An interventional study of Meditation Music Group in Diabetes Type 2, sponsored by Istanbul Aydın University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Istanbul Aydın University · Not applicable, Interventional, and Supportive care
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.
Detailed Description
Type 2 diabetes mellitus (T2DM) is associated with an increased risk of perioperative hyperglycemia, delayed wound healing, postoperative infections, prolonged hospitalization, and other surgical complications. In addition to metabolic disturbances, the psychological stress associated with elective surgery may increase anxiety levels, disrupt sleep quality, and further impair glycemic control through activation of neuroendocrine stress pathways.
Music-based interventions have been recognized as safe, inexpensive, and non-pharmacological strategies for reducing perioperative stress and improving patient comfort. Previous studies have demonstrated beneficial effects of music on anxiety, physiological stress responses, and postoperative recovery. However, evidence regarding the effectiveness of perioperative meditation music on glycemic control, anxiety, and sleep quality specifically in patients with T2DM undergoing elective surgery remains limited.
The purpose of this randomized controlled trial is to determine whether perioperative meditation music, when provided in addition to routine perioperative care, improves postoperative glycemic control, reduces anxiety, and enhances sleep quality in adults with T2DM undergoing elective surgery.
Participants will be randomly assigned to either an intervention group receiving routine perioperative care plus self-selected meditation music or a control group receiving routine perioperative care alone. The music intervention will be delivered at predefined perioperative time points before and after surgery using standardized procedures.
Clinical, physiological, and patient-reported outcomes will be collected throughout the perioperative period to evaluate the effectiveness of the intervention. The findings are expected to provide evidence regarding the integration of meditation music into perioperative nursing care as a safe, feasible, and cost-effective complementary intervention for patients with T2DM undergoing elective surgery.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 84 is close to the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Istanbul Aydın University is the lead sponsor of 70 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Behavioral: Meditation Music Group
Participants will receive routine perioperative care according to the institution's standard clinical practice without the meditation music intervention.
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.
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.
Time frame: Morning of surgery (before surgery), postoperative evening (on the day of surgery), and postoperative day 1 (morning).
Anxiety
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI).
Time frame: Baseline (at hospital admission) and postoperative day 1 (at hospital discharge)
Sleep Quality
Sleep quality will be assessed using the Richard-Campbell Sleep Questionnaire (RCSQ). At baseline, participants will rate their sleep during the night before hospitalization. Sleep quality will be reassessed on postoperative day 1 at hospital discharge.
Time frame: Baseline at hospital admission, assessing sleep during the night before hospitalization, and postoperative day 1 at hospital discharge.
Plan to share: No
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Istanbul Aydın University