Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07651228

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34810, Turkey (Türkiye)

Location contact

Müzeyyen Ataseven, PhD, RN

CONTACT

[email protected]

+905052299474

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASMR Audio Intervention

Behavioral

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

Other names: ASMR Group

White Noise Audio Intervention

Behavioral

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

Other names: White Noise Group

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Müzeyyen Ataseven, PhD, RN

CONTACT

[email protected]

+905052299474

Sponsors and collaborators

Lead sponsor

muzeyyen ataseven

Other

Registry information

Official study title

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

Acronym: SLEEP-ASMR

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.