Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
Sponsorİstanbul Aydın Üniversitesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with type 2 diabetes mellitus.

Scheduled to undergo elective surgery.

Aged 40 to 70 years.

Mentally and psychologically competent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Meditation Music Group

    Behavioral

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Meditation Music GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
Morning of surgery (before surgery), postoperative evening (on the day of surgery), and postoperative day 1 (morning).

Secondary outcomes

1

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)
2

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.

Other outcomes

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