NCT07171008

Brief Summary

This randomized controlled study aims to investigate the effects of ney music listening, a traditional Turkish wind instrument, on pain, anxiety, sleep quality, and vital signs in patients undergoing lumbar disc herniation surgery. Participants will be randomly assigned to intervention and control groups. The intervention group will receive a 15-minute ney music session at three different time points: preoperative (on the day of surgery), postoperative 3rd hour, and postoperative day 1. The control group will receive standard postoperative nursing care without music intervention. Data will be collected at the same time points in both groups using the Visual Analog Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Richard-Campbell Sleep Questionnaire, and vital signs. The study seeks to evaluate the non-pharmacological benefits of therapeutic music in postoperative recovery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

July 31, 2025

Last Update Submit

November 23, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Effect of Ney Music on Pain

    Visual Analog Scale: The Visual Analog Scale is a commonly used unidimensional measure for assessing pain intensity. The VAS is a measurement tool ranging from 0 to 10 cm (0 to 100 mm) in length. Since the aim of the study is to determine the effect of the non-pharmacological method used on the current pain, the VAS will be used in the assessment of pain before and after application. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

    6 month

  • The Effect Ney Music on Anxiety

    State Anxiety Inventory: In our study, the State Anxiety Inventory will be used before and after the procedure to assess patients' anxiety levels in a specific situation. The State Anxiety Inventory (STAI-I) is a tool that measures how an individual feels at a specific moment and in a specific situation, i.e., their anxiety level in that situation.Each subscale consists of 20 items, and the inventory consists of a total of 40 items. When calculating the State Anxiety Inventory, the scoring is reversed for items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The total score from both scales in the inventory ranges from 20 to 80. High scores on the scales indicate high anxiety, while low scores indicate low anxiety levels. Measurements will be taken at the following intervals: On the day of surgery, before surgery;Three hours after surgery (after transfer to the clinic); On the morning of the first day after surgery

    6 month

  • The Effect Ney Music on Sleep

    Richard-Campbell Sleep Scale: Assesses the depth of nighttime sleep, the time it takes to fall asleep, the frequency of waking up, the time spent awake after waking up, the quality of sleep, and the noise level in the environment. Each item is rated on a scale ranging from 0 to 100 using the Visual Analog Scale technique. A score between "0-25" on the scale indicates very poor sleep, while a score between "76-100" indicates very good sleep. The total scale score is evaluated based on five items, excluding the 6th item, which assesses the noise level in the environment, with a total score of 22. As the scale score increases, patients' sleep quality also improves. It will be used to evaluate the effect of non-pharmacological interventions on patients' sleep levels after surgery. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

    6 month

  • The Effect Ney Music on blood pressure

    Patients' blood pressure, values will be recorded. The effect of non-pharmacological interventions on patients' blood pressure values will be evaluated. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

    6 month

  • The Effect Ney Music on pulse

    Patients' pulse , values will be recorded. The effect of non-pharmacological interventions on patients' pulse values will be evaluated. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

    6 month

  • The Effect Ney Music on oxygen saturation

    Patients' oxygen saturation , values will be recorded. The effect of non-pharmacological interventions on patients' oxygen saturation values will be evaluated. Measurements will be taken at the following intervals: On the day of surgery, before surgery Three hours after surgery (after transfer to the clinic) On the morning of the first day after surgery

    6 month

Study Arms (2)

Ney Music

EXPERIMENTAL

Participants in this group will receive a 15-minute ney performance in addition to routine nursing care at specified times before and after lumbar disc surgery. The intervention will be carried out in three sessions: I. Session: On the day of surgery, before surgery II. Session: Within the first 3 hours after surgery (after transfer to the clinic) Session III: Morning of the first day after surgery Before and after the application, the Visual Analogue Scale (VAS), State-Trait Anxiety Inventory (STAI-I), Richard-Campbell Sleep Scale, and vital signs (blood pressure, pulse, oxygen saturation) will be measured. Ney pieces in the Rast and Nihavent modes will be used in the sessions.

Other: Ney music

Standard care

NO INTERVENTION

Only standard nursing care will be provided to participants in this group. Parallel to the timing in the intervention group, VAS, STAI-I, Richard-Campbell Sleep Scale, and vital signs will be measured at three separate times (pre-surgery, first 3 hours post-surgery, and first day post-surgery), but no music will be played.

Interventions

Ney music concert

Ney Music

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having undergone lumbar disc surgery under general anesthesia
  • years old and over,
  • At least 3 hours have passed from the analgesic administration,
  • Patients willing to participate in the study will be included in the study.

You may not qualify if:

  • Patient-controlled analgesia (PCA) is applied,
  • Over 70 years old,
  • Using anxiolytic and sedative drugs,
  • Having a psychiatric illness,
  • Patients with communication barriers will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niran Çoban

Yalova, 77000, Turkey (Türkiye)

RECRUITING

Related Publications (10)

  • Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.

    PMID: 30280915BACKGROUND
  • Erdal, B., Kındap Tepe, Y., Öztürk, O. M., Çiğdem, B., Erol, T., Bulut, M. H., et al. (2022). Tarihi Türk müziği makamlarının fizyolojik ve psikolojik etkileri üzerine bir araştırma. Türk Dünyası Sosyal Bilimler Sempozyumu Tam Metin Kitabı. İzmir.

    BACKGROUND
  • Doğan, H. D. (2022). Klasik Türk müziği makamları uygulanarak yapılan hemşirelik doktora tezlerinin değişkenler açısından sistematik incelenmesi. Mersin Üniversitesi Tıp Fakültesi Lokman Hekim Tıp Tarihi ve Folklorik Tıp Dergisi, 12(3), 610-627.

    BACKGROUND
  • Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14.

    PMID: 29248604BACKGROUND
  • Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.

    PMID: 22588748BACKGROUND
  • Karaman, Ö. Z., Özer, N. (2015). Richard-Campbell Uyku Ölçeği geçerlik ve güvenilirlik çalışması. Türk Uyku Tıbbi Dergisi, 2, 29-32.

    BACKGROUND
  • Leonard H. Live Music Therapy During Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. J Music Ther. 2019 Feb 16;56(1):61-89. doi: 10.1093/jmt/thy022.

    PMID: 30770536BACKGROUND
  • Lin LW, Weng SC, Wu HS, Tsai LJ, Lin YL, Yeh SH. The Effects of White Noise on Agitated Behaviors, Mental Status, and Activities of Daily Living in Older Adults With Dementia. J Nurs Res. 2018 Feb;26(1):2-9. doi: 10.1097/JNR.0000000000000211.

    PMID: 29315202BACKGROUND
  • Öner, N., Le Compte, A., Durumluk Sürekli Kaygı Envanteri El Kitabı, 2. Baskı, Boğaziçi Üniversitesi Yayınları, No:333,19.

    BACKGROUND
  • Simcock XC, Yoon RS, Chalmers P, Geller JA, Kiernan HA, Macaulay W. Intraoperative music reduces perceived pain after total knee arthroplasty: a blinded, prospective, randomized, placebo-controlled clinical trial. J Knee Surg. 2008 Oct;21(4):275-8. doi: 10.1055/s-0030-1247831.

    PMID: 18979928BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • NİRAN ÇOBAN

    University of Yalova

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

July 31, 2025

First Posted

September 12, 2025

Study Start

April 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations