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

15 juni 2026 uppdaterad av: muzeyyen ataseven

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ASMR Group
Participants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period.
Beteende: ASMR Audio Intervention
Standardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period.
Andra namn:
  • ASMR Group
Experimentell: White Noise Group
Participants will listen to standardized 30-minute white noise audio recordings before sleep during the postoperative hospitalization period.
Beteende: White Noise Audio Intervention
Standardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period.
Andra namn:
  • White Noise Group
Inget ingripande: Control Group
Participants will receive routine postoperative care and will wear headphones without audio playback before sleep.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative Sleep Quality
Tidsram: 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.
Postoperative nights 1 and 2

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

muzeyyen ataseven

Utredare

  • Huvudutredare: Müzeyyen Ataseven, PhD,RN, Medipol University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

5 september 2026

Primärt slutförande (Beräknad)

5 november 2026

Avslutad studie (Beräknad)

5 januari 2027

Studieregistreringsdatum

Först inskickad

7 juni 2026

Först inskickad som uppfyllde QC-kriterierna

15 juni 2026

Första postat (Faktisk)

16 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ASMR-2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data (IPD) will not be shared to protect participant confidentiality and institutional data security.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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