Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsormuzeyyen ataseven
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and older
Undergoing elective lower extremity surgery
Conscious and able to communicate
No hearing impairment or hearing aid use
Disqualifiers
Participation in another clinical study
Surgery due to trauma
Transfer to the intensive care unit during the postoperative period
Development of serious postoperative complications
Trial design
Design model
Parallel
Treatments tested in this trial
ASMR Audio Intervention
BehavioralStandardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period.
White Noise Audio Intervention
BehavioralStandardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: ASMR GroupExperimental treatment 1 intervention
Group B: White Noise GroupExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Postoperative nights 1 and 2Sponsors and contacts
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muzeyyen ataseven
Lead sponsor
Istanbul Medipol University Hospital
Sponsor institution
Source ClinicalTrials.gov
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