-09-05
Completion date
2027-01-05
Last updated
2026-06-16

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

Conditions

Orthopedic Surgery Patients, Postoperative Sleep Disturbance, Sleep Quality

Keywords

ASMR, White Noise, Sleep Quality, Orthopedic Surgery, Lower Extremity Surgery

Brief 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. 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.

Interventions

BEHAVIORALASMR Audio Intervention

Standardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period.

BEHAVIORALWhite Noise Audio Intervention

Standardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period.

Sponsors

muzeyyen ataseven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors were blinded to group allocation during data analysis and outcome evaluation.

Intervention 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.

Eligibility

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

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Sleep QualityPostoperative nights 1 and 2Postoperative 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTMüzeyyen Ataseven, PhD, RN
muzeyyenataseven@hotmail.com+905052299474
PRINCIPAL_INVESTIGATORMüzeyyen Ataseven, PhD,RN

Medipol University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026