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

NCT07651228 | Not Yet Recruiting

• 1 other identifier: ASMR-2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Surgery Patients; Sleep Quality; Postoperative Sleep Disturbance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative nights 1 and 2

Study Arms (3)

ASMR Group

EXPERIMENTAL

Participants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period.

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.

Behavioral: White Noise Audio Intervention

Control Group

NO INTERVENTION

Participants will receive routine postoperative care and will wear headphones without audio playback before sleep.

Interventions

ASMR Audio Intervention BEHAVIORAL

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

Also known as: ASMR Group

ASMR Group

White Noise Audio Intervention BEHAVIORAL

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

Also known as: White Noise Group

White Noise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• muzeyyen ataseven: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Müzeyyen Ataseven, PhD,RN

  Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Müzeyyen Ataseven, PhD, RN

CONTACT

+905052299474; muzeyyenataseven@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation during data analysis and outcome evaluation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, RN, Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 5, 2026
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): January 5, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)