Diabetes Type 2
Conditions
Keywords
Perioperative Care, Meditation Music, Elective Surgery, Anxiety, Sleep Quality, Glycemic Control, Nursing Intervention
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.
Detailed description
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.
Interventions
BEHAVIORALMeditation Music Group
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.
Sponsors
İstanbul Aydın Üniversitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the intervention group, receiving routine perioperative care plus meditation music, or the control group, receiving routine perioperative care alone. Participants will remain in their assigned groups throughout the study, and outcomes will be compared between the two parallel groups.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Level (mg/dL) | Morning of surgery (before surgery), postoperative evening (on the day of surgery), and postoperative day 1 (morning). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Baseline (at hospital admission) and postoperative day 1 (at hospital discharge) | Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). |
| Sleep Quality | Baseline at hospital admission, assessing sleep during the night before hospitalization, and postoperative day 1 at hospital discharge. | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAsiye TAN, Phd
CONTACTRumeysa ÇELİK, BSN
PRINCIPAL_INVESTIGATORAsiye TAN, Phd
Istanbul Aydın University
Outcome results
None listed