Sleep Quality
Conditions
Brief summary
The purpose of this study is to investigate whether the effects of biofeedback-based music programs using a smart device application can improve perioperative sleep quality in patients undergoing breast cancer surgery.
Detailed description
In a biofeedback-based music group, the patient performs an active respiratory intervention session, which induces a slow breathing pattern. If breathing has been slow enough, the automatic mode is activated to provide music based on the patient's own breathing pattern. The investigators will provide biofeedback-based music, which incorporates the patient's respiratory information, while no intervention will be performed in the control group.
Interventions
DEVICEbiofeedback-based music program
The investigators will provide biofeedback-based music, which incorporates the patient's respiratory information. In a biofeedback-based music group, the patient performs an active respiratory intervention session, which induces a slow breathing pattern. If breathing has been slow enough, the automatic mode is activated to provide music based on patient's own breathing pattern. It automatically will be terminated 30 minutes after intervention.
OTHERControl
The investigators will provide noise-canceling earplugs to minimize bias from noise in the ward.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective breast cancer surgery
Exclusion criteria
* Patients' refusal * Day surgery or urgent surgery * BMI ≥35 * Neurocognitive impairment, hearing disorder (ex : (dementia, impaired cognitive dysfunction, cerebral infarction, transient cerebral ischemic attack)) * Patients with psychiatric diseases, psychological drug intake * Pre-existing conditions associated with sleep disorders or drug intake related to sleep
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Richards-Campbell Sleep Questionnaire on the day of the surgery | The daytime after the surgery (POD1) | sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index | on the day before the surgery | A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. C1-7 (0-3), total (0-21), higher scores mean a worse outcome |
| Quality of recovery score 15 (QoR 15) | on the day before the surgery | Korean version of quality of recovery-15 (0-150), higher scores mean a better outcome |
| Hospital Anxiety and Depression scale | on the day before the surgery | Method to measure anxiety and depression in a general medical population of patient, total (0-42), K-HADS depression subscale(0-21), K-HADS anxiety (0-21), higher scores mean a worse outcome |
| The Richards-Campbell Sleep Questionnaire (baseline, usual patients' pattern) | on the day before the surgery | sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome |
| Postoperative Pain | after the surgery (POD1; Postoperative 24 hours) | NRS score (0-11) of pain, higher scores mean a worse outcome |
| The incidence of postoperative nausea and vomiting | after the surgery (POD1; Postoperative 24 hours) | Postoperative nausea and vomiting |
| The Richards-Campbell Sleep Questionnaire on the day before the surgery | on the day of the surgery before surgery | sleep quality questionnaires that are most commonly used in the ICU setting, RCSQ 1-5 (0-100), Average RCSQ (0-100), higher scores mean a better outcome |
| Analgesics requirement | after the surgery (POD1; Postoperative 24 hours) | Analgesics other than opioid requirement |
| Total sleep time (hours) | The daytime after the surgery (POD1) | Duration of sleep |
| Time to fall asleep (minutes) | The daytime after the surgery (POD1) | The time to sleep from intervention |
| Sleep quality (0-100) | The daytime after the surgery (POD1) | VAS score for sleep quality (0-100), higher scores mean a better outcome |
| Sleep disturbance | The daytime after the surgery (POD1) | Awakened from sleep (yes/no) |
| The reasons of sleep disturbance | The daytime after the surgery (POD1) | Ask the patients who answered yes to the question of whether there was a disturbance during sleep. |
| Postoperative opioid consumption | after the surgery (POD1; Postoperative 24 hours) | Postoperative opioid requirement |
Countries
South Korea
Contacts
Primary ContactHojin Lee, MD, PhD
Outcome results
None listed