Diabetes Type 2NCT07770204
Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
A study testing Meditation Music Group in people with Diabetes Type 2, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Meditation Music Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü Devlet Hastanesi
Istanbul, Istanbul, 34520
Rumeysa ÇELİK, BSN, +905453178061, rumeysabayram26@gmail.com
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Conditions
- Diabetes Type 2
- Being tested
- Meditation Music Group
- Keywords
- Perioperative Care, Meditation Music, Elective Surgery, Anxiety, Sleep Quality, Glycemic Control, Nursing Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation Music GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Meditation Music Group | Experimental | 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. Receives: Behavioral: Meditation Music Group |
| Control Group | No intervention | Participants will receive routine perioperative care according to the institution's standard clinical practice without the meditation music intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Morning of surgery (before surgery), postoperative evening (on the day of surgery), and postoperative day 1 (morning).
Secondary outcomes (2)
Anxiety
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI).
Measured: 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.
Measured: Baseline at hospital admission, assessing sleep during the night before hospitalization, and postoperative day 1 at hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start3 Jun 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asiye TAN, Istanbul Aydın University
- Investigators
- Asiye TAN, Phd, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770204
- Sponsor's protocol ID
- 218/2026
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07770204
- Acronym / sponsor ID
- 218/2026
- Conditions
- Diabetes Type 2
- Keywords
- Perioperative Care, Meditation Music, Elective Surgery, Anxiety, Sleep Quality, Glycemic Control, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Meditation Music Group | Experimental | Behavioral: Meditation Music GroupParticipants 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 intervention | –Participants will receive routine perioperative care according to the institution's standard clinical practice without the meditation music intervention. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 diabetes mellitus.
- Scheduled to undergo elective surgery.
- Aged 40 to 70 years.
- Mentally and psychologically competent.
- Able to communicate effectively.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation Music GroupParticipants 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. | Behavioural | Meditation Music Group |
Primary outcome
Blood Glucose Level (mg/dL)
Time frame: 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.
2 secondary outcomes
Anxiety
Time frame: Baseline (at hospital admission) and postoperative day 1 (at hospital discharge)
Sleep Quality
Time frame: Baseline at hospital admission, assessing sleep during the night before hospitalization, and postoperative day 1 at hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asiye TAN, Phd principal investigator
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation Music Group in people with Diabetes Type 2, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asiye TAN, Phd (+905055675275, asiyetan@aydin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Level (mg/dL) (time frame: Morning of surgery (before surgery), postoperative evening (on the day of surgery), and postoperative day 1 (morning).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.