Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
Effects of a Meditation Music Intervention on Glycemic Control, Anxiety, and Sleep Quality in Patients With Type 2 Diabetes Mellitus Undergoing Elective Surgery: A Randomized Controlled Trial
1 other identifier
interventional
84
1 country
1
Brief Summary
Patients with type 2 diabetes mellitus undergoing elective surgery are at increased risk of perioperative hyperglycemia, anxiety, and poor sleep quality because of the physiological and psychological stress associated with surgery. These factors may negatively affect postoperative recovery and increase the risk of complications. Music-based interventions are safe, inexpensive, and non-pharmacological approaches that may reduce anxiety, improve sleep quality, and help regulate physiological stress responses. However, evidence regarding the effects of perioperative meditation music on glycemic control, anxiety, and sleep quality in patients with type 2 diabetes undergoing elective surgery remains limited. This randomized controlled trial aims to evaluate the effectiveness of perioperative meditation music in adults with type 2 diabetes mellitus undergoing elective surgery. Participants will be randomly assigned to either an intervention group receiving routine perioperative care plus meditation music or a control group receiving routine perioperative care alone. The intervention group will listen to self-selected meditation music at predefined perioperative time points before and after surgery. Brief Summary The primary objective is to determine whether perioperative meditation music improves postoperative glycemic control. Secondary objectives are to evaluate its effects on anxiety levels and sleep quality. Anxiety will be assessed using the State Anxiety Inventory (STAI-State), sleep quality will be measured using the Richards-Campbell Sleep Questionnaire, and glycemic control will be evaluated using routinely measured blood glucose values. The findings of this study may provide evidence for the use of meditation music as a simple, safe, and cost-effective nursing intervention to improve perioperative outcomes in patients with type 2 diabetes mellitus undergoing elective surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2026
CompletedFirst Submitted
Initial submission to the registry
August 5, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 18, 2026
August 1, 2026
9 months
August 5, 2026
August 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Glucose Level (mg/dL)
Glycemic control will be assessed by measuring blood glucose levels (mg/dL) according to the hospital's routine perioperative blood glucose monitoring protocol. Blood glucose values obtained at the predefined assessment time points will be compared between the intervention and control groups.
Morning of surgery (before surgery), postoperative evening (on the day of surgery), and postoperative day 1 (morning).
Secondary Outcomes (2)
Anxiety
Baseline (at hospital admission) and postoperative day 1 (at hospital discharge)
Sleep Quality
Baseline at hospital admission, assessing sleep during the night before hospitalization, and postoperative day 1 at hospital discharge.
Study Arms (2)
Meditation Music Group
EXPERIMENTALParticipants in this group will receive routine perioperative care in addition to a structured meditation music intervention delivered before and after elective surgery according to the study protocol.
Control Group
NO INTERVENTIONParticipants will receive routine perioperative care according to the institution's standard clinical practice without the meditation music intervention.
Interventions
Participants will receive routine perioperative care in addition to a meditation music intervention. Each participant will select one piece from a predefined list of 6-8 meditation music options. The selected music will be delivered through headphones at predefined time points before and after elective surgery according to the study protocol.
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes mellitus.
- Scheduled to undergo elective surgery.
- Aged 40 to 70 years.
- Mentally and psychologically competent.
- Able to communicate effectively.
- Willing to participate and able to provide written informed consent.
You may not qualify if:
- Severe hearing impairment or use of a hearing aid.
- Diagnosis of severe depression, anxiety disorder, or cognitive impairment (e.g., dementia or Alzheimer's disease).
- Initiation of anxiolytic, sedative, or hypnotic medication within the previous month.
- History of substance abuse or severe alcohol use disorder.
- Diagnosis of type 1 diabetes mellitus or use of an insulin pump.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beylikdüzü Devlet Hastanesi
Istanbul, Istanbul, 34520, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asiye TAN, Phd
Istanbul Aydın University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study. Due to the nature of the meditation music intervention, participants and care providers cannot be blinded to treatment allocation.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2026
First Posted
August 18, 2026
Study Start
June 3, 2026
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
August 18, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share